Trial · NCT02686138
A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C
NCT02686138, Phase 3, Completed, Ardelyx; results first posted 2020-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C. Trials, record NCT02686138. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02686138
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C
- NCT number
- NCT02686138
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 593 participants, actual
- Lead sponsor
- Ardelyx
- Conditions
- Constipation Predominant Irritable Bowel Syndrome
- Interventions
- Tenapanor, Placebo
- First posted
- 2016-02-19
- Last updated
- 2020-04-22
- Results first posted
- 2020-04-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Overall Response for 6 Out of 12 Weeks | First 12 weeks | An overall responder is defined as a weekly responder for the first 6/12 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. 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. |
| Secondary | Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks | First 12 weeks | An overall CSBM responder is defined as a weekly responder for the first 6/12 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?" |
| Secondary | Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks | First 12 weeks | An overall abdominal pain responder is defined as a weekly responder for the first 6/12 weeks. 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. |
| Secondary | Percentage of Subjects With Overall Response for 13 Out of 26 Weeks | 26 weeks | An overall responder is defined as a weekly responder for the first 13/26 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. 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. |
| Secondary | Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks | 26 weeks | 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?" |
| Secondary | Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks | 26 weeks | An overall abdominal pain responder is defined as a weekly responder for the first 13/26 weeks. 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. |
| Secondary | Percentage of Subjects With Overall Response for 9 Out of 12 Weeks | First 12 weeks | 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. |
| Secondary | Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks | First 12 weeks | An overall CSBM responder is defined as a weekly responder for the first 9/12 weeks. 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?" |
| Secondary | Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks | First 12 weeks | An overall abdominal pain responder is defined as a weekly responder for the first 9/12 weeks. 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Overall Response for 6 Out of 12 Weeks | First 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks | First 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks | First 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Overall Response for 13 Out of 26 Weeks | 26 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks | 26 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks | 26 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Overall Response for 9 Out of 12 Weeks | First 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks | First 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks | First 12 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Overall Response for 6 Out of 12 Weeks | 50mg BID | 107 | Participants | ||
| Percentage of Subjects With Overall Response for 6 Out of 12 Weeks | Placebo | 71 | Participants | ||
| Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks | 50mg BID | 139 | Participants | ||
| Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks | Placebo | 100 | Participants | ||
| Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks | 50mg BID | 146 | Participants | ||
| Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks | Placebo | 115 | Participants | ||
| Percentage of Subjects With Overall Response for 13 Out of 26 Weeks | 50mg BID | 104 | Participants | ||
| Percentage of Subjects With Overall Response for 13 Out of 26 Weeks | Placebo | 73 | Participants | ||
| Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks | 50mg BID | 121 | Participants | ||
| Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks | Placebo | 93 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 50mg BID | 293 | |
| Overall Study | STARTED | Placebo | 300 | |
| Overall Study | COMPLETED | 50mg BID | 219 | |
| Overall Study | COMPLETED | Placebo | 235 | |
| Overall Study | NOT COMPLETED | 50mg BID | 74 | |
| Overall Study | NOT COMPLETED | Placebo | 65 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | 50mg BID | 47 | 293 | 47 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 11 | 300 | 11 |
| serious | Abdominal Pain | Gastrointestinal disorders | 50mg BID | 1 | 293 | 1 |
| serious | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 300 | 0 |
| serious | COPD | Respiratory, thoracic and mediastinal disorders | 50mg BID | 1 | 293 | 1 |
| serious | COPD | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 300 | 1 |
| serious | Diarrhea | Gastrointestinal disorders | 50mg BID | 1 | 293 | 1 |
| serious | Diarrhea | Gastrointestinal disorders | Placebo | 0 | 300 | 0 |
| serious | Nausea | Gastrointestinal disorders | 50mg BID | 1 | 293 | 1 |
| serious | Nausea | Gastrointestinal disorders | Placebo | 1 | 300 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 50mg BID | 0 | 293 |
| Total, all-cause mortality | Placebo | 0 | 300 |
| Total, other adverse events | 50mg BID | 47 | 293 |
| Total, other adverse events | Placebo | 11 | 300 |
| Total, serious adverse events | 50mg BID | 4 | 293 |
| Total, serious adverse events | Placebo | 8 | 300 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 50mg BID vs Placebo: Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks | Trial comparisons |
| 50mg BID vs Placebo: Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks | Trial comparisons |
| 50mg BID vs Placebo: Percentage of Subjects With Overall Response for 13 Out of 26 Weeks | Trial comparisons |
| 50mg BID vs Placebo: Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks | Trial comparisons |
| 50mg BID vs Placebo: Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks | Trial comparisons |
| 50mg BID vs Placebo: Percentage of Subjects With Overall Response for 6 Out of 12 Weeks | Trial comparisons |
| 50mg BID vs Placebo: Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks | Trial comparisons |
| 50mg BID vs Placebo: Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks | Trial comparisons |
| 50mg BID vs Placebo: Percentage of Subjects With Overall Response for 9 Out of 12 Weeks | Trial comparisons |
| 50mg BID vs Placebo: deaths from any cause | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02686138
GET https://conductscience.org/api/trials/v1/NCT02686138/events?page=2