Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (CDNK333B2201)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00699166
First received: June 12, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

June 12, 2008
June 12, 2008
April 2004
September 2005   (final data collection date for primary outcome measure)
Change from baseline in average stool form score at 2 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Change from baseline in average score at week 1, week 2: Abdominal pain/discomfort, bloating; satisfaction with bowel habits; weekly stool frequency; percent of days with satisfactory control of bowel urgency; satisfactory relief of overall IBS symptoms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
A Randomized, Double-Blind, Placebo-Controlled, Multicenter 2-Week Pilot Study to Evaluate the Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) Given Orally in Female Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea caused by Irritable Bowel Syndrome in women.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome
Drug: DNK333
25 mg and 100 mg oral doses, each taken twice daily
  • Experimental: 1
    Intervention: Drug: DNK333
  • Experimental: 2
    Intervention: Drug: DNK333
  • Placebo Comparator: 3
    Intervention: Drug: DNK333
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
September 2005
September 2005   (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.

Note: 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:

  1. ≥ 3 bowel movements/day
  2. Bowel urgency
  3. 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00699166
CDNK333B2201
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Investigator: Novartis
Novartis
June 2008

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