Trial · NCT02959983
Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use
NCT02959983, Phase 4, Completed, Allergan; results first posted 2019-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use. Trials, record NCT02959983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02959983
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use
- NCT number
- NCT02959983
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 346 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Interventions
- Eluxadoline, Placebo
- First posted
- 2016-11-09
- Last updated
- 2019-02-15
- Results first posted
- 2019-02-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores | Baseline, Weeks 1 to 12 | Percentage of primary composite responders is defined as the percentage of participants who meet both of the following daily composite criteria for at least 50% of the days with diary entry: 1)Worst Abdominal Pain (WAP) score improved by ≥40% compared to Baseline. The participant records their WAP score in the past 24 hours each day in a daily patient diary where: 0=no pain to 10=worst imaginable pain. 2) Bristol Stool Score (BSS) \<5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool). |
| Secondary | Percentage of Stool Consistency Responders | Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12) | Percentage of stool consistency responders is defined as the percentage of participants who meet the daily stool consistency response criteria: BSS \<5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline for ≥50% of days with daily patient diary entries over a certain time period. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool). A participant must have had a minimum of 20 days of diary entries over any 4-week interval. |
| Secondary | Percentage of Pain Responders | Baseline, Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12) | Percentage of pain responders is defined as the percentage of participants who meet the daily pain response criteria: WAP score improved by ≥40% compared to Baseline for ≥50% of days with diary entries over a certain time period. The participant records their WAP score in the past 24 hours each day in a daily diary where: 0=no pain to 10=worst imaginable pain. A participant must have had a minimum of 20 days of diary entries over any 4-week interval. |
| Secondary | Percentage of Monthly Composite Responders | Weeks 1 to 4, 5 to 8, and 9 to 12 | Percentage of monthly composite responders is defined as the percentage of participants who meet the daily composite response criteria for at least 50% of days with diary entry for a minimum of 20 days during each 4-week interval (weeks 1 to 4, 5 to 8, and 9 to 12). Composite response includes both of the following criteria: 1) WAP score improved by ≥40% compared to Baseline. The participant records their WAP score in the past 24 hours each day in a daily patient diary where: 0=no pain to 10=worst imaginable pain. 2) BSS \<5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores | Baseline, Weeks 1 to 12 | The Intent-to-Treat population includes all randomized patients. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Stool Consistency Responders | Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12) | The Intent-to-Treat population includes all randomized patients. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Pain Responders | Baseline, Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12) | The Intent-to-Treat population includes all randomized patients. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Monthly Composite Responders | Weeks 1 to 4, 5 to 8, and 9 to 12 | The Intent-to-Treat population includes all randomized patients. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores | Eluxadoline | 22.7 | percentage of participants | ||
| Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores | Placebo | 10.3 | percentage of participants | ||
| Percentage of Stool Consistency Responders | Eluxadoline | Overall Weeks 1 to 12 | 27.9 | Percentage of Participants | |
| Percentage of Stool Consistency Responders | Placebo | Overall Weeks 1 to 12 | 16.7 | Percentage of Participants | |
| Percentage of Stool Consistency Responders | Eluxadoline | Weeks 1 to 4 | 24.4 | Percentage of Participants | |
| Percentage of Stool Consistency Responders | Placebo | Weeks 1 to 4 | 12.6 | Percentage of Participants | |
| Percentage of Stool Consistency Responders | Eluxadoline | Weeks 5 to 8 | 30.8 | Percentage of Participants | |
| Percentage of Stool Consistency Responders | Placebo | Weeks 5 to 8 | 20.1 | Percentage of Participants | |
| Percentage of Stool Consistency Responders | Eluxadoline | Weeks 9 to 12 | 29.7 | Percentage of Participants | |
| Percentage of Stool Consistency Responders | Placebo | Weeks 9 to 12 | 25.3 | Percentage of Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eluxadoline | 172 | |
| Overall Study | STARTED | Placebo | 174 | |
| Overall Study | COMPLETED | Eluxadoline | 146 | |
| Overall Study | COMPLETED | Placebo | 149 | |
| Overall Study | NOT COMPLETED | Eluxadoline | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 25 |
Source ClinicalTrials.gov
Adverse events20
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 | Nausea | Gastrointestinal disorders | Eluxadoline | 10 | 171 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 173 | |
| serious | Pancreatic mass | Gastrointestinal disorders | Eluxadoline | 1 | 171 | |
| serious | Pancreatic mass | Gastrointestinal disorders | Placebo | 0 | 173 | |
| serious | Cellulitis | Infections and infestations | Eluxadoline | 0 | 171 | |
| serious | Cellulitis | Infections and infestations | Placebo | 1 | 173 | |
| serious | Pneumonia | Infections and infestations | Eluxadoline | 0 | 171 | |
| serious | Pneumonia | Infections and infestations | Placebo | 1 | 173 | |
| serious | Cardiac failure congestive | Cardiac disorders | Eluxadoline | 0 | 171 | |
| serious | Cardiac failure congestive | Cardiac disorders | Placebo | 1 | 173 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eluxadoline | 0 | 171 |
| Total, all-cause mortality | Placebo | 0 | 173 |
| Total, other adverse events | Eluxadoline | 10 | 171 |
| Total, other adverse events | Placebo | 5 | 173 |
| Total, serious adverse events | Eluxadoline | 1 | 171 |
| Total, serious adverse events | Placebo | 3 | 173 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Eluxadoline vs Placebo: deaths from any cause | Trial comparisons |
| Eluxadoline vs Placebo: serious adverse events | Trial comparisons |
Tests0
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/NCT02959983
GET https://conductscience.org/api/trials/v1/NCT02959983/results?page=2