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

Completed · Phase 2

Conditions studied: Irritable Bowel Syndrome

In brief

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

Key facts

Study ID

NCT00699166

Run by

Novartis

People needed

135

Starts

2004-04-01

Expected to finish

2005-09-01

Last updated by the study team

2008-06-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Anniston, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Northport, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — North Little Rock, Arkansas, United States
• Study site — Orange, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Bristol, Connecticut, United States
• Study site — Hartford, Connecticut, United States
• Study site — Hollywood, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Arkansas City, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Mexico, Missouri, United States
• Study site — Washington, Missouri, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Dayton, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Beaver Falls, Pennsylvania, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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