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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
History of Changes

October 30, 2006
October 1, 2008
September 2006
October 2007   (final data collection date for primary outcome measure)
  • 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 ]
  • IBS-related abdominal pain/discomfort
  • overall IBS-D symptoms
  • Weekly response to satisfactory relief assessments:
Complete list of historical versions of study NCT00394173 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Occurrence and control of bowel urgency
  • Change in stool frequency
  • Severity of abdominal bloating
  • Severity of abdominal pain/discomfort
  • Safety
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of DNK333 (25 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
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)

The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Irritable Bowel Syndrome With Diarrhea (IBS-D)
  • Drug: DNK333
    DNK333 25mg b.i.d. given orally for 4 weeks
  • Drug: Placebo
    Matching placebo
  • Experimental: 1
    Intervention: Drug: DNK333
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
October 2007
October 2007   (final data collection date for primary outcome measure)

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.
Female
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00394173
CDNK333B2202
Not Provided
Not Provided
Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Corp. NPC
Novartis
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP