Irritable Bowel Syndrome With Diarrhea (IBS-D)
Conditions
Keywords
IBS, diarrhea, gastrointestinal functional disorder, IBS-D
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.
Interventions
DRUGDNK333
DNK333 25mg b.i.d. given orally for 4 weeks
DRUGPlacebo
Matching placebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Satisfactory relief of IBS-related abdominal pain/discomfort | 4 weeks |
| Satisfactory relief of overall IBS-D symptoms | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Severity of abdominal bloating | 4 weeks |
| Occurrence and control of bowel urgency | 4 weeks |
| Safety | 4 weeks |
| Severity of abdominal pain/discomfort | 4 weeks |
| Change in stool frequency | 4 weeks |
Countries
Canada, United States
Outcome results
None listed