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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: October 30, 2006
Last updated: October 1, 2008
Last verified: October 2008

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

Condition Intervention Phase
Irritable Bowel Syndrome With Diarrhea (IBS-D)
Drug: DNK333
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of DNK333 25mg b.i.d. Given Orally for 4 Weeks in Female Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Satisfactory relief of IBS-related abdominal pain/discomfort [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Satisfactory relief of overall IBS-D symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence and control of bowel urgency [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in stool frequency [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Severity of abdominal bloating [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Severity of abdominal pain/discomfort [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: September 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DNK333
DNK333 25mg b.i.d. given orally for 4 weeks
Placebo Comparator: 2 Drug: Placebo
Matching placebo


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394173

  Show 43 Study Locations
Sponsors and Collaborators
Study Chair: Novartis Pharmaceuticals Corp. NPC
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00394173     History of Changes
Other Study ID Numbers: CDNK333B2202
Study First Received: October 30, 2006
Last Updated: October 1, 2008
Health Authority: Canada: Canadian Therapeutic Products Directorate (TPD)
United States: Food and Drug Administration

Keywords provided by Novartis:
gastrointestinal functional disorder

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014