Status:
COMPLETED
Efficacy, Safety and Tolerability of DNK333 (25 mg Bid) in Women With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Lead Sponsor:
Novartis
Conditions:
Irritable Bowel Syndrome With Diarrhea (IBS-D)
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.
Eligibility Criteria
Inclusion
- 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.
- 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 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00394173
Start Date
September 1 2006
End Date
October 1 2007
Last Update
February 27 2017
Active Locations (43)
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1
Investigative Site
Tucson, Arizona, United States, 85712
2
Investigative Site
North Little Rock, Arkansas, United States, 72114
3
Investigative Site
Los Angeles, California, United States, 90045-3119
4
Investigative Site
Orange, California, United States, 92869