Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief (NCT01957215), a randomized phase 4 study. The primary outcome is Sum of Pain Intensity Difference (SPID)1-3 Days.

2. Clinical Question

3. Trial Design

This was a Phase 4, randomized, double-masked, parallel-group trial comparing an indomethacin patch with a placebo patch in people with ankle sprain. The registry lists enrollment of 270 participants. The primary outcome data list 135 participants in each arm. The study status is completed; the record gives a start date of 2013-10 and a primary completion date of 2014-09.

The indomethacin patch and placebo patch were each to be applied to the sprained ankle twice a day. The registry identifies GlaxoSmithKline as the sponsor. It describes the study as investigating pain relief in adult patients with ankle sprain, with the placebo patch serving as the comparator.

The primary endpoint was continuous: a score representing the sum of pain-intensity differences over the period from baseline on Day 1 to Day 3. The record describes the primary analysis population as the Intent-to-Treat population, defined as participants who received treatment and had at least one post-baseline efficacy measurement. It does not report further detail about exclusions or the number of participants who did not meet that definition.

The registry lists 12 outcome measures and 11 posted secondary outcomes. The sponsor’s reported primary analysis used ANCOVA and reported an adjusted mean difference. The registry does not report the covariates included in that model, the randomization procedure, the exact masking procedures, or the original sample-size justification. Those design details should not be inferred from the trial’s posted outcome results.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Efficacy analysis was conducted on the Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement

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 Sum of Pain Intensity Difference (SPID)1-3 Days, measured over Baseline (Day 1) to Day 3.

The primary endpoint was Sum of Pain Intensity Difference, or SPID, from baseline on Day 1 to Day 3. It combines pain-intensity differences measured at several time points, weighting each difference by the interval since the preceding measurement. In general, a time-weighted summary can represent the pattern of change across a period rather than relying on a single pain assessment. The registry states that positive and higher SPID scores indicate greater reduction in pain.

Pain intensity was assessed using a numerical rating scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. The endpoint calculation used assessments at baseline and at the listed post-baseline time points through 48 hours. The registry gives the SPID calculation as the sum of each pain-intensity difference multiplied by the time interval between consecutive assessments.

SPID is used as a summary measure because it incorporates both the magnitude and timing of measured pain-intensity changes over the endpoint period. It is a continuous outcome, so the reported group summaries and mean difference describe average scores rather than counts of participants meeting a threshold. The registry does not report a threshold for interpreting an individual score or a minimum clinically important difference. Therefore, statistical differences in mean SPID should not be treated as a direct measure of how many individuals experienced a particular degree of relief.

7. Results Posted in the Registry

• Indomethacin Patch: mean 3.98 versus 3.26 on control; difference 0.72 (95% CI 0.12 to 1.32), standardized effect d = 0.29; z-test p = 0.019.

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.

Change From Baseline in NRS at Rest

• 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:
  • Indomethacin Patch: mean -3.58 versus -3.19 on control; difference -0.39 (95% CI -0.73 to -0.04), standardized effect d = -0.27; z-test p = 0.029.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Indomethacin Patch than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Patients' Global Assessment to Treatment

• 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:
  • Indomethacin Patch: mean 2.70 versus 2.20 on control; difference 0.50 (95% CI -1.23 to 2.23), standardized effect d = 0.07; z-test p = 0.571.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Indomethacin Patch and the control. The interval gives the range of effects that remain compatible with the data.

Rate of Rescue Medication Use

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Indomethacin Patch: 3.0% (4/135) versus 5.2% (7/135) on control; risk difference -2.2 percentage points (95% CI -6.9 to 2.5), risk ratio 0.57 (0.17–1.91); unadjusted two-proportion z-test p = 0.356.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Indomethacin Patch and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes address different aspects of pain, treatment experience, and rescue medication use. Across the outcomes with numerical comparisons, the pattern is mixed: the change-from-baseline NRS comparison is in a direction favoring the indomethacin arm, while the global-assessment and rescue-medication comparisons are more uncertain. The registry also lists pain relief over time, pain on movement, time to onset of relief, and other summary measures, but numerical findings for those outcomes are not reported in the registry record in the analysis data.

These outcomes provide context for the primary SPID result, but they are not interchangeable with it. SPID summarizes time-weighted pain-intensity differences through Day 3, whereas other measures use different scales, time frames, or event definitions. Agreement across related measures could strengthen coherence, while differing results may reflect measurement differences or statistical uncertainty. The posted secondary results do not support treating every measure as a confirmation of the primary finding.

The secondary recalculations use unadjusted comparisons, and the registry does not report a multiplicity adjustment. In general, multiple testing increases the possibility of a nominally notable result arising among many comparisons. This makes isolated secondary p-values less persuasive than a result from a clearly specified primary analysis, particularly when the registry does not describe a testing hierarchy or family-wise error approach. The secondary findings should therefore be viewed as supportive or exploratory evidence rather than as independent definitive tests.

The registry lists 11 secondary outcomes, but not all have detailed numerical results in the record. Their absence from the numerical comparisons should not be interpreted as evidence of no effect or as evidence that the outcomes were not assessed. Results and analysis details not posted in the registry record cannot be inferred from the reported secondary measures.

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

• Pain Relief Score (PRS) on Movement Over Time
• NRS for Pain on Movement Over Time
• Change From Baseline in NRS at Rest
• Time to Onset of Pain Relief
• Assessment of Sum of Pain Intensity Difference (SPID) on Movement
• Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement
• Total Pain Relief (TOTPAR) on Movement
• Patients' Global Assessment to Treatment

9. Statistical Interpretation

10. Statistical Methods Explained

The registry identifies the primary outcome as continuous and reports least-squares means with standard errors for each treatment arm. A least-squares mean is a model-based mean; it need not be identical to a simple arithmetic average. The displayed group summaries are 3.981 for the indomethacin patch and 3.264 for placebo. Their posted standard errors are the same, but standard errors describe uncertainty in the estimated means, not the spread of individual participant scores.

What the mean difference describes

The mean difference compares the group mean on the outcome scale. The simple recalculation gives a difference of 0.717 for indomethacin relative to placebo. Since the registry defines higher positive SPID as greater pain reduction, a positive difference points toward a higher average SPID in the indomethacin arm. The recalculation is unadjusted: it uses the posted arm summaries rather than the covariate-adjusted model used in the sponsor’s reported analysis.

In general, an unadjusted comparison summarizes the observed groups without accounting for covariates in a regression model. An adjusted analysis estimates a contrast after accounting for model terms. Adjustment can change the estimate or its uncertainty. The registry reports ANCOVA for the primary comparison but does not identify the covariates, model diagnostics, or other implementation details. The sponsor’s adjusted estimate is therefore the appropriate result to cite as the reported trial analysis; the recalculation is a supplementary way to understand the posted group summaries.

What the confidence interval and p-value address

In general, a confidence interval communicates uncertainty around an estimated effect. A narrower interval indicates greater precision, while a wider interval leaves more possible effect sizes compatible with the data. For a mean difference, zero represents no difference in means. The posted sponsor interval and the recalculated interval both have positive limits, although their endpoints differ slightly because the analyses differ.

A p-value measures how incompatible the data are with a specified null model, assuming that model and the analysis assumptions hold. It is not the probability that the null hypothesis is true, and it does not measure the probability that the observed difference arose by chance in a literal sense. The sponsor reports an adjusted p-value; the recalculated p-value is unadjusted. The registry does not report whether the primary test was part of a prespecified hierarchical testing procedure.

Why uncertainty estimates matter

The arm-level summaries report standard errors, and the recalculation derives an approximate pooled standard deviation from those values. That derivation is approximate because the posted summaries are model-based estimates rather than raw participant-level observations. In general, standard deviation describes variation among observations, whereas standard error describes uncertainty in an estimated mean. They answer different questions and should not be used interchangeably.

The recalculated interval and p-value are simple, unadjusted estimates from posted summary statistics. They do not reproduce the sponsor’s ANCOVA model, and they cannot account for details unavailable in the registry record. Because the discrepancy indicator is false, the posted summary statistics and the sponsor’s reported result are not flagged as materially discrepant in this analysis. Even so, the distinction between adjusted and unadjusted methods remains important.

Interpreting secondary comparisons

The secondary outcomes include continuous measures and a count of participants using rescue medication. For continuous measures, mean differences compare average scores. For the rescue-medication outcome, the recalculation reports a risk difference, which compares the proportions with the event. In general, a confidence interval for a risk difference describes uncertainty in the difference between those proportions; an interval crossing zero is compatible with no difference under that analysis.

Secondary p-values are unadjusted in the posted recalculations. If many outcomes are tested, the chance of at least one apparently unusual result can increase. In general, multiplicity procedures address this issue by controlling error across a family of comparisons or by defining an order for testing. The registry record does not report a multiplicity procedure, so isolated secondary p-values should be interpreted cautiously.

The registry lists 11 secondary outcomes, but only a subset has numerical comparisons detailed in the analysis data. Absence of a numerical comparison for an outcome does not establish that it was not measured; its result or analysis details are not reported in the registry record. The same caution applies to missing-data methods, sensitivity analyses, and covariate specifications: these should not be reconstructed from the summaries.

11. Confidence Intervals and Precision

The primary mean-difference estimate is 0.717, and its recalculated confidence interval extends from a positive lower limit to a positive upper limit. The sponsor’s adjusted estimate is 0.72, with a 95% confidence interval that likewise remains above zero. The two analyses therefore agree on the direction of the primary difference and on the fact that their reported intervals exclude zero. Their estimates are close, but they are not identical because the sponsor’s result is adjusted and the recalculation is unadjusted.

Precision concerns the range of effect sizes that remain compatible with the data, not whether the result is clinically important. In general, a confidence interval is more informative than a point estimate alone because it conveys both direction and uncertainty. Here, the primary interval indicates a positive difference on the SPID scale under the analyses reported. The registry does not provide a threshold for judging whether a particular difference is clinically meaningful.

The arm summaries give standard errors, and the recalculated uncertainty uses an approximate pooled standard deviation derived from those summaries. The approximation means that the recalculated interval should be read as a summary-statistic calculation, not as a reproduction of the full trial model. The registry’s ANCOVA interval is the sponsor’s reported inferential result.

Precision also differs across outcomes. For example, the global-assessment comparison has a wide interval that includes zero, and the rescue-medication risk-difference interval includes zero. Those intervals allow a range of possible effects and do not establish a clear difference for those outcomes. Different outcome scales and event counts make the intervals unsuitable for direct comparison of clinical importance. The registry record does not report further precision analyses or subgroup-specific estimates.

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 planning figures are participants per arm for the continuous outcomes and binary outcome in this trial; they are not total event counts. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set as the stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

For the primary SPID outcome, planning for 100% of the observed effect gives 193 participants per arm for 80% power and 259 participants per arm for 90% power. Planning for 75% of the observed effect gives 343 participants per arm for 80% power and 459 participants per arm for 90% power. Planning for 50% of the observed effect gives 772 participants per arm for 80% power and 1,033 participants per arm for 90% power.

In general, power is the probability that a study will detect a specified effect under stated assumptions if that effect is present. The 80% and 90% columns show the planned number of participants per arm for those respective design targets, using the assumptions above. A smaller target effect requires more participants because it is harder to distinguish from random variation. These figures are planning illustrations based on the observed effect, not observed power, and they do not establish what sample size the trial investigators originally planned.

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 = 0.717; pooled standard deviation σ = 2.513.
2. n = 2 × (1.96 + 0.842)² × 2.513² / 0.717² = 192.9, rounded up to 193 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 <- 0.717                      # observed difference in means
sigma <- 2.51317889335399                     # 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(1957215)
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 = 193 (80% power), 259 (90% power)
 75% of observed effect: n per arm = 343 (80% power), 459 (90% power)
 50% of observed effect: n per arm = 772 (80% power), 1,033 (90% power)
power.t.test: 193.8 
Simulated power at n = 193 per arm: 0.797 (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 primary analysis is reported as ANCOVA, with an adjusted mean difference of 0.72 and a 95% confidence interval. Its reported p-value is close to the recalculated unadjusted p-value of 0.019. Both approaches give a positive difference, consistent with the higher posted SPID mean in the indomethacin arm.

The recalculation is not a replacement for the sponsor’s model. It is an unadjusted calculation from arm-level summaries and uses an approximate standard deviation inferred from the posted standard errors. ANCOVA can account for covariates, but the registry record does not identify which covariates were included or provide other model details. As a result, the adjusted and unadjusted results should be distinguished rather than treated as identical analyses.

The discrepancy indicator is false, so the posted summary statistics do not trigger a discrepancy flag. The sponsor’s own analysis takes precedence when describing the trial’s primary reported analysis. The recalculation is useful as a transparent check on the direction and approximate size of the contrast, while leaving the sponsor’s adjusted estimate as the trial’s reported result.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary endpoint and lists 11 secondary outcomes. It reports a sponsor ANCOVA analysis for the primary endpoint and provides unadjusted recalculations for the secondary outcomes with numerical summaries. A multiplicity adjustment, such as a prespecified testing sequence or a procedure controlling error across secondary tests, is not reported in the registry record.

In general, testing multiple outcomes creates more opportunities for chance findings than testing a single outcome. Unadjusted p-values answer questions about individual comparisons under their own assumptions; they do not account for the number of outcomes examined. The primary endpoint has a clearer role in the reported analysis, whereas secondary findings should be interpreted with additional caution when the testing strategy is unknown.

The primary analysis population is described as the Intent-to-Treat population, defined as participants who received study treatment and had at least one post-baseline efficacy measurement. The registry does not report how many randomized participants failed to meet this definition, how missing measurements were handled, or whether any sensitivity analyses assessed the effect of missing data. It also does not report whether all randomized participants were included in each secondary analysis.

The record does not report the trial’s original sample-size justification, interim analyses, model covariates, or detailed statistical analysis plan. These gaps limit assessment of whether the analyses followed a fully prespecified strategy. They do not establish that such procedures were absent from the trial conduct; the relevant information is not reported in the registry record.

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 0.5% reporting threshold.

Most frequent non-serious adverse event terms

The posted serious adverse event counts are zero in the indomethacin patch group and zero in the placebo patch group. Each group lists 135 participants at risk. This describes the serious adverse event figures recorded in the registry and does not establish that no adverse events of any kind occurred.

For other adverse events, the registry lists 10 participants in the indomethacin group and 5 in the placebo group, with 135 at risk in each arm. These are participant counts, not event rates or measures of severity. The record does not provide the specific non-serious adverse-event terms in the information, and deaths are not reported in the registry record.

In general, adverse-event comparisons need to be interpreted in light of how events were defined, collected, and followed. The registry record does not give enough detail to assess those procedures or to make a comprehensive safety comparison. These counts describe posted observations; they should not be treated as proof of safety or as a basis for medical advice.

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

The primary result describes a difference in average SPID scores between the randomized groups over the period from baseline on Day 1 to Day 3. The posted group means and both the sponsor’s adjusted analysis and the unadjusted recalculation point toward higher SPID in the indomethacin patch group. The sponsor reports an adjusted difference of 0.72; the recalculation gives an unadjusted difference of 0.717.

This finding is specific to the endpoint definition, study population, and assessment period in the registry. SPID is a time-weighted summary of measured pain-intensity changes, not a direct count of participants who achieved a particular level of relief. The record does not report a clinically meaningful difference threshold, so the statistical comparison alone cannot determine the practical importance of the average difference.

The primary result also does not establish that every participant had the same response, nor does it characterize the distribution of individual outcomes. The posted summaries are group-level estimates. The registry does not report subgroup results, detailed missing-data analyses, or all statistical-model specifications needed to assess those questions.

Secondary findings are not uniformly precise, and the registry does not report a multiplicity strategy. They therefore do not justify extending the primary finding to every pain measure or outcome. Likewise, the serious adverse event counts and other adverse-event counts are limited registry summaries, not a complete assessment of risks.

In general, a randomized comparison can estimate a treatment contrast under the study conditions, but interpretation depends on the design, measurement, analysis, and completeness of reporting. The record supports describing the posted statistical results and their uncertainty. It does not support medical advice, a claim about an individual’s likely outcome, or a conclusion beyond the outcomes and period measured.

18. Why This Trial Matters Statistically

This trial illustrates why endpoint definition matters. SPID is not a single pain score; it combines pain-intensity differences over time and weights them by the intervals between assessments. A group mean on this endpoint therefore represents an average time-weighted summary, and its interpretation depends on the stated direction of the scale: positive and higher values indicate greater pain reduction.

It also illustrates the distinction between an adjusted analysis and a summary-statistic recalculation. The sponsor’s ANCOVA estimate is the reported primary analysis, while the recalculation offers an unadjusted comparison derived from posted means and standard errors. Their close alignment in direction provides a useful consistency check, but it does not make the methods interchangeable or reveal the details of the sponsor’s model.

Precision and clinical importance are separate questions. The primary interval excludes zero, but the registry does not report a threshold for a clinically meaningful SPID difference. A statistically distinguishable average difference should therefore not be presented as a complete account of individual benefit or practical importance.

The trial also has several outcomes. Secondary measures can provide context, but unadjusted results across multiple comparisons carry less weight when the testing strategy is not reported. Finally, the sample-size illustrations demonstrate how planning requirements depend on the target effect and assumptions; they are not a substitute for the trial’s original design rationale, which is not reported in the registry record.

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 does not give the original sample-size justification, detailed randomization procedures, masking procedures, or the covariates used in the primary ANCOVA. It also does not report the complete statistical analysis plan, interim analyses, or a multiplicity strategy. These omissions limit assessment of how the reported analyses relate to prespecified design decisions.

The primary analysis population includes participants who received treatment and had at least one post-baseline efficacy measurement. The number excluded from this definition and the handling of missing outcome data are not reported in the registry record. Without those details, the potential influence of missing data cannot be evaluated from the posted summaries.

The recalculated primary comparison is unadjusted and uses an approximate standard deviation derived from group-level standard errors. It is not a reproduction of the sponsor’s ANCOVA. The sponsor’s adjusted result should remain the primary reported analysis, while the recalculation is interpreted as a supplementary summary-based estimate.

The registry lists multiple secondary measures, but not all have numerical results in the analysis data. The record does not report clinical-importance thresholds for the pain scores, detailed outcome distributions, or subgroup results. The adverse-event information is also limited: the reported counts do not provide specific terms for other adverse events, and deaths are not reported in the registry record.

These limitations concern what can be assessed from the registry record. They do not establish that unreported procedures or analyses were not conducted.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief — NCT01957215.
• Registry record last updated 2015-06-15; status last verified 2015-04.
• Results first posted 2015-06-15.
• 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

NCT01957215 is a completed Phase 4, randomized, double-masked, parallel-group trial comparing an indomethacin patch with a placebo patch for ankle-sprain pain. The registry lists enrollment of 270, with 135 participants in each primary outcome arm. Both patches were to be applied to the sprained ankle twice a day.

The primary endpoint was SPID from baseline on Day 1 to Day 3. Higher positive scores indicate greater pain reduction. The posted means were 3.981 for indomethacin and 3.264 for placebo. The sponsor reported an adjusted mean difference of 0.72; the unadjusted recalculation estimated a difference of 0.717.

The record lists 11 secondary outcomes, but does not report a multiplicity procedure, missing-data methods, or the original sample-size justification. The posted serious adverse event count was zero in each arm. These results describe the registry record and do not constitute medical advice.