Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain (NCT01098747), a randomized phase 3 study. The primary outcome is Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8).

2. Clinical Question

3. Trial Design

The registry record describes a completed phase 3, randomized, quadruple-masked, parallel-group trial sponsored by Pfizer. Enrollment is listed as 335. The study began in 2010-04, and primary completion is listed as 2010-07. Its stated aim was to compare the pain-relieving effect of a single dose of a novel ibuprofen formulation with placebo and two formulations of standard ibuprofen for post-surgical dental pain after third-molar removal.

The interventions are listed as one novel ibuprofen intervention, two standard ibuprofen interventions, and placebo. Treatment-arm descriptions are blank. The primary results available for interpretation compare Ibuprofen Sodium with Placebo. Results for other arms are also recorded for a secondary global-evaluation endpoint, but the registry record does not explicitly map those arm labels to the intervention descriptions. That limits how specifically the active formulations can be characterized from these entries.

Randomization supports a comparison of assigned groups, while masking is intended to limit influences on participant responses and outcome assessment. The registry record identifies the design features but does not report details such as the randomization sequence, allocation concealment procedures, masking procedures, or whether masking was maintained. These details should not be inferred from the design labels alone.

The primary endpoint is a continuous, time-weighted measure covering 0 to 8 hours. The listed primary population is intent-to-treat, defined as randomized participants who received study medication and posted a baseline assessment. The record reports an enrollment figure, but does not give a full account of participant flow, exclusions from the endpoint analysis, or missing endpoint values. The trial’s own sample-size justification and original planning assumptions 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

Analysis population for the primary outcome, as defined in the registry: Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.

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.

6. Primary Endpoint

The registry lists the primary outcome as Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8), measured over 0 to 8 hours.

The primary endpoint is the time-weighted sum of pain relief rating and pain intensity difference from 0 to 8 hours, abbreviated SPRID 0-8 in the registry record. It combines two types of patient-reported information: a rating of perceived pain relief and the change in pain intensity from baseline at assessment times. The combined pain-relief and pain-intensity measure is then accumulated over the stated observation period with time weighting. The score range is -8 (worst) to 56 (best).

Using both relief and intensity information can capture aspects of the pain experience that either measure alone may not represent. Weighting over time also makes the endpoint reflect the pattern of scores across the observation window rather than a single assessment. In general, a continuous summary measure can retain information about degrees of response, rather than reducing responses to a simple event/no-event classification.

The registry record defines pain intensity as a scale from 0=none to 3=severe, and notes baseline severity ranged from 2=moderate to 3=severe. Pain intensity difference is baseline severity minus severity at a given assessment; its stated range is -1 (worst) to 3 (best). Pain relief rating uses a five-point scale from 0=No relief to 4=Complete relief. These component definitions clarify how the endpoint is constructed, but the registry record does not provide the detailed schedule of assessments or all rules used to handle missing assessments.

The primary result is a group mean comparison. It therefore describes average accumulated scores, not the experience of every participant, the probability of achieving meaningful relief, or the timing of an individual response.

7. Results Posted in the Registry

• Ibuprofen Sodium: mean 29.80 versus 5.40 on control; difference 24.40 (95% CI 19.49 to 29.31), standardized effect d = 1.72; z-test p = <0.001.

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.

Participant Global Evaluation of Study Medication

• 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 deviations.
• Result:
  • Ibuprofen Sodium: mean 3.80 versus 1.10 on control; difference 2.70 (95% CI 2.28 to 3.12), standardized effect d = 2.43; z-test p = <0.001.
  • Ibuprofen (Advil + Motrin IB): mean 3.70 versus 1.10 on control; difference 2.60 (95% CI 2.19 to 3.01), standardized effect d = 2.13; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Ibuprofen Sodium than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Ibuprofen (Advil + Motrin IB) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry lists secondary outcomes covering pain relief ratings, pain-intensity differences, combined scores, time to perceptible relief, time-weighted summaries, meaningful relief, and a global evaluation of study medication. This range of outcomes provides different views of the pain experience: some summarize ratings or changes in intensity, while others focus on timing or participants’ overall evaluation. They are related to the primary endpoint, but they are not interchangeable measures and need not produce identical estimates.

The detailed secondary summary available for participant global evaluation reports higher mean ratings for the active-treatment groups than for placebo. The reported comparison results include statistically significant contrasts for the listed mean-difference analysis, while another reported proportional-hazards-model result has p=0.667. These entries involve different outcomes or contrasts and should not be treated as a single uniform pattern. The registry record does not provide enough detail to resolve all relationships between each reported analysis and the full list of secondary outcomes.

Secondary results can support context for the primary finding by showing whether other measures tell a broadly compatible story. They cannot, by themselves, substitute for the primary endpoint or establish a result for every outcome on the list. In particular, a global evaluation reflects a different construct from the time-weighted pain score, while a time-to-event analysis concerns timing rather than an average score.

Unadjusted secondary p-values carry less weight when many outcomes and comparisons are examined. In general, testing many hypotheses increases the chance of at least one apparently notable result arising by chance if no multiplicity adjustment is used. The registry record does not report a multiplicity-control procedure for these secondary analyses. Their results are best treated as supportive or exploratory rather than as independent confirmation of a definitive effect across all endpoints.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Time to Confirmed First Perceptible Relief
• Pain Relief Rating (PRR)
• Pain Intensity Difference (PID)
• Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
• Time-weighted Sum of Pain Intensity Difference (SPID)
• Time-weighted Sum of Pain Relief Rating (TOTPAR)
• Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
• Cumulative Percentage of Participants With Meaningful Relief

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous, and the registry record reports a mean and standard deviation for each group. A mean is a measure of the group’s average score. A standard deviation describes how dispersed individual scores are around that average. When participants’ scores vary, the group mean alone does not convey that variability; the standard deviation and confidence interval help give context to the estimate.

The recalculated comparison uses the posted summary statistics to estimate an unadjusted difference in means. “Unadjusted” means that the calculation compares the group summaries without incorporating covariates or other model adjustments. The posted mean difference is 24.4 units, with a 95% confidence interval from 19.49 to 29.31. The unadjusted p-value is <0.001. These are recalculated results, not a replacement for the sponsor’s analysis.

The sponsor reports an analysis of variance, or ANOVA, with a least-square mean difference. In general, ANOVA is a model-based approach for comparing group means. A least-square mean is a model-based estimate, and can differ from the raw group mean contrast when the analysis includes adjustments. The registry record reports the sponsor estimate as 24.21, with a 95% confidence interval from 19.32 to 29.09 and p <0.001. The covariates and other model details are not reported in the registry record. Since the discrepancy indicator is false, there is no flagged disagreement between the posted and recalculated analyses; the estimates nevertheless represent distinct analytical summaries.

A confidence interval gives a range of values compatible with the data under the statistical model and its assumptions. It communicates precision as well as direction: a narrower interval indicates more precise estimation than a wider interval on the same scale. It is not a range containing a known fixed proportion of individual participant scores, and it does not mean that the true effect has a probability of being inside the particular interval. A confidence interval should be read alongside the estimate, scale, and analysis method.

The p-value addresses how compatible the observed data are with a null model of no difference, under the assumptions of the test. A small p-value does not measure clinical importance, prove that the null hypothesis is impossible, or report the chance that the finding occurred randomly. The effect estimate and confidence interval provide more direct information about the magnitude and precision of the group difference.

The reported primary comparison is a mean-based analysis of a continuous outcome. General statistical considerations for continuous endpoints include the distribution of scores, the independence of observations, and the adequacy of the model’s assumptions. The registry record reports means and standard deviations but does not report diagnostic checks, transformations, or alternative analyses for departures from model assumptions. There is no basis in the record to claim that a particular check was performed.

Over-dispersion is a general concern for certain count outcomes when observed variability exceeds what a model assumes. It is not the principal issue for this continuous mean comparison. More generally, a statistical model should reflect the kind of outcome being analyzed and its variability; an analysis appropriate for counts or time-to-event outcomes is not interchangeable with a mean comparison.

The study also lists time-to-event and rating outcomes among its secondary endpoints. In general, time-to-event methods account for the timing of an event and may handle incomplete follow-up differently from a simple comparison of means. The registry record includes a proportional hazards model result for a secondary analysis, but its specific endpoint interpretation should follow the listed outcome and analysis details. The record does not provide enough detail to reconstruct every analysis specification.

Several features of the registry entry constrain interpretation. The primary population is defined as randomized participants who received study medication and provided a baseline assessment; the record does not supply full participant-flow details or missing-data methods. The original statistical analysis plan, multiplicity procedure, and interim-analysis details are not reported in the registry record. Those omissions do not invalidate the reported estimates, but they leave uncertainty about how the full set of planned analyses was handled.

11. Confidence Intervals and Precision

The recalculated primary mean difference is 24.4 units, and its 95% confidence interval extends from 19.49 to 29.31. The interval is entirely above zero, which is consistent with a higher average SPRID 0-8 score for ibuprofen sodium than placebo. The interval expresses uncertainty about the estimated group difference; it does not describe the spread of individual participants’ scores. The group standard deviations, 14.2 for ibuprofen sodium and 14.1 for placebo, describe that within-group spread.

The sponsor’s ANOVA estimate is a least-square mean difference of 24.21, with a 95% confidence interval from 19.32 to 29.09. Its interval also lies above zero and is similar in location and width to the recalculated interval. The two intervals arise from different summaries: an adjusted model result and an unadjusted calculation from posted summary statistics. Their close values support a similar description of this particular contrast, while the sponsor’s model remains the registry’s reported analysis.

Precision is not the same as importance. A confidence interval can help readers judge the range of effect sizes compatible with the data, but it does not determine whether a given difference is meaningful to patients. The registry record supplies the score scale and its direction, but does not report a threshold for a clinically important difference. It is therefore not appropriate to classify the estimate as clinically meaningful on the basis of the interval alone.

The confidence interval also depends on the analysis assumptions and available endpoint data. The registry record does not report the detailed missing-data approach, model covariates, or sensitivity analyses for the primary endpoint. Those gaps matter when assessing how robust the interval is to alternative analysis choices. The interval should be read as precision for the reported comparison under its analysis, not as a guarantee that other populations, outcomes, or treatment contrasts would have the same estimate.

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.

The sample-size figures are planning illustrations derived from the observed effect, not the trial’s own original design calculations. The assumptions listed for these illustrations are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. They show participant counts per arm for the continuous-outcome comparisons, with the effect to detect set as the stated fraction of the observed effect. The note that time-to-event calculations give total events does not change the interpretation of this primary continuous-outcome comparison: its figures are participants per arm.

The 80% power column means the illustrated number of participants per arm for a design with an 80% chance of detecting the assumed effect under the stated statistical assumptions, if that effect is the true effect. The 90% power column expresses the corresponding planning target for a 90% chance. These are design concepts, not probabilities that the trial result is correct or that an individual participant will benefit. The displayed figures are planning illustrations and are not observed power.

The rows that plan for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect use progressively smaller assumed effects. Smaller effects are harder to distinguish from random variation, so they require more participants per arm to reach the same power target. The figures should be interpreted as conditional illustrations rather than recommendations or proof that the trial had adequate planned power.

The registry record does not report the trial’s original sample-size justification, the effect size used in that justification, or its planned power target. Therefore, these retrospective illustrations cannot establish what the sponsor planned before enrollment or whether the actual trial met that plan. They also should not be mistaken for observed participant counts in the endpoint analysis; those counts are reported separately with the outcome results.

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 z_1−α/2 = 1.960) and the desired power (z_1−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

1. Observed difference Δ = 24.400; pooled standard deviation σ = 14.167.
2. n = 2 × (1.96 + 0.842)² × 14.167² / 24.400² = 5.3, rounded up to 6 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 <- 24.4                      # observed difference in means
sigma <- 14.1667450978221                     # 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(1098747)
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 = 6 (80% power), 8 (90% power)
 75% of observed effect: n per arm = 10 (80% power), 13 (90% power)
 50% of observed effect: n per arm = 22 (80% power), 29 (90% power)
power.t.test: 6.4 
Simulated power at n = 6 per arm: 0.769 (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

The sponsor’s reported primary analysis is an analysis of variance comparing the placebo and ibuprofen sodium groups. It gives a least-square mean difference of 24.21, with a 95% confidence interval from 19.32 to 29.09 and p <0.001. This is the registry’s own model-based result and should be distinguished from the recalculated unadjusted contrast based directly on the posted group means and standard deviations.

The recalculation gives a mean difference of 24.4, with a 95% confidence interval from 19.49 to 29.31 and an unadjusted p-value <0.001. The estimates are similar, but the calculations do not represent identical estimands: one is a reported least-square mean difference from ANOVA, and the other is an unadjusted difference of posted averages. The registry record does not give enough model detail to explain every element of the sponsor’s adjustment.

The discrepancy flag is false, so the record does not identify a material discrepancy requiring the recalculation to displace the sponsor result. The sponsor’s analysis remains the primary record-reported analysis; the recalculation serves as a transparent comparison based on the posted summaries. Both analyses point to a positive mean difference for the specified endpoint and comparison, but neither should be extended beyond that scope.

15. Multiplicity, Missing Data and Analysis Populations

The record lists many outcome measures and analyses, including secondary measures of pain ratings, pain intensity, combined scores, relief timing, meaningful relief, and global evaluation. When a study evaluates multiple outcomes or comparisons, multiplicity is a statistical concern: the chance of false-positive findings can increase across the collection of tests. General approaches include prespecifying a testing hierarchy or adjusting inference to account for multiple comparisons. Which approach is appropriate depends on the study’s goals and analysis plan.

The registry record does not report whether the primary and secondary hypotheses were arranged in a hierarchy, whether any multiplicity adjustment was planned, or which results were intended to support confirmatory claims. The analysis plan is not reported in the registry record. Consequently, the primary result can be described as reported, but the secondary p-values should not be read as if every comparison had been protected from the effects of multiple testing.

The primary population is described as intent-to-treat participants who were randomized, received study medication, and provided a baseline assessment. This definition is specific and should not be broadened to all randomized participants regardless of treatment receipt or baseline availability. The registry record does not report a detailed participant-flow accounting for the primary endpoint, the number of endpoint values missing, or the reasons for missingness.

Missing outcome data can affect a group comparison if the availability of measurements is related to treatment or outcome. Statistical methods for missing data make assumptions about why values are absent and how unobserved outcomes relate to observed information. The record does not report the primary endpoint’s missing-data method, sensitivity analyses, or assumptions. It is therefore not possible to assess from this entry whether alternative missing-data assumptions would materially change the estimate.

Interim analyses, stopping rules, and the original sample-size justification are also not reported in the registry record. Their absence should be treated as missing reporting information, not evidence that such procedures were or were not used. The limitations affect how fully the analysis can be audited, while leaving the reported numerical results available for interpretation within their stated scope.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists serious adverse events for the safety groups at risk. It reports zero serious adverse events among 48 participants at risk in the placebo group and zero among 95 at risk in the ibuprofen sodium group. The other listed active groups also have zero serious adverse events: 86 at risk for Ibuprofen (Advil) and 87 at risk for Ibuprofen (Motrin IB). No serious adverse-event terms are listed. Death counts are not reported in the registry record.

These figures describe reported serious adverse events during the registry’s specified safety accounting; the record does not give the relevant observation window or detailed event definitions in the information. A zero count means no such events were recorded in the listed group, not that the possibility of serious harm is excluded. Safety interpretation depends on the number of participants observed, duration of observation, event ascertainment, and completeness of reporting.

The registry also lists other adverse events affecting 8 placebo participants, 10 Ibuprofen Sodium participants, 12 Ibuprofen (Advil) participants, and 10 Ibuprofen (Motrin IB) participants. These are separate from serious adverse events. Counts alone do not establish that an event was caused by study medication, and the record’s aggregate figures do not describe the nature or severity of each non-serious event.

17. What the Result Does, and Does Not, Mean

The posted primary comparison shows a higher mean time-weighted pain-relief and pain-intensity score for ibuprofen sodium than placebo over 0 to 8 hours after third-molar surgery. The estimated unadjusted difference is 24.4 units, and the sponsor’s ANOVA reports a least-square mean difference of 24.21. Both reported intervals are above zero, and both analyses report p-values <0.001. These findings describe group averages for the specified endpoint and comparison.

The result does not say that every participant experienced the same degree of relief, nor does it estimate the probability that a particular participant will have a particular response. A mean difference can coexist with substantial variation among individual scores, as the posted standard deviations indicate. The outcome combines pain relief ratings and changes in pain intensity; it is not a direct measurement of every aspect of recovery or functioning.

The comparison should not be generalized automatically to the standard ibuprofen formulations, because the primary result described is ibuprofen sodium versus placebo. The registry’s stated study purpose includes standard formulations, but the arm descriptions are blank and the primary posted comparison does not provide the same estimate for every formulation. Secondary outcomes also measure different aspects of pain and carry the additional interpretive concern of multiple testing.

The result is limited to the 0-to-8-hour endpoint and the post-surgical dental-pain setting described in the record. Longer-term outcomes, repeated dosing, and other clinical settings are not reported in the registry record. Statistical evidence for a group difference is not itself a determination of clinical importance; the registry does not report a threshold for a clinically important SPRID difference. The findings therefore support a focused interpretation of the recorded comparison, not a broader claim about all outcomes or circumstances.

18. Why This Trial Matters Statistically

This trial illustrates why the outcome definition matters. SPRID 0-8 is not a single pain rating: it combines reported relief with change in pain intensity and accumulates that combined information over a specified period. A reader interpreting the mean difference needs the scale direction and construction to understand what a higher score represents. The registry’s component definitions make the endpoint more interpretable, while the missing assessment schedule and some analysis details limit full reconstruction.

It also demonstrates the distinction between a sponsor-reported model result and a recalculation from group summaries. The reported least-square mean difference and the unadjusted difference in means are similar, but they arise from different methods. Clear separation of these estimates helps avoid treating a model-based adjusted contrast as if it were simply the difference between raw means. Confidence intervals add information about precision that a p-value alone does not convey.

The secondary outcomes raise a further statistical issue. A trial can examine several related measures, and their results may not be independent or equally confirmatory. Without a reported multiplicity plan, isolated secondary p-values deserve cautious interpretation. The record’s missing information on missing-data methods and the original sample-size justification also shows why numerical results are only part of the evidence needed to assess a trial.

Finally, safety counts need to be read in context. No serious adverse events are listed in the reported groups, but the registry entry does not make a zero count proof of no risk. Statistical interpretation requires attention to outcome definitions, analysis populations, uncertainty, and reporting completeness—not just whether a p-value crosses a threshold.

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 primary result is reported for Ibuprofen Sodium versus Placebo, while the study’s stated aim also includes a novel formulation and two standard ibuprofen formulations. The registry lists intervention names but leaves treatment-arm descriptions blank. As a result, the mapping between the study’s intended formulation comparisons and all posted arm labels is not fully documented in the registry record. The primary estimate should be kept to the named comparison rather than assigned to an intervention label without qualification.

The endpoint combines ratings over 0 to 8 hours, but the registry record does not report the full assessment schedule, the detailed data-derivation rules, or how missing assessments were handled. It also does not give the covariates or other specifications for the sponsor’s ANOVA. Those omissions prevent a complete independent reconstruction of the reported model-based result.

The primary population definition excludes randomized participants who did not receive study medication or did not provide a baseline assessment. The record does not provide detailed participant flow or endpoint-specific missingness. The available summaries therefore do not establish how exclusions or missing values may have affected the analysis.

There are numerous listed outcome measures and analyses, but a multiplicity strategy is not reported in the registry record. Secondary findings, including outcomes with different measurement scales and methods, should be interpreted cautiously rather than treated as a set of independent confirmations. The original sample-size justification, interim-analysis details, and statistical analysis plan are also not reported, so the retrospective planning illustrations cannot fill those gaps.

Finally, the registry reports a short observation period for the primary endpoint and does not provide longer-term results in the information available for this analysis. The findings therefore have a limited outcome and setting scope. These reporting limitations do not change the posted estimates, but they constrain how completely their assumptions, robustness, and broader relevance can be assessed.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain — NCT01098747.
• Registry record last updated 2012-08-17; status last verified 2012-07.
• Results first posted 2012-08-17.
• 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.

23. Record Summary

NCT01098747 is a completed phase 3, randomized, quadruple-masked, parallel-group trial sponsored by Pfizer. It enrolled 335 participants and studied post-surgical dental pain following third-molar removal. The primary endpoint was the time-weighted sum of pain relief rating and pain intensity difference from 0 to 8 hours.

The primary posted comparison is Ibuprofen Sodium versus Placebo. The recalculated unadjusted mean difference was 24.4 units, with a 95% confidence interval from 19.49 to 29.31 and p <0.001. The sponsor reported an ANOVA least-square mean difference of 24.21, with a 95% confidence interval from 19.32 to 29.09 and p <0.001.

The registry lists secondary pain and global-evaluation outcomes. Serious adverse-event counts were zero in each listed group; death counts are not reported in the registry record. The original sample-size rationale, multiplicity plan, missing-data methods, and detailed analysis specifications are not reported in the registry record.