Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea caused by Irritable Bowel Syndrome in women.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter 2-Week Pilot Study to Evaluate the Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) Given Orally in Female Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: DNK333


Participation Criteria
=================
Eligibility Criteria
-----------------
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. Note: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DNK333<br>* 25 mg and 100 mg oral doses, each taken twice daily<br>|
| Experimental: 2<br> | Drug: DNK333<br>* 25 mg and 100 mg oral doses, each taken twice daily<br>|
| Placebo Comparator: 3<br> | Drug: DNK333<br>* 25 mg and 100 mg oral doses, each taken twice daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in average stool form score at 2 weeks |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in average score at week 1, week 2: Abdominal pain/discomfort, bloating; satisfaction with bowel habits; weekly stool frequency; percent of days with satisfactory control of bowel urgency; satisfactory relief of overall IBS symptoms |  | 2 weeks | 

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