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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00394173
First received: October 30, 2006
Last updated: October 1, 2008
Last verified: October 2008
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 43 Study Locations
Sponsors and Collaborators
Novartis
Investigators
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:
IBS
diarrhea
gastrointestinal functional disorder
IBS-D

Additional relevant MeSH terms:
Diarrhea
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 August 18, 2014