Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D) (IRIS-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Menarini Group
ClinicalTrials.gov Identifier:
NCT01303224
First received: February 23, 2011
Last updated: March 21, 2013
Last verified: January 2013
  Purpose

Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.


Condition Intervention Phase
Irritable Bowel Syndrome With Diarrhea
Drug: Ibodutant
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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).

Resource links provided by NLM:


Further study details as provided by Menarini Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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)



Enrollment: 565
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibodutant low dose
Oral tablet, to be given once daily in fasting conditions.
Drug: Ibodutant
Oral tablet, low dose, once daily, for 8 weeks
Other Name: Code: MEN 15596
Experimental: Ibodutant intermediate dose
Oral tablet, to be given once daily in fasting conditions.
Drug: Ibodutant
Oral tablet, intermediate dose, once daily, for 8 weeks
Other Name: Code: MEN 15596
Experimental: Ibodutant high dose
Oral tablet, to be given once daily in fasting conditions.
Drug: Ibodutant
Oral tablet, high dose, once daily, for 8 weeks
Other Name: Code: MEN 15569
Placebo Comparator: Placebo
Oral tablet, to be given once daily in fasting conditions.
Drug: Placebo
Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks
Other Name: Sugar pill

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:
  • 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:

    1. improvement with defecation;
    2. onset associated with a change in the frequency of stool;
    3. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303224

  Show 71 Study Locations
Sponsors and Collaborators
Menarini Group
Investigators
Study Chair: Jan Tack, Professor Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium
  More Information

No publications provided

Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT01303224     History of Changes
Other Study ID Numbers: NAK-04, 2010-018300-85
Study First Received: February 23, 2011
Results First Received: January 10, 2013
Last Updated: March 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Poland: Ministry of Health
Spain: Ministry of Health
Sweden: Medical Products Agency

Keywords provided by Menarini Group:
Irritable Bowel Syndrome
Colon, irritable
Bowel disease

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 15, 2014