Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea
 caused by Irritable Bowel Syndrome in women.
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:

 1. ≥ 3 bowel movements/day

 2. Bowel urgency

 3. 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