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

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: DNK333

• Registration Number: NCT00699166
• Lead Sponsor: Novartis

Brief Summary

This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea caused by Irritable Bowel Syndrome in women.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2008-06
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-12
• Last Update Submitted: 2008-06-12
• Study First Posted: 2008-06-17
• Last Update Posted: 2008-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	DNK333	-
2	DNK333	-
3	DNK333	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in average stool form score at 2 weeks	2 weeks

Secondary Outcome Measures

Name	Time	Method
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