Comparison · NCT03806127-934d8a94
Vibegron 75 mg vs Placebo: Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Vibegron 75 mg vs Placebo: Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12. Trial comparisons, record NCT03806127-934d8a94. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03806127-934d8a94
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.409 | 0.299 | 0.53 | wilson | |
| Risk in group 2 | 0.429 | 0.314 | 0.551 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0195 | -0.185 | 0.147 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.955 | 0.636 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 0.923 | 0.458 | 1.86 | log | |
| Number needed to treat, for one fewer participant with the outcome on Vibegron 75 mg than on Placebo | 51.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Vibegron 75 mg | Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M). | 27 | 66 | OG001 |
| Group 2 | Placebo | Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]). | 27 | 63 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
- Description
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of worst abdominal pain in the past 24 hours scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
- Time frame
- Baseline; Week 12
- Population
Full Analysis Set for IBS-D participants: all randomized participants with IBS-D who who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly API score (i.e., where evaluable was considered a minimum of 5 diary entries in a week)
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
- NCT number
- NCT03806127
- Phases
- PHASE2
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Vibegron, Placebo
- Lead sponsor
- Urovant Sciences GmbH
- Results first posted
- 2021-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03806127?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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