Trial · NCT01303224
Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
NCT01303224, Phase 2, Completed, Menarini Group; results first posted 2013-03-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D). Trials, record NCT01303224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01303224
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
- NCT number
- NCT01303224
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 565 participants, actual
- Lead sponsor
- Menarini Group
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Interventions
- Ibodutant, Ibodutant, Ibodutant, Placebo
- First posted
- 2011-02-24
- Last updated
- 2015-10-07
- Other registries' IDs
- eudract:2010-018300-85
- Results first posted
- 2013-03-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Eight weeks | Weekly binary questions (yes/no) from Interactive Voice/Web Response (IV/WRS) diary records: "Did you have satisfactory relief of your overall IBS symptoms during the last week?" and "Did you have satisfactory relief of your abdominal pain or discomfort during the last week?" Responder: Report of satisfactory overall IBS symptom relief ="Yes" and of satisfactory abdominal pain/discomfort relief = "Yes" 6/8 weeks (75% rule) |
| Secondary | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Eight weeks | Weekly binary questions (yes/no) from IV/WRS diary records: "Did you have satisfactory relief of your overall IBS symptoms during the last week?" and "Did you have satisfactory relief of your abdominal pain or discomfort during the last week?" Responder: Report of satisfactory overall IBS symptom relief ="Yes" and of satisfactory abdominal pain/discomfort relief = "Yes" 4/8 weeks with at least 2 consecutive weeks of satisfactory relief during Week 5 to Week 8(50% rule) |
| Secondary | Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Eight weeks | Change in EQ-5D Quality of Life (visual analogue scale) score at the end of 8 weeks of treatment versus baseline (at randomisation). EQ-5D quality of life visual analogue scale ranges from "0"= worst imaginable health state to "100"=best imaginable health state. |
| Other | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Eight weeks | Weekly binary questions (yes/no) from IV/WRS diary records: "Did you have satisfactory relief of your overall IBS symptoms during the last week?" and "Did you have satisfactory relief of your abdominal pain or discomfort during the last week?" Responder: Report of satisfactory overall IBS symptom relief ="Yes" and of satisfactory abdominal pain/discomfort relief = "Yes" 6/8 weeks (75% rule) |
| Other | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Eight weeks | Weekly binary questions (yes/no) from IV/WRS diary records: "Did you have satisfactory relief of your overall IBS symptoms during the last week?" and "Did you have satisfactory relief of your abdominal pain or discomfort during the last week?" Responder: Report of satisfactory overall IBS symptom relief ="Yes" and of satisfactory abdominal pain/discomfort relief = "Yes" 6/8 weeks (75% rule) |
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 | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Eight weeks | Intention-to-Treat (559) | participants | NUMBER |
| SECONDARY | Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Eight weeks | Intention-to-Treat (559) | participants | NUMBER |
| SECONDARY | Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) | Eight weeks | Intention-to-treat; i.e. all ITT patients who provided EQ-5D data at Visit 2 (start of treatment) and Visit 4 (end of treatment). | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population | Eight weeks | Intention-to-Treat in the female population (333) | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population | Eight weeks | Intention-to-Treat in the male population (226) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Ibodutant 1 mg | Responders according to the 75% rule/Yes | 45 | participants | |
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Ibodutant 3 mg | Responders according to the 75% rule/Yes | 46 | participants | |
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Ibodutant 10 mg | Responders according to the 75% rule/Yes | 55 | participants | |
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Placebo | Responders according to the 75% rule/Yes | 39 | participants | |
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Ibodutant 1 mg | Responders according to the 75% rule/No | 95 | participants | |
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Ibodutant 3 mg | Responders according to the 75% rule/No | 92 | participants | |
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Ibodutant 10 mg | Responders according to the 75% rule/No | 84 | participants | |
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). | Placebo | Responders according to the 75% rule/No | 103 | participants | |
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Ibodutant 1 mg | Responders according to the 50% rule/Yes | 72 | participants | |
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population | Ibodutant 3 mg | Responders according to the 50% rule/Yes | 61 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibodutant 1 mg | 141 | |
| Overall Study | STARTED | Ibodutant 3 mg | 142 | |
| Overall Study | STARTED | Ibodutant 10 mg | 139 | |
| Overall Study | STARTED | Placebo | 143 | |
| Overall Study | Intention To Treat | Ibodutant 1 mg | 140 | |
| Overall Study | Intention To Treat | Ibodutant 3 mg | 138 | |
| Overall Study | Intention To Treat | Ibodutant 10 mg | 139 | |
| Overall Study | Intention To Treat | Placebo | 142 | |
| Overall Study | COMPLETED | Ibodutant 1 mg | 130 | |
| Overall Study | COMPLETED | Ibodutant 3 mg | 131 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events56
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 | Gastrointestinal disorders | Ibodutant 1 mg | 1 | 141 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Ibodutant 3 mg | 2 | 142 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Ibodutant 10 mg | 0 | 139 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 143 | 4 |
| other | Nausea | Gastrointestinal disorders | Ibodutant 1 mg | 1 | 141 | 1 |
| other | Nausea | Gastrointestinal disorders | Ibodutant 3 mg | 4 | 142 | 4 |
| other | Nausea | Gastrointestinal disorders | Ibodutant 10 mg | 5 | 139 | 5 |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 143 | 3 |
| other | Gastroenteritis | Infections and infestations | Ibodutant 1 mg | 0 | 141 | 0 |
| other | Gastroenteritis | Infections and infestations | Ibodutant 3 mg | 2 | 142 | 2 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibodutant 1 mg | ||
| Total, all-cause mortality | Ibodutant 3 mg | ||
| Total, all-cause mortality | Ibodutant 10 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ibodutant 1 mg | 20 | 141 |
| Total, other adverse events | Ibodutant 3 mg | 19 | 142 |
| Total, other adverse events | Ibodutant 10 mg | 29 | 139 |
| Total, other adverse events | Placebo | 20 | 143 |
| Total, serious adverse events | Ibodutant 1 mg | 0 | 141 |
| Total, serious adverse events | Ibodutant 3 mg | 1 | 142 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27196574 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01303224/results?page=2