This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332) (NCT01135134), a randomized phase 3 study. The primary outcome is Change From Baseline in the Total Nasal Symptom Score at 2 Weeks.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01135134 |
| Phase | Phase 3 |
| Condition | Rhinitis, Allergic, Perennial |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 333 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Organon and Co |
| Results posted | Yes |
2. Clinical Question
Population
Children aged 5 to 15 years with perennial allergic rhinitis were eligible for the study. The registry describes an observation period before eligibility was assessed and randomization took place. The endpoint’s analysis population is not reported in the registry record.
Intervention
The intervention was mometasone furoate nasal spray. The registry describes once-daily morning administration for 2 weeks, with the spray count depending on age: one spray per nostril for ages 5 to 11 years and 2 sprays per nostril for ages 12 to 15 years.
Comparator
The comparator was a placebo nasal spray administered once daily in the morning for 2 weeks. The registry describes the same age-specific spray counts as for the active-treatment arm.
Primary question
The primary question was whether change from baseline in total nasal symptom score at 2 weeks differed between the mometasone furoate nasal spray and placebo groups. The score combines sneezing, rhinorrhea, nasal congestion, and nasal itching; higher scores represent more severe symptoms.
3. Trial Design
The registry describes a completed, phase 3, randomized, parallel-group study of mometasone furoate nasal spray and placebo in pediatric subjects with perennial allergic rhinitis. The study title identifies it as multicenter, double-blind, randomized, and placebo-controlled. The registry’s masking classification is quadruple. These are the classifications recorded; further details about which roles were masked are not reported in the registry record.
The registry lists enrollment as 333. Participants aged 5 to 15 years were to undergo a no-treatment observation period of at least 7 days, after which eligibility was assessed. Eligible participants were randomized to mometasone furoate or placebo for a 2-week double-blind treatment period. The described visits took place at treatment start and after 1 and 2 weeks, or at discontinuation. A follow-up visit 30 days after completion or discontinuation was intended to assess serious adverse events and trial procedure-related adverse events.
The active-treatment description specifies one spray per nostril once daily for ages 5 to 11 years, corresponding to 100 μg/day as mometasone furoate, and 2 sprays per nostril once daily for ages 12 to 15 years, corresponding to 200 μg/day. Both regimens were described as morning administration for 2 weeks. The placebo description specifies the same age-specific spray counts and schedule.
The primary outcome was change from baseline in total nasal symptom score at 2 weeks. A 1-week change in the same score was also posted as a secondary outcome. The original sample-size justification, allocation ratio specified in the protocol, analysis populations, and detailed statistical plan are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | MFNS | Placebo |
|---|---|---|
| STARTED | 220 | 113 |
| COMPLETED | 218 | 112 |
| NOT COMPLETED | 2 | 1 |
Reasons for not completing this period:
| Reason | MFNS | Placebo |
|---|---|---|
| Adverse Event | 1 | 1 |
| Did not meet protocol eligibility | 1 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | MFNS | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 220 | 113 | 333 | |
| Age, Customized: Between 5 and 11 years | Participants | 146 | 74 | 220 |
| Age, Customized: Between 12 and 15 years | Participants | 74 | 39 | 113 |
| Sex: Female, Male: Female | Participants | 90 | 38 | 128 |
| Sex: Female, Male: Male | Participants | 130 | 75 | 205 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in the Total Nasal Symptom Score at 2 Weeks, measured over Baseline and 2 weeks (or discontinuation).
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change from baseline in total nasal symptom score at 2 weeks, or at discontinuation. The score combines ratings for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored from 0, meaning none, to 3, meaning severe, producing a total score ranging from 0 to 12. Higher scores indicate more severe symptoms.
Change from baseline expresses how the score at follow-up differs from the participant’s starting score. A negative change therefore represents a reduction in the score. Comparing average changes between randomized groups provides a way to describe how the groups’ symptom scores changed over the treatment period. The registry reports least-squares means and standard errors for the groups, while the simple recalculation uses the posted group summaries to estimate an unadjusted difference.
Using a composite score allows multiple listed nasal symptoms to contribute to a single outcome. That can make the endpoint more concise than considering each symptom separately, but the combined result does not show how each symptom changed on its own. The registry record does not report the clinical importance threshold for a change in this score, the handling of individual symptom ratings, or the endpoint’s analysis population.
7. Results Posted in the Registry
- MFNS: mean -3.98 versus -1.91 on control; difference -2.08 (95% CI -2.62 to -1.53), standardized effect d = -0.86; z-test p = <0.001.
Mean difference: MFNS
95% CI: -2.62 to -1.53
Recalculated from the posted summary statistics
8. Secondary Efficacy Endpoints
The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.
| Secondary outcome | Type | Effect measure | Estimate (95% CI) | Planning size, 80% power |
|---|---|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score at 1 Week | Continuous Endpoint | Mean difference | -1.30 (-1.78 to -0.83) | 42 per arm |
Change From Baseline in the Total Nasal Symptom Score at 1 Week
- Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
- Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
- Result:
- MFNS: mean -2.47 versus -1.17 on control; difference -1.30 (95% CI -1.78 to -0.83), standardized effect d = -0.62; z-test p = <0.001.
- Interpretation:
- The 95% confidence interval excludes no difference, so the mean is statistically lower for MFNS than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
The registry posts one secondary endpoint: change from baseline in total nasal symptom score at 1 week. Its group estimates and recalculated comparison follow the same direction as the primary endpoint, with a greater average reduction in the mometasone furoate group than in the placebo group. The sponsor-reported secondary analysis is also an ANCOVA and has p < 0.001. The endpoint-specific figures are recorded with the outcome results.
That overall consistency offers supporting context for the primary result because the secondary endpoint measures the same composite score at an earlier follow-up. It is not an independent confirmation of a different clinical outcome, and it does not establish whether the pattern persists beyond the periods recorded. The secondary comparison is related to the primary one in both measure and participants, so the results should not be treated as wholly separate evidence.
Unadjusted secondary results carry less weight than a prespecified primary analysis when several outcomes or comparisons are examined. As a general statistical point, testing multiple outcomes can increase the chance of finding a low p-value by chance unless the analysis plan addresses multiplicity. The registry record does not report a multiplicity procedure or enough detail to determine how the secondary result was prioritized or interpreted. Its p-value should therefore be read as an unadjusted result, not as evidence that a multiplicity issue was resolved.
The registry lists two outcome measures overall and one posted secondary outcome. The record does not provide a full account of all planned outcomes or indicate whether any outcomes were omitted. The secondary result can be considered alongside the primary result, while recognizing that its inferential strength depends on prespecification and multiplicity details that are not reported in the registry record.
Secondary outcomes registered for this trial, for reference (only those above were recalculated):
- Change From Baseline in the Total Nasal Symptom Score at 1 Week
9. Statistical Interpretation
At 2 weeks, the posted least-squares mean change was -3.985 for mometasone furoate nasal spray and -1.908 for placebo. Both group estimates are negative, indicating reductions in the composite score from baseline. The unadjusted recalculation gives a mean difference of -2.077, with a confidence interval from -2.619 to -1.535 and p < 0.001. Under the stated direction of the comparison, this negative estimate corresponds to a larger average reduction in the mometasone furoate group than in the placebo group.
The confidence interval lies entirely on the negative side of zero, and the unadjusted p-value is below the conventional 0.05 planning significance level. These statistics describe the posted summaries under an unadjusted comparison; they do not establish the clinical importance of the difference. The registry’s sponsor-reported analysis is an ANCOVA with p < 0.001. Its effect estimate and confidence interval are not reported in the registry record, so the registry does not provide those quantities for a direct comparison with the recalculation.
The score’s range and direction help interpret the sign of the result, but the registry record does not specify a threshold that would distinguish a clinically important change from a smaller change. A group-average contrast also does not describe every participant’s experience or the distribution of individual changes. The posted group summaries cannot establish how much participants varied around those averages.
The result concerns the endpoint and follow-up period recorded: total nasal symptom score at 2 weeks or discontinuation. It does not, by itself, describe longer-term outcomes, individual symptoms, or outcomes beyond those posted. The trial’s short treatment period and the absence of detailed analysis-population and missing-data information limit how fully the estimate can be interpreted. The numerical result should therefore be read as a between-group statistical comparison of the recorded score changes, not as a stand-alone judgment about clinical benefit or an individual treatment decision.
10. Statistical Methods Explained
The registry’s reported primary analysis is ANCOVA, with p < 0.001. The registry does not report the model’s effect estimate, confidence interval, covariates, or other implementation details. A separate recalculation uses the posted group summary statistics and is an unadjusted comparison. Those results answer related but not identical statistical questions: ANCOVA can account for variables included in its model, while an unadjusted comparison uses the group summaries without such adjustment.
What does a least-squares mean describe?
A least-squares mean is a model-based group estimate. In an analysis such as ANCOVA, it can represent a group mean adjusted for variables included in the model. The registry labels the group results as least-squares means, but does not report the covariates or enough detail to reconstruct the adjustment. The reported group values should therefore be understood as the registry’s stated estimates, not as independently verified raw averages.
What does the recalculated mean difference describe?
The recalculated mean difference is an unadjusted contrast based on the posted group summaries. For the primary endpoint, the posted difference is -2.077. Its negative sign reflects the ordering of the group estimates and the fact that a more negative change represents a greater reduction in score. The recalculation is not a replacement for the sponsor’s ANCOVA; it offers a transparent comparison based on the available summary statistics.
What does the p-value tell the reader?
A p-value describes how compatible the data are with a specified null comparison under the assumptions of the statistical method. A small p-value is evidence against that null comparison, but it does not measure the size or clinical importance of an effect, and it is not the probability that the null hypothesis is true. The recalculated unadjusted p-value is p < 0.001; the sponsor-reported ANCOVA p-value is p < 0.001. They arise from different analyses, and the registry does not report the sponsor model’s effect estimate or confidence interval.
Why can an adjusted analysis differ from a simple comparison?
As a general statistical point, adjustment can change an estimate or its uncertainty when the model accounts for other variables. Whether and how much that occurs depends on the variables and model used. Those details are not reported in the registry record. The recalculated result should consequently be treated as an unadjusted check of the posted summaries, not as a reproduction of the ANCOVA.
What do standard errors contribute?
A standard error describes the estimated sampling uncertainty of an estimate under the method used. It is not the same as the spread of individual participant outcomes. The registry reports standard errors for the group least-squares means. The recalculation uses posted summary information, including these standard errors, and an approximate pooled standard deviation. Because that standard deviation is approximate, the recalculation has assumptions that should not be confused with the sponsor’s analysis.
Why does over-dispersion matter?
As a general statistical concept, over-dispersion occurs when observed variation is greater than a model assumes. It can make model-based uncertainty too small if not addressed, affecting confidence intervals and tests. The primary endpoint is a continuous score and the record does not report an over-dispersion assessment or a model specification that would establish whether this issue was relevant. It would therefore be inappropriate to claim that over-dispersion was present or that the analysis did or did not account for it.
What is not available for assessing the analysis?
The registry record does not report the analysis population, missing-data method, covariates in the ANCOVA, assumptions checks, treatment of discontinuations, or a detailed statistical analysis plan. It also does not report whether interim analyses were conducted. Those omissions do not change the posted numbers, but they limit independent assessment of how the estimates were generated and how robust they are to analysis choices.
11. Confidence Intervals and Precision
The primary unadjusted recalculation estimates a mean difference of -2.077, with a confidence interval from -2.619 to -1.535. The interval gives a range of values compatible with the data and the assumptions of that calculation. It conveys uncertainty about the estimated contrast rather than a range containing a specified proportion of individual participants’ changes. The confidence level is not stated in the registry record.
Because the full interval is below zero, the unadjusted estimate is statistically separated from a zero difference under the calculation’s assumptions. The interval also shows that the estimated contrast is not a single exact value: the data are compatible with a range of differences. The p-value, p < 0.001, gives a related test result, but does not show the estimate’s clinical importance or explain how much participants’ individual responses varied.
The sponsor’s ANCOVA result is reported as p < 0.001, but an ANCOVA estimate and confidence interval are not reported in the registry record. Its precision therefore cannot be assessed from the posted sponsor result in the same way as the recalculated contrast. The group standard errors are reported, but they are not a substitute for a confidence interval around the sponsor’s adjusted treatment contrast.
Precision also depends on analysis choices and the information available. The recalculation is unadjusted and uses an approximate pooled standard deviation derived from posted summary statistics. The record does not state the confidence level, analysis population, missing-data handling, or model details needed for a fuller assessment. The interval should be read as describing the precision of this simple recalculation, not as resolving those unreported aspects of the trial analysis.
12. Planning a Similar Trial: Sample Size
This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.
| Effect to detect | Participants per arm, 80% power | Participants per arm, 90% power |
|---|---|---|
| 100% of the observed effect | 22 | 29 |
| 75% of the observed effect | 38 | 51 |
| 50% of the observed effect | 85 | 113 |
The planning figures are participants per arm, not total events. They are illustrations based on the observed effect, not the trial’s original design calculations. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each row considers detecting a stated fraction of the observed effect.
The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the selected effect under the planning assumptions, if that effect is truly present. The 90% power column gives the corresponding illustration for a 90% chance. These are design-planning probabilities, not probabilities that the trial result is correct, and not measures of the probability that a treatment works.
The rows for 100%, 75%, and 50% of the observed effect show how the illustrative sample size changes as the target effect becomes smaller. Smaller effects are harder to distinguish from random variation, so they require more participants under otherwise unchanged assumptions. The figures use the observed estimate as their reference, which means the planning exercise depends on an effect estimated from this trial and should not be treated as an independent guarantee of a future result.
This is not observed power. The registry’s original sample-size justification and design assumptions are not reported in the registry record. The planning illustrations do not establish what assumptions investigators used when the trial was designed, nor do they imply that the observed trial had a particular probability of detecting an effect.
13. How the Sample Size Is Derived
Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z1−α/2 = 1.960) and the desired power (z1−β = 0.842 for 80% and 1.282 for 90%).
Formula
n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.
Worked calculation for this trial
- Observed difference Δ = -2.077; pooled standard deviation σ = 2.406.
- n = 2 × (1.96 + 0.842)2 × 2.4062 / -2.0772 = 21.1, rounded up to 22 participants per arm for 80% power.
The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).
R code
alpha <- 0.05
z_a <- qnorm(1 - alpha / 2) # two-sided
delta <- -2.0769 # observed difference in means
sigma <- 2.40585608309557 # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))
# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")
# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1135134)
n <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n)) # difference in sample means
s2 <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1)) # pooled sample variance
tstat <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))
Output from running the code
100% of observed effect: n per arm = 22 (80% power), 29 (90% power)
75% of observed effect: n per arm = 38 (80% power), 51 (90% power)
50% of observed effect: n per arm = 85 (80% power), 113 (90% power)
power.t.test: 22.1
Simulated power at n = 22 per arm: 0.803 (20000 replicates)The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.
14. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| ANCOVA | not reported | < 0.001 |
The registry reports the sponsor’s primary analysis as ANCOVA, with p < 0.001. It does not report the ANCOVA effect estimate, confidence interval, covariates, or other model details. The sponsor’s result therefore communicates a test result but does not, on its own, show the adjusted difference’s magnitude or precision.
The separate recalculation is an unadjusted comparison of posted summary statistics. It estimates a mean difference of -2.077, with a confidence interval from -2.619 to -1.535 and p < 0.001. Because the recalculation is not ANCOVA, it should not be presented as an exact reproduction of the sponsor’s analysis. Differences in method can affect estimates and uncertainty, but the information needed to assess that in this trial is not reported in the registry record.
The registry’s discrepancy indicator is false. Accordingly, there is no recorded discrepancy flag requiring the sponsor’s analysis to take precedence over the recalculation. The two results are best read according to their methods: the sponsor-reported ANCOVA test and the unadjusted recalculation each describe a comparison, with the adjusted estimate and its precision unavailable for the former.
15. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when several statistical questions are tested in the same study. As a general statistical concept, repeated testing can increase the chance of at least one apparently positive result even when there is no true effect for the questions being tested. Common approaches to address this include prespecifying a hierarchy of outcomes or adjusting the testing procedure. The registry record does not report a multiplicity adjustment, testing hierarchy, or detailed plan for interpreting multiple outcomes.
The primary endpoint is change in total nasal symptom score at 2 weeks, and one secondary endpoint at 1 week is posted. The record lists two outcome measures overall. It does not report whether additional outcomes were planned, how the primary and secondary tests were ordered, or whether the secondary p-value was adjusted. The secondary result should therefore be interpreted with the possibility of multiple testing in mind, without assuming that an adjustment was or was not made outside the information in the registry record.
Missing-data handling is also not reported. The registry describes assessments at treatment start and at follow-up or discontinuation, but does not explain how incomplete scores, discontinuations, or unavailable follow-up assessments entered the analyses. The outcome analysis population is not reported in the endpoint description. These gaps matter because estimates can depend on which participants contribute data and on how missing observations are treated.
The record also does not report an interim-analysis plan, stopping rules, or a full statistical analysis plan. It is not possible to infer these details from the reported p-values or from the fact that the study is completed. The limitations concern transparency and independent appraisal; they do not justify assuming that a particular unreported method was used.
16. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| MFNS | 0 | 220 | 0.0% |
| Placebo | 0 | 113 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| MFNS | 24 of 220 |
| Placebo | 19 of 113 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MFNS | Placebo |
|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 13 of 220 | 11 of 113 |
| Naspharyngitis | Infections and infestations | 11 of 220 | 10 of 113 |
The posted serious adverse event figures show 0 reported serious adverse events among 220 participants at risk in the mometasone furoate nasal spray group and 0 among 113 participants at risk in the placebo group. These are the registry’s reported counts for the listed serious adverse event measure. They do not establish that serious adverse events were impossible or that the treatments have identical safety profiles.
A zero count in a trial of this size and duration means no serious adverse events were recorded in the listed groups during the reporting period. It does not rule out uncommon events or events occurring outside the observation period. The registry describes follow-up 30 days after completion or discontinuation to confirm the presence or absence of serious adverse events and trial procedure-related adverse events, but further detail about ascertainment and follow-up completeness is not reported in the registry record.
The record also lists other adverse events affecting 24 participants in the mometasone furoate group and 19 in the placebo group. Those counts are distinct from the serious adverse event counts and should not be combined with them. The registry does not provide enough detail in these summary figures to characterize event types, severity, duration, or causal attribution. These results are descriptive and do not support individual medical advice.
17. What the Result Does, and Does Not, Mean
The posted results describe a greater average reduction in the composite nasal symptom score in the mometasone furoate nasal spray group than in the placebo group over the recorded 2-week endpoint period. The unadjusted recalculated contrast is negative, and its confidence interval is entirely below zero. The sponsor’s reported ANCOVA p-value is also below < 0.001, although the adjusted effect estimate and confidence interval are not reported in the registry record.
These findings do not establish how important the score difference is to children or families. The registry does not report a threshold for clinical importance, and a group average cannot describe every participant’s experience. The composite outcome also does not show whether each of its four symptoms changed in the same way. Nor do the short-term results describe effects beyond the 2-week treatment period or answer questions about longer-term outcomes.
The results do not prove that every participant would have the same response, that an individual outcome can be predicted from the group averages, or that the reported score changes translate into a particular day-to-day experience. The registry’s summary data do not provide the distribution of individual changes or a complete account of missing observations and analysis populations.
The reported comparisons are statistical findings within this randomized, placebo-controlled study. They are not medical advice, and they do not substitute for an assessment of a person’s circumstances. The safety summaries likewise show the recorded event counts rather than ruling out risks. The appropriate interpretation is bounded by the posted endpoints, follow-up, and analysis details, including information that is not reported in the registry record.
18. Why This Trial Matters Statistically
This trial illustrates how a continuous symptom score can be summarized as change from baseline and compared between randomized groups. The score combines four nasal symptoms into a single measure, and its direction makes the sign of a change interpretable: more negative change corresponds to a larger reduction in the recorded score. Presenting group estimates together with a between-group contrast helps distinguish within-group change from the comparative question.
It also shows why the method behind a result matters. The sponsor reports an ANCOVA p-value, while a separate recalculation uses posted summary statistics without adjustment. The p-values are both small, but only the recalculation has a posted effect estimate and confidence interval in the available comparison data. A test result alone does not communicate the magnitude or precision of an adjusted contrast.
The secondary endpoint adds context because it uses the same symptom score at an earlier follow-up, while also raising the general issue of multiplicity. A consistent pattern across related time points can be informative, but it should not be mistaken for independent confirmation when the outcomes and participants are related and the adjustment plan is not reported.
Finally, the record demonstrates the value of separating observed trial results from planning illustrations. Sample-size illustrations based on an observed effect are not the trial’s original design rationale and are not observed power. Distinguishing those quantities, and noting where analysis populations or missing-data procedures are unreported, supports a more careful reading of clinical trial statistics.
19. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record provides limited information about the primary ANCOVA. It reports a p-value but not the adjusted treatment contrast, confidence interval, covariates, or model diagnostics. The unadjusted recalculation is useful as a summary-based comparison, but it cannot fill in those missing details or verify the adjusted analysis.
The analysis population and missing-data procedures are not reported. This is especially relevant because the trial description allows assessment at discontinuation, while the record does not explain how discontinuations or incomplete scores were handled in the endpoint analysis. The registry also does not report whether all randomized participants contributed to the posted endpoint summaries.
The endpoint is a composite score, and the registry provides no clinical-importance threshold. The overall change does not reveal the separate results for sneezing, rhinorrhea, congestion, or itching, nor does it show the variation in individual participant changes. The record reports a short treatment period and an earlier secondary assessment, without establishing longer-term outcomes.
The registry does not report a multiplicity plan, interim-analysis details, original sample-size justification, or complete statistical analysis plan. Such information would help assess prespecification and the interpretation of secondary tests. The masking classification and the study title use different levels of terminology, but the registry does not describe role-specific masking details to clarify them. These limitations do not negate the posted results; they define what can and cannot be inferred from the record.
20. Related Tutorials
21. Related Statistical Calculators
22. Sources
- ClinicalTrials.gov: Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332) — NCT01135134.
- Registry record last updated 2024-05-28; status last verified 2022-02.
- Results first posted 2011-11-03.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
23. Record Summary
This completed phase 3 study randomized pediatric subjects with perennial allergic rhinitis to mometasone furoate nasal spray or placebo. The registry lists enrollment as 333 and describes a 2-week treatment period following an observation period. The primary outcome was change from baseline in total nasal symptom score at 2 weeks; one secondary outcome assessed change at 1 week.
The primary group estimates were -3.985 for mometasone furoate nasal spray and -1.908 for placebo. The unadjusted recalculated mean difference was -2.077, with a confidence interval from -2.619 to -1.535 and p < 0.001. The sponsor-reported ANCOVA result was p < 0.001, without a posted adjusted estimate or confidence interval. Serious adverse event counts were 0 in each group. Analysis populations, missing-data methods, multiplicity handling, and the original sample-size justification are not reported in the registry record.