Trial · NCT02107196
12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
NCT02107196, Phase 3, Completed, Menarini Group; results first posted 2016-09-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D). Trials, record NCT02107196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02107196
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
- NCT number
- NCT02107196
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 535 participants, actual
- Lead sponsor
- Menarini Group
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Interventions
- Ibodutant 10 mg, Placebo
- First posted
- 2014-04-08
- Last updated
- 2017-01-19
- Other registries' IDs
- eudract:2013-000894-56
- Results first posted
- 2016-09-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | 12 weeks | The patient will be considered a weekly responder if she meets both of the following criteria in the same week: * Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline; * Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stoll Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea. |
| Secondary | Weekly Response for Abdominal Pain Intensity Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | 12 weeks | The patient will be considered a weekly abdominal pain responder if she meets the following criterion: * Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline. |
| Secondary | Weekly Response for Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | 12 weeks | The patient will be considered a weekly stool consistency responder if she meets the following criterion: * Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stool Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea. |
| Secondary | Weekly Response for Relief of Overall IBS Signs and Symptoms Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | 12 weeks | The patient will be considered a weekly responder if she has an IBS degree-of-relief equal to "completely relieved/improved" or "considerably relieved/improved". |
| Secondary | Evaluation of Rebound Effects | 4 weeks | Comparison between average abdominal pain intensity (worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain) and average stool consistency score (the patients reported Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea) during the 4-week RW presented as change to baseline. The analysis only included the patients randomised to ibodutant in the 12-week treatment period and re-randomised to placebo for the 4-week RW period. Baseline was considered as the average abdominal pain intensity/stool consistency in the 2-week Run-in period. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | 12 weeks | The primary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA. | Percentage of Responders | NUMBER |
| SECONDARY | Weekly Response for Abdominal Pain Intensity Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | 12 weeks | The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA. | percentage of responders | NUMBER |
| SECONDARY | Weekly Response for Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | 12 weeks | The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA. | percentage of responders | NUMBER |
| SECONDARY | Weekly Response for Relief of Overall IBS Signs and Symptoms Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | 12 weeks | The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA. | percentage of responders | NUMBER |
| SECONDARY | Evaluation of Rebound Effects | 4 weeks | modified RW population: only patients randomised to ibodutant in the 12-week treatment period and re-randomized to placebo for the 4-week RW period (excluding patients from one site, where a potential serious breach of GCP was reported, and another site, where disqualification proceedings against the Investigator were confirmed by FDA). | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | Ibodutant 10 mg | 35.7 | Percentage of Responders | ||
| Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | Placebo | 34.7 | Percentage of Responders | ||
| Weekly Response for Abdominal Pain Intensity Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | Ibodutant 10 mg | 48.0 | percentage of responders | ||
| Weekly Response for Abdominal Pain Intensity Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | Placebo | 47.7 | percentage of responders | ||
| Weekly Response for Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | Ibodutant 10 mg | 44.8 | percentage of responders | ||
| Weekly Response for Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | Placebo | 43.1 | percentage of responders | ||
| Weekly Response for Relief of Overall IBS Signs and Symptoms Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | Ibodutant 10 mg | 21.3 | percentage of responders | ||
| Weekly Response for Relief of Overall IBS Signs and Symptoms Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). | Placebo | 19.0 | percentage of responders | ||
| Evaluation of Rebound Effects | Ibodutant 10 mg | Baseline-Abdominal Pain Score (NRS, 0-10 points) | 6.53 | Standard Deviation 1.60 | units on a scale |
| Evaluation of Rebound Effects | Ibodutant 10 mg | 4-week RW-Abdominal Pain Score (NRS, 0-10 points) | -3.11 | Standard Deviation 2.21 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 12-week Treatment Period | STARTED | Ibodutant 10 mg | 271 | |
| 12-week Treatment Period | STARTED | Placebo | 264 | |
| 12-week Treatment Period | Intention To Treat (ITT) | Ibodutant 10 mg | 271 | |
| 12-week Treatment Period | Intention To Treat (ITT) | Placebo | 264 | |
| 12-week Treatment Period | Modified ITT | Ibodutant 10 mg | 221 | |
| 12-week Treatment Period | Modified ITT | Placebo | 216 | |
| 12-week Treatment Period | COMPLETED | Ibodutant 10 mg | 227 | |
| 12-week Treatment Period | COMPLETED | Placebo | 225 | |
| 12-week Treatment Period | NOT COMPLETED | Ibodutant 10 mg | 44 | |
| 12-week Treatment Period | NOT COMPLETED | Placebo | 39 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events24
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 | Abdominal pain upper | Gastrointestinal disorders | Ibodutant 10 mg | 3 | 271 | 3 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 0 | 264 | 0 |
| other | Nausea | Gastrointestinal disorders | Ibodutant 10 mg | 3 | 271 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 264 | 1 |
| other | Gastroenteritis | Infections and infestations | Ibodutant 10 mg | 1 | 271 | 1 |
| other | Gastroenteritis | Infections and infestations | Placebo | 3 | 264 | 3 |
| other | Nasopharyngitis | Infections and infestations | Ibodutant 10 mg | 7 | 271 | 7 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 6 | 264 | 6 |
| other | Urinary tract infections | Infections and infestations | Ibodutant 10 mg | 8 | 271 | 8 |
| other | Urinary tract infections | Infections and infestations | Placebo | 7 | 264 | 8 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibodutant 10 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ibodutant 10 mg | 35 | 271 |
| Total, other adverse events | Placebo | 33 | 264 |
| Total, serious adverse events | Ibodutant 10 mg | 0 | 271 |
| Total, serious adverse events | Placebo | 2 | 264 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ibodutant 10 mg vs Placebo: serious adverse events |
Source 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/NCT02107196
GET https://conductscience.org/api/trials/v1/NCT02107196/events?page=2