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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

  Hide Study Locations
Locations
United States, Alabama
Anniston, Alabama, United States, 36207
Huntsville, Alabama, United States, 35801
Northport, Alabama, United States, 35476
United States, Arizona
Tucson, Arizona, United States, 85712
United States, Arkansas
North Little Rock, Arkansas, United States, 72117
United States, California
Orange, California, United States, 92869
Riverside, California, United States, 92506
San Diego, California, United States, 92108
Torrance, California, United States, 90505
United States, Connecticut
Bristol, Connecticut, United States, 06010
Hartford, Connecticut, United States, 06106
United States, Florida
Hollywood, Florida, United States, 33021
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Kansas
Arkansas City, Kansas, United States, 67005
United States, Kentucky
Lexington, Kentucky, United States, 40504
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Missouri
Mexico, Missouri, United States, 65265
Washington, Missouri, United States, 63090
United States, Nebraska
Lincoln, Nebraska, United States, 68503
United States, Ohio
Dayton, Ohio, United States, 45440
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Beaver Falls, Pennsylvania, United States, 15010
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Memphis, Tennessee, United States, 38119
Nashville, Tennessee, United States, 37205
United States, Texas
Austin, Texas, United States, 78758
Lake Jackson, Texas, United States, 77566
United States, Utah
Salt Lake City, Utah, United States, 84102
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
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014