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

Novartis

Status and phase

Completed

Phase 2

Conditions

Irritable Bowel Syndrome With Diarrhea (IBS-D)

Treatments

Drug: DNK333

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

CDNK333B2202

Details and patient eligibility

About

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

Enrollment

180 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.