Trial · NCT00761007

Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)

NCT00761007, Phase 2, Completed, Menarini Group; results first posted 2010-10-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ibodutant for Relief of Irritable Bowel Syndrome (IRIS). Trials, record NCT00761007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00761007

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)
NCT number: NCT00761007
Status: Completed
Phases: Phase 2
Enrollment: 554 participants, actual
Lead sponsor: Menarini Group
Conditions: Irritable Bowel Syndrome
Interventions: Ibodutant, Ibodutant, Ibodutant, Placebo
First posted: 2008-09-26
Last updated: 2012-03-21
Other registries' IDs: eudract:2008-000214-71
Results first posted: 2010-10-01

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response of Overall IBS Symptom Relief - 50% Rule	Four weeks	Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?" Responder: report of satisfactory overall IBS symptom relief = "Yes" 2/4 weeks (50% rule)
Secondary	Response of Overall IBS Symptom Relief - 75% Rule	Four weeks	Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?" Responder: report of satisfactory overall IBS symptom relief = "Yes" 3/4 weeks (75% rule)
Secondary	Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule	Four weeks	Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?" Responder: report of satisfactory overall IBS symptom relief = "Yes" 3/4 weeks (75% rule)

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	Response of Overall IBS Symptom Relief - 50% Rule	Four weeks	Intention-to-Treat (N=544)	Participants	NUMBER
SECONDARY	Response of Overall IBS Symptom Relief - 75% Rule	Four weeks	Intention-to-Treat (N=544)	Participants	NUMBER
POST_HOC	Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS-Diarrhea (IBS-D) and Pain at Baseline - 75% Rule	Four weeks	Intention-to-treat subgroup of patients with IBS-D and baseline pain score\>1 (in a 5-point scale ranging from 0=no pain to 4=very severe) (N=189)	Participants	NUMBER
SECONDARY	Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule	Four weeks	Intention-to-treat (ITT) subgroup of patients with IBS-D (N=234)	Participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Response of Overall IBS Symptom Relief - 50% Rule	Ibodutant 10 mg	79	Participants
Response of Overall IBS Symptom Relief - 50% Rule	Ibodutant 30 mg	61	Participants
Response of Overall IBS Symptom Relief - 50% Rule	Ibodutant 60 mg	61	Participants
Response of Overall IBS Symptom Relief - 50% Rule	Placebo	78	Participants
Response of Overall IBS Symptom Relief - 75% Rule	Ibodutant 10 mg	53	Participants
Response of Overall IBS Symptom Relief - 75% Rule	Ibodutant 30 mg	39	Participants
Response of Overall IBS Symptom Relief - 75% Rule	Ibodutant 60 mg	37	Participants
Response of Overall IBS Symptom Relief - 75% Rule	Placebo	48	Participants
Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS-Diarrhea (IBS-D) and Pain at Baseline - 75% Rule	Ibodutant 10 mg	31	Participants
Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS-Diarrhea (IBS-D) and Pain at Baseline - 75% Rule	Ibodutant 30 mg	15	Participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ibodutant 10 mg	142
Overall Study	STARTED	Ibodutant 30 mg	135
Overall Study	STARTED	Ibodutant 60 mg	139
Overall Study	STARTED	Placebo	138
Overall Study	Safety (>=1 Dose of Study Medication)	Ibodutant 10 mg	140
Overall Study	Safety (>=1 Dose of Study Medication)	Ibodutant 30 mg	135
Overall Study	Safety (>=1 Dose of Study Medication)	Ibodutant 60 mg	139
Overall Study	Safety (>=1 Dose of Study Medication)	Placebo	137
Overall Study	ITT (>= 1 Assessment Post-Randomisation)	Ibodutant 10 mg	140
Overall Study	ITT (>= 1 Assessment Post-Randomisation)	Ibodutant 30 mg	133

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events72

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 10 mg	4	140	5
other	Abdominal pain	Gastrointestinal disorders	Ibodutant 30 mg	5	135	5
other	Abdominal pain	Gastrointestinal disorders	Ibodutant 60 mg	5	139	5
other	Abdominal pain	Gastrointestinal disorders	Placebo	1	137	1
other	Abdominal pain upper	Gastrointestinal disorders	Ibodutant 10 mg	0	140	0
other	Abdominal pain upper	Gastrointestinal disorders	Ibodutant 30 mg	1	135	1
other	Abdominal pain upper	Gastrointestinal disorders	Ibodutant 60 mg	3	139	4
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	2	137	2
other	Back pain	Musculoskeletal and connective tissue disorders	Ibodutant 10 mg	3	140	3
other	Back pain	Musculoskeletal and connective tissue disorders	Ibodutant 30 mg	1	135	1

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ibodutant 10 mg
Total, all-cause mortality	Ibodutant 30 mg
Total, all-cause mortality	Ibodutant 60 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Ibodutant 10 mg	29	140
Total, other adverse events	Ibodutant 30 mg	29	135
Total, other adverse events	Ibodutant 60 mg	28	139
Total, other adverse events	Placebo	26	137
Total, serious adverse events	Ibodutant 10 mg	0	140
Total, serious adverse events	Ibodutant 30 mg	3	135

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00761007

GET https://conductscience.org/api/trials/v1/NCT00761007/events?page=2

API reference For AI assistants