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.
Information provided by:
ClinicalTrials.gov Identifier:
First received: June 12, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

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

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: DNK333
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in average stool form score at 2 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 135
Study Start Date: April 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DNK333
25 mg and 100 mg oral doses, each taken twice daily
Experimental: 2 Drug: DNK333
25 mg and 100 mg oral doses, each taken twice daily
Placebo Comparator: 3 Drug: DNK333
25 mg and 100 mg oral doses, each taken twice daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699166

  Show 29 Study Locations
Sponsors and Collaborators
Investigator: Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00699166     History of Changes
Other Study ID Numbers: CDNK333B2201
Study First Received: June 12, 2008
Last Updated: June 12, 2008
Health Authority: 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