Status:
COMPLETED
Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Lead Sponsor:
Novartis
Conditions:
Irritable Bowel Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea caused by Irritable Bowel Syndrome in women.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00699166
Start Date
April 1 2004
End Date
September 1 2005
Last Update
June 17 2008
Active Locations (29)
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1
Anniston, Alabama, United States, 36207
2
Huntsville, Alabama, United States, 35801
3
Northport, Alabama, United States, 35476
4
Tucson, Arizona, United States, 85712