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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01303224 |
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Date of registration:
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23/02/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
IRIS-2 |
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Scientific title:
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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). |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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565 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01303224 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Bulgaria
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Czech Republic
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Denmark
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Germany
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Italy
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Poland
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Spain
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Sweden
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Contacts
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Name:
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Jan Tack, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Irritable Bowel Syndrome With Diarrhea
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Intervention(s)
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Drug: Ibodutant
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Drug: Placebo
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)
[Time Frame: Eight weeks]
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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]
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Secondary ID(s)
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2010-018300-85
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NAK-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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