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
  Purpose

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

  Eligibility

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

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
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: NCT00699166

  Show 29 Study Locations
Sponsors and Collaborators
Novartis
Investigators
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:
IBS
Diarrhea
gastrointestinal functional disorder
IBS-D

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

ClinicalTrials.gov processed this record on October 16, 2014