Comparison · NCT02686138-3df9fb82
50mg BID vs Placebo: Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks
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. 50mg BID vs Placebo: Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks. Trial comparisons, record NCT02686138-3df9fb82. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02686138-3df9fb82
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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 | 0.413 | 0.358 | 0.47 | wilson | |
| Risk in group 2 | 0.31 | 0.26 | 0.364 | wilson | |
| Risk difference, group 1 minus group 2 | 0.103 | 0.0256 | 0.179 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 1.07 | 1.66 | log | |
| Odds ratio, group 1 over group 2 | 1.57 | 1.12 | 2.19 | log | |
| Number needed to treat, for one more participant with the outcome on 50mg BID than on Placebo | 9.71 | 5.6 | 39 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 50mg BID | Tenapanor, 50mg BID (100mg total)~Tenapanor | 121 | 293 | OG000 |
| Group 2 | Placebo | Placebo~Placebo | 93 | 300 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks
- Description
An overall CSBM responder is defined as a weekly responder for the first 13/26 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels?
- Time frame
- 26 weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C
- NCT number
- NCT02686138
- Phases
- PHASE3
- Conditions
- Constipation Predominant Irritable Bowel Syndrome
- Interventions
- Tenapanor, Placebo
- Lead sponsor
- Ardelyx
- Results first posted
- 2020-04-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02686138?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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