Comparison · NCT02686138-d7fd5d6e
50mg BID vs Placebo: Percentage of Subjects With Overall Response for 9 Out of 12 Weeks
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 50mg BID vs Placebo: Percentage of Subjects With Overall Response for 9 Out of 12 Weeks. Trial comparisons, record NCT02686138-d7fd5d6e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02686138-d7fd5d6e
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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 | 0.184 | 0.144 | 0.233 | wilson | |
| Risk in group 2 | 0.0533 | 0.0331 | 0.0849 | wilson | |
| Risk difference, group 1 minus group 2 | 0.131 | 0.0799 | 0.183 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.46 | 2.03 | 5.9 | log | |
| Odds ratio, group 1 over group 2 | 4.01 | 2.24 | 7.19 | log | |
| Number needed to treat, for one more participant with the outcome on 50mg BID than on Placebo | 7.64 | 5.45 | 12.5 | 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 | 54 | 293 | OG000 |
| Group 2 | Placebo | Placebo~Placebo | 16 | 300 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Subjects With Overall Response for 9 Out of 12 Weeks
- Description
An overall responder is defined as a weekly responder for the first 9/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. 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? The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
- Time frame
- First 12 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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