Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D) (IRIS-2)
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| ClinicalTrials.gov Identifier: NCT01303224 |
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Recruitment Status :
Completed
First Posted : February 24, 2011
Results First Posted : March 25, 2013
Last Update Posted : October 7, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Irritable Bowel Syndrome With Diarrhea | Drug: Ibodutant Drug: Placebo | Phase 2 |
The study evaluates the efficacy and safety of three doses of ibodutant, given once daily for 8 weeks versus placebo in IBS-D patients. Efficacy is evaluated in terms of overall symptom relief and abdominal pain/discomfort relief after 8 weeks of treatment. The clinical phase of the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind treatment period and a 2-week treatment withdrawal period, resulting in a 10-week overall duration of the study for each patient.
Patients report their IBS-related symptoms daily in an electronic diary (web-and telephone based)during all periods of the study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 565 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Double-blind, Randomised, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Effect of Oral Ibodutant in Irritable Bowel Syndrome With Diarrhoea (IBS-D). |
| Study Start Date : | October 2010 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | July 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ibodutant low dose
Oral tablet, to be given once daily in fasting conditions.
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Drug: Ibodutant
Oral tablet, low dose, once daily, for 8 weeks
Other Name: Code: MEN 15596 |
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Experimental: Ibodutant intermediate dose
Oral tablet, to be given once daily in fasting conditions.
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Drug: Ibodutant
Oral tablet, intermediate dose, once daily, for 8 weeks
Other Name: Code: MEN 15596 |
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Experimental: Ibodutant high dose
Oral tablet, to be given once daily in fasting conditions.
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Drug: Ibodutant
Oral tablet, high dose, once daily, for 8 weeks
Other Name: Code: MEN 15569 |
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Placebo Comparator: Placebo
Oral tablet, to be given once daily in fasting conditions.
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Drug: Placebo
Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks
Other Name: Sugar pill |
- 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). [ Time Frame: 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)
- 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 [ Time Frame: 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)
- Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) [ Time Frame: 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.
- Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population [ Time Frame: 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)
- Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population [ Time Frame: 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)
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At start of the run-in period:
- Male or female patients aged 18 - 70 years with a clinical diagnosis of IBS-D according to the Rome III criteria:
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Recurrent abdominal pain/discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics:
- improvement with defecation;
- onset associated with a change in the frequency of stool;
- onset associated with a change in form (appearance) of stool.
- Symptom-onset at least 6 months prior to diagnosis.
- Loose/watery stools at least 25% of the time in the last 3 months AND hard/lumpy stools less than 25% of the time in the last 3 months.
- More than 3 bowel movements per day at least 25% of the time in the last 3 months.
- For patients older than 50 years OR patients with positive family history of colorectal cancer: Normal results from colonoscopy or flexible sigmoidoscopy.
- Mentally competent, able to give written informed consent.
- For women of childbearing potential: Use of a highly effective contraceptive method throughout the entire study period and up to 30 days post-treatment.
- Normal physical examination or without clinically relevant abnormalities.
At randomisation:
-Confirmation of IBS-D severity in terms of bowel movement frequency and abdominal pain intensity along the 2-week run-in period.
Exclusion criteria:
- Organic abnormalities of the gastrointestinal tract, including history of colonic or major abdominal surgery.
- History of gluten enteropathy.
- Lactose intolerance as assessed by response to diet.
- History of positive tests for ova or parasites, or occult blood in the stool.
- Previous diagnosis of diabetes mellitus (either type 1 or 2).
- Unstable medical condition.
- Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease.
- Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months.
- Use of concurrent medication with drugs known to interfere with gastro-intestinal motility or sensitivity.
- Pregnancy or breastfeeding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303224
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| Study Chair: | Jan Tack, Professor | Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium |
| Responsible Party: | Menarini Group |
| ClinicalTrials.gov Identifier: | NCT01303224 |
| Other Study ID Numbers: |
NAK-04 2010-018300-85 ( EudraCT Number ) |
| First Posted: | February 24, 2011 Key Record Dates |
| Results First Posted: | March 25, 2013 |
| Last Update Posted: | October 7, 2015 |
| Last Verified: | September 2015 |
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Irritable Bowel Syndrome Colon, irritable Bowel disease |
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Irritable Bowel Syndrome Syndrome Diarrhea Disease Pathologic Processes Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Signs and Symptoms, Digestive |