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 Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013) (NCT03855189), a randomized phase 3 study. The primary outcome is Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03855189 |
| Phase | Phase 3 |
| Condition | Seasonal Allergic Rhinitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 345 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Organon and Co |
| Results posted | Yes |
2. Clinical Question
Population
Participants with seasonal allergic rhinitis who met the trial’s eligibility and evaluability criteria. For the primary outcome, the stated analysis population also required at least one valid post-baseline visit and available diary data. The registry record does not report further clinical or demographic details about this population.
Intervention
Mometasone furoate (MF), given as 200 mcg nasally in the morning and placebo approximately 12 hours later in the evening, for a total daily dose of 200 mcg over 29 days.
Comparator
Beclomethasone dipropionate (BDP), given as 168 mcg nasally in the morning and another 168 mcg approximately 12 hours later in the evening, for a total daily dose of 336 mcg over 29 days; or nasal placebo in the morning and evening over 29 days.
Primary question
How did participant-evaluated total nasal symptom scores change from baseline, on average over Days 1 to 15, in the MF, BDP, and placebo arms? The registry record does not report the numerical arm results or a statistical comparison for this endpoint.
3. Trial Design
The registry identifies this as a phase 3, randomized, triple-masked, parallel-group trial of treatments for seasonal allergic rhinitis. Its listed interventions were MF, BDP, and placebo. The enrollment field reports 345 participants. The record lists the study start as 1993-08-23 and primary completion as 1993-10-08, with status recorded as completed. The sponsor is Organon and Co.
The treatment descriptions specify nasal administration in the morning and again approximately 12 hours later in the evening. MF was given at 200 mcg in the morning, with evening placebo, for a 200 mcg total daily dose. BDP was given at 168 mcg in both the morning and evening, for a 336 mcg total daily dose. The placebo group received nasal placebo at both dosing times. Each regimen is described as lasting 29 days.
Random allocation and a parallel-group structure indicate that participants were assigned to treatment groups that were followed as separate arms. The record labels masking as triple but does not say which groups of people were masked or explain how masking was maintained. It does not report the randomization procedure, allocation concealment, group-specific randomized counts, or the protocol’s reasons for choosing these doses and treatment duration.
The trial’s stated objective was to assess safety and efficacy of a four-week course of MF compared with BDP or placebo. The listed primary outcome focuses on participant diary scores averaged over Days 1 to 15, while listed secondary outcomes include physician-evaluated symptom scores at several visits and physician-evaluated overall condition at some visits. The registry record does not give numerical results for the primary endpoint. It also does not report numerical results for the listed secondary outcomes in the registry record for this account.
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 | Mometasone Furoate (MF) | Beclomethasone Dipropionate (BDP) | Placebo |
|---|---|---|---|
| STARTED | 113 | 116 | 116 |
| Treated | 112 | 116 | 116 |
| COMPLETED | 103 | 109 | 110 |
| NOT COMPLETED | 10 | 7 | 6 |
Reasons for not completing this period:
| Reason | Mometasone Furoate (MF) | Beclomethasone Dipropionate (BDP) | Placebo |
|---|---|---|---|
| Adverse Event | 5 | 2 | 4 |
| Treatment Failure | 1 | 1 | 2 |
| Noncompliance with Protocol | 0 | 1 | 0 |
| Did Not Return | 4 | 3 | 0 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available diary data.
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 | Mometasone Furoate (MF) | Beclomethasone Dipropionate (BDP) | Placebo | Total |
|---|---|---|---|---|---|
| Participants analysed | 113 | 116 | 116 | 345 | |
| Age, Continuous | Years | 34.8 (SD 12.3) | 34.6 (SD 12.1) | 35.5 (SD 11.2) | 34.9 (SD 11.8) |
| Sex: Female, Male: Female | Participants | 52 | 52 | 72 | 176 |
| Sex: Female, Male: Male | Participants | 61 | 64 | 44 | 169 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated), measured over Baseline, and Days 1 through 15 (average of 15 days of treatment).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in the total nasal symptom score (TNSS), using participant evaluations averaged over Days 1 to 15. Participants recorded four symptoms—rhinorrhea, stuffiness, sneezing, and itching—in morning and evening diaries. Each symptom was scored from 0 to 3, with higher scores representing more frequent or severe symptoms. The four symptom scores were summed to form a TNSS ranging from 0 to 12.
For the treatment interval, daily diary scores were averaged across Days 1 to 15, with morning and evening values computed separately and then averaged. The baseline was the average of morning and evening diary scores from 3 consecutive days before the baseline visit. Change was defined as the post-treatment average minus the baseline average. Thus, a negative change indicates a decrease in symptom severity from baseline; it does not by itself establish how the change compares with another arm.
A symptom score is useful because it turns participants’ recorded experience of several nasal symptoms into a continuous measure that can be compared across treatment groups. The registry describes the endpoint as a mean change, with standard deviation as the dispersion measure. However, it does not report the arm means, standard deviations, uncertainty intervals, or a test result for this outcome. The direction and precision of the observed arm differences therefore cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives the endpoint definition and study design, but it does not report the primary endpoint’s numerical results. There are no arm-specific mean changes or standard deviations in the registry record for this interpretation, and no reported confidence interval or p-value for the primary comparison. Consequently, the magnitude, direction, and statistical precision of any difference between MF, BDP, and placebo cannot be described from this record.
The endpoint is a mean change in a continuous score. Its direction is defined: negative change means lower symptom severity relative to baseline. That definition helps interpret a result if numerical values are available, but it is not itself evidence that a particular arm had a larger or smaller change. Nor does a change within an arm establish how that arm compared with another; a comparative question requires arm-level estimates and an appropriate between-arm analysis.
The trial was randomized, which is a design feature intended to support comparisons between assigned groups. Randomization alone does not provide the missing outcome estimates, and the registry record does not describe the randomization method, allocation concealment, or details of the analysis. Its label of triple masking also does not identify who was masked. These design details would help readers assess potential sources of bias, but they cannot be inferred from the labels alone.
The primary outcome population was defined as randomized participants who met eligibility and evaluability criteria, completed at least one valid post-baseline visit, and had available diary data. This is narrower than a statement that every randomized participant contributed to the primary endpoint. The record does not report how many participants met those requirements, how missing diary information was handled, or whether analyses used another population as a sensitivity check. These omissions limit assessment of how complete and robust the outcome analysis was.
The adverse-event summary reports no serious adverse events in the listed arms and no deaths. It also reports counts of participants affected by other adverse events. These safety counts should be read as descriptive summaries, not as estimates of comparative risk or proof that events were or were not caused by a treatment. The registry record does not provide event types, severity details, exposure-adjusted analyses, or inferential comparisons in the registry record.
Any sample-size values in a planning illustration should be understood as hypothetical planning quantities derived from an observed effect under stated assumptions, not as the trial’s observed power. In this case, the registry entries describe assumptions for such an illustration but do not include calculated sample-size values or an observed primary effect. The registry record does not report a protocol sample-size justification. Without the primary outcome estimates and fuller analysis details, no conclusion about efficacy, equivalence, or the absence of a clinically meaningful difference is supported by this record alone.
9. Statistical Methods Explained
The primary measure is continuous: it is a numerical score formed from participants’ ratings of nasal symptoms. For a continuous outcome, an arm mean describes the average observed score change among participants included in the analysis. A standard deviation describes how spread out individual changes are around that mean. These are different summaries: the mean concerns the average change, while the standard deviation concerns variation among participants.
Change from baseline is calculated by subtracting the baseline average from the post-baseline average. In this trial’s definition, a negative value indicates that symptom severity decreased relative to baseline. A mean change is not the same as a comparison between arms. To estimate a treatment contrast, an analysis must compare the arm-specific outcomes using a stated method. The registry record does not report the primary arm means, standard deviations, estimated contrasts, or the method used to test the primary comparison.
A confidence interval, in general, expresses the uncertainty around an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while an interval spanning a null value may be compatible with multiple possible effects. The registry entries available for this trial do not report a confidence interval for the primary endpoint. Therefore, neither the precision of an estimated treatment contrast nor the range of effects compatible with the data can be evaluated from the record.
A p-value, in general, quantifies how incompatible the observed data are with a specified null model, assuming that model and the analysis assumptions apply. It does not measure the size or clinical importance of an effect. No primary endpoint p-value is reported in the registry record for this account. A p-value alone, even if reported, would not replace the arm estimates, uncertainty intervals, and assessment of the score’s meaning.
The record describes the endpoint’s baseline and post-baseline construction in detail. Morning and evening diary scores were handled separately before being averaged for the interval. This definition matters because an outcome’s summary depends on how observations across symptoms and times are combined. The score’s stated range is 0-12, and higher scores indicate more frequent or severe symptoms. The record does not report the distribution of scores or whether assumptions used in any particular statistical model were checked.
For continuous outcomes, common analyses may compare group means or model repeated measurements, but the specific model used in this trial is not reported in the registry record. It would therefore be inappropriate to assert that the primary analysis used a particular model, adjustment set, or repeated-measures approach. The trial’s randomized, parallel design describes assignment and follow-up structure; it does not, on its own, identify the statistical model used to analyze outcomes.
General statistical context: if outcome variability differs across groups or is greater than a model expects, uncertainty estimates and tests can be affected. In count data, over-dispersion means that variation exceeds the level assumed by a simple count model; that concept does not directly describe this continuous TNSS endpoint, and the record does not report evidence of over-dispersion or any model diagnostic. For continuous outcomes, the relevant questions include the distribution of the scores, the fit of the chosen model, and whether the uncertainty calculation reflects the design and observed variability. The registry does not provide these diagnostics.
The sample-size assumptions describe a planning illustration based on an observed effect, two-sided significance level 0.05, equal allocation between two arms, and a normal approximation; the target effect is a stated fraction of the observed effect. Those assumptions do not establish that they were used to design this trial. No calculated sample-size illustration values are present in the registry record for this account, and the protocol’s sample-size justification is not reported in the registry record. A planning calculation is not observed power: it cannot show the probability that the completed study detected an effect that was truly present.
In general, multiplicity arises when several outcomes, time points, or comparisons are tested, because repeated testing can increase the chance of at least one apparently notable result under a null hypothesis. This trial lists 28 outcome measures and 78 analyses, and the primary endpoint is designated as the average over Days 1 to 15. The record does not report a multiplicity adjustment or a prespecified hierarchy for interpreting tests. A reader cannot determine from the listed counts alone which analyses were confirmatory, which were exploratory, or how conclusions accounted for multiple testing.
These methodological concepts describe what information is useful when reading a trial analysis; they do not fill gaps in the registry record. For this trial, the primary endpoint’s numeric estimates, uncertainty, analysis model, missing-data procedures, and multiplicity strategy are not reported in the registry record for this account.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 28 outcome measures and 78 analyses. It identifies a primary endpoint and lists secondary outcomes, including physician-evaluated TNSS change at Day 4, Day 8, Day 15, Day 22, and Day 29, and physician-evaluated overall condition at some visits. Multiple outcomes, time points, and comparisons can create multiplicity: the more analyses considered, the more important it is to know which questions were prespecified and how the results were interpreted together.
The registry record does not report whether statistical tests were adjusted for multiplicity, whether a testing hierarchy was used, or which analyses were designated confirmatory versus exploratory beyond the primary outcome label. The listed number of analyses does not reveal how many tests were performed for a particular hypothesis or what decision rules were applied.
The primary analysis population is described as randomized participants who met eligibility and evaluability criteria, completed at least one valid post-baseline visit, and had available diary data. The record does not report the number meeting these criteria, the handling of missing diary entries, or whether participants with incomplete follow-up were included in another analysis. It also does not state whether missing values were imputed, omitted, or handled using a model-based procedure. These details are important because missing outcome data can affect both the estimate and its uncertainty.
The registry entries do not report an intention-to-treat analysis, a per-protocol analysis, sensitivity analyses for missing data, or reasons for missing observations. The named primary population should therefore be understood as the registry’s stated analysis population, not as evidence of a particular analysis strategy beyond that description. The registry record also does not report an analysis plan that would clarify how the many outcomes and analyses were to be handled.
11. 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 |
|---|---|---|---|
| Mometasone Furoate (MF) | 0 | 112 | 0.0% |
| Beclomethasone Dipropionate (BDP) | 0 | 116 | 0.0% |
| Placebo | 0 | 116 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Mometasone Furoate (MF) | 0 of 112 |
| Beclomethasone Dipropionate (BDP) | 0 of 116 |
| Placebo | 0 of 116 |
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 |
|---|---|
| Mometasone Furoate (MF) | 47 of 112 |
| Beclomethasone Dipropionate (BDP) | 38 of 116 |
| Placebo | 53 of 116 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Mometasone Furoate (MF) | Beclomethasone Dipropionate (BDP) | Placebo |
|---|---|---|---|---|
| HEADACHE | Nervous system disorders | 29 of 112 | 27 of 116 | 30 of 116 |
| SINUS HEADACHE | Nervous system disorders | 11 of 112 | 6 of 116 | 6 of 116 |
| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | 4 of 112 | 6 of 116 | 12 of 116 |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | 7 of 112 | 6 of 116 | 6 of 116 |
| NASOPHARYNGITIS | Infections and infestations | 4 of 112 | 3 of 116 | 6 of 116 |
| SNEEZING | Respiratory, thoracic and mediastinal disorders | 0 of 112 | 1 of 116 | 8 of 116 |
The adverse-event summary lists three arms. For MF, 112 participants were at risk for serious adverse events and 0 were affected; 112 were at risk for other adverse events and 47 were affected. For BDP, the corresponding figures are 116 at risk and 0 affected for serious adverse events, and 116 at risk and 38 affected for other adverse events. For placebo, 116 were at risk and 0 were affected for serious adverse events, and 116 were at risk and 53 were affected for other adverse events. The record reports 0 deaths in each arm.
These are registry counts, not adjusted comparisons. The “other adverse events” counts are separate from the serious-event counts in the summary and do not, by themselves, describe event type, severity, duration, or whether an event was judged treatment-related. Participants affected is a participant count, not necessarily a count of all events experienced. The registry record does not provide further event-level detail in the registry record for this account.
No serious adverse events or deaths are listed in these arm summaries. That observation should not be read as proof that a treatment has no serious risks. The record does not report the duration of safety follow-up beyond the treatment descriptions, confidence intervals, or a formal comparative safety analysis. The counts describe what the registry reports for the listed groups, and their interpretation is limited by the detail available.
12. What the Result Does, and Does Not, Mean
This record is useful for understanding the study question and how the primary symptom measure was defined. It describes a randomized, triple-masked, parallel-group comparison of MF, BDP, and placebo in seasonal allergic rhinitis. It specifies the nasal regimens and identifies participant-rated TNSS change averaged over Days 1 to 15 as the primary endpoint. It also defines the score’s symptoms, scale, baseline, and direction of change.
However, the registry entries available do not include primary endpoint results. There are no arm-level mean changes, standard deviations, treatment contrasts, confidence intervals, or p-values. As a result, the record does not allow readers to determine the observed direction or magnitude of the primary outcome differences, or how precisely those differences were estimated. The absence of reported numerical results is not evidence of no effect, and it does not establish that the groups had equivalent outcomes.
The listed adverse-event counts provide limited descriptive safety information: no serious adverse events and no deaths are recorded in the arm summaries, while counts for other adverse events are reported. Those figures do not identify individual event types or establish causation, and the record does not provide a formal comparative safety analysis in the registry record.
The design labels and outcome definitions do not resolve other uncertainties. The registry record does not report who was masked, the randomization procedure, the primary analysis model, how missing data were handled, or whether multiplicity was addressed. Nor does it report a protocol sample-size justification. These are meaningful limits on judging bias, precision, and the robustness of any findings.
Accordingly, this trial record supports a description of the intended comparison and selected design and safety details, but not a conclusion about whether one treatment produced greater symptom improvement or a different safety profile. Such conclusions require outcome estimates and analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
Clinical trial interpretation depends not only on identifying treatment groups but also on defining what was measured, when it was measured, and how the score was constructed. This record gives a relatively detailed description of its primary symptom endpoint: participants recorded four nasal symptoms in morning and evening diaries, the symptoms were summed into TNSS, and change was calculated against a baseline average. That clarity helps readers understand what a reported mean change would represent.
The design also makes several comparisons relevant: MF against BDP and placebo, alongside listed secondary symptom and overall-condition outcomes at specified visits. With multiple outcomes and analyses, prespecification and multiplicity handling matter for distinguishing a primary test from additional analyses. The record lists 28 outcome measures and 78 analyses but does not report the strategy used to interpret them together. This illustrates why a registry’s analysis details are important alongside its outcome list.
The trial also shows why result availability matters. A detailed endpoint definition cannot substitute for arm-level estimates and uncertainty. Without those numerical results, readers cannot assess the observed effect’s size or precision, regardless of the randomized design. Likewise, descriptive adverse-event counts can document what was recorded but do not by themselves establish comparative safety.
For statistical readers, the key lesson is to separate three things: the design, the measurement definition, and the numerical evidence. The record describes the first two in part, while the primary numerical evidence and several analysis decisions are not reported. Keeping those categories distinct prevents a protocol description or an absence of posted results from being mistaken for an outcome finding.
14. 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 principal limitation for interpreting this trial is that the registry record does not report numerical results for the primary endpoint. Arm means, standard deviations, comparisons, confidence intervals, and p-values are not included in the registry record for this account. This prevents assessment of the observed effect’s direction, magnitude, and precision.
The primary outcome population is restricted by eligibility and evaluability criteria, at least one valid post-baseline visit, and available diary data. The record does not state how many participants qualified for this analysis or how missing diary observations were handled. It does not report whether the primary result was evaluated in other analysis populations or checked in sensitivity analyses.
Other design and analysis details are also absent. Although the trial is labeled randomized and triple-masked, the randomization method, allocation concealment, and identities of those masked are not reported. The statistical model, treatment of multiplicity across 28 outcomes and 78 analyses, and sample-size justification are not reported in the registry record. These gaps make it difficult to evaluate the planned analysis and the robustness of any result.
The safety summary is limited to participant counts for serious and other adverse events and deaths. It does not provide event descriptions, severity, relatedness, timing, or a formal comparison. The record’s stated treatment duration is 29 days, but the registry entries do not give further safety follow-up details. These limitations mean that the posted safety counts should be interpreted as a narrow summary rather than a complete characterization of harms.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013) — NCT03855189.
- Registry record last updated 2022-02-09; status last verified 2022-02.
- Results first posted 2019-08-09.
- 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.
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18. Record Summary
The registry record describes a completed phase 3 randomized, triple-masked, parallel-group trial sponsored by Organon and Co. It lists 345 participants enrolled and compares nasal MF, BDP, and placebo for seasonal allergic rhinitis. The treatment descriptions specify morning and evening dosing over 29 days.
The primary outcome is participant-evaluated change in TNSS averaged over Days 1 to 15. The score combines ratings of rhinorrhea, stuffiness, sneezing, and itching; negative change indicates decreased symptom severity relative to baseline. The record also lists physician-evaluated secondary outcomes and reports adverse-event counts by arm, with 0 serious adverse events and 0 deaths listed in each arm.
Numerical primary outcome results, the analysis model, missing-data handling, and multiplicity procedures are not reported in the registry record. The available information therefore describes the study and outcome definitions but does not support a numerical assessment of comparative symptom effects.