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

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Diarrhea (IBS-D)

In brief

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

Key facts

Study ID

NCT00394173

Run by

Novartis

People needed

180

Starts

2006-09-01

Expected to finish

2007-10-01

Last updated by the study team

2017-02-27

Who can join

Age: 18 and older, up to 65. 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.
• 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.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Investigative Site — Tucson, Arizona, United States
• Investigative Site — North Little Rock, Arkansas, United States
• Investigative Site — Los Angeles, California, United States
• Investigative Site — Orange, California, United States
• Investigative Site — Riverside, California, United States
• Investigative Site — Sacramento, California, United States
• Investigative Site — San Diego, California, United States
• Investigative Site — Colorado Springs, Colorado, United States
• Investigative Site — Bristol, Connecticut, United States
• Investigative Site — Hartford, Connecticut, United States
• Investigative Site — Boca Raton, Florida, United States
• Investigative Site — Gainesville, Florida, United States
• Investigative Site — Hollywood, Florida, United States
• Investigative Site — Jacksonville, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — New Smyrna Beach, Florida, United States
• Investigative Site — Tampa, Florida, United States
• Investigative Site — Arlington Heights, Illinois, United States
• Investigative Site — Rockford, Illinois, United States
• Investigative Site — Boston, Massachusetts, United States
• Investigative Site — Wellesley Hills, Massachusetts, United States
• Investigative Site — Mexico, Missouri, United States
• Investigative Site — Buffalo, New York, United States
• Investigative Site — Great Neck, New York, United States
• Investigative Site — Elkin, North Carolina, United States

Full record on ClinicalTrials.gov

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