Efficacy, Safety and Tolerability of DNK333 (25 mg Bid) in Women With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of DNK333 25mg b.i.d. Given Orally for 4 Weeks in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

Conditions
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Irritable Bowel Syndrome With Diarrhea (IBS-D)

Intervention / Treatment
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* Drug: DNK333
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Women of 18 - 65 years of age with IBS-D as defined by the Rome II criteria. The Rome II criteria is a system used for diagnosing functional gastrointestinal disorders such as irritable bowel syndrome. It involves completing of a questionnaire about gastrointestinal symptoms. Patients who are 50 years of age and older must have had a colonoscopy OR a flexible sigmoidoscopy plus a double-contrast barium enema within the past 5 years, which demonstrated no clinically significant findings. Clinically significant findings may include but are not limited to malignant tumors, multiple (≥3) or advanced adenomas, inflammatory bowel disease, diverticulitis, ischaemic colitis, lymphocytic colitis, or collagenous colitis. Patients must report ≥ 3 days with IBS-related abdominal pain/discomfort plus at least 3 days of 2 or more of the following events during the baseline period: ≥ 3 bowel movements/day Bowel urgency Loose or watery stool Exclusion Criteria: Patients who answer yes to either or both of the two weekly satisfaction questions during the baseline period. The questions are: (1) Over the past week did you have satisfactory relief of your IBS-related abdominal pain/discomfort? (2) Over the last week did you have satisfactory relief of your overall IBS-D symptoms? Patients with hard or lumpy stools for more than one day during the baseline period. Lactose intolerant patients relieved on a lactose free diet. Use of antidepressants (tricyclic, SSRI etc), opioid analgesic drugs or drugs specifically affecting bowel motility during the course of the trial. Women of child-bearing potential who do not use an acceptable methods of contraception. Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DNK333<br>* DNK333 25mg b.i.d. given orally for 4 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfactory relief of IBS-related abdominal pain/discomfort |  | 4 weeks | 
| Satisfactory relief of overall IBS-D symptoms |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and control of bowel urgency |  | 4 weeks | 
| Change in stool frequency |  | 4 weeks | 
| Severity of abdominal bloating |  | 4 weeks | 
| Severity of abdominal pain/discomfort |  | 4 weeks | 
| Safety |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, diarrhea, gastrointestinal functional disorder, IBS-D