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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00699166
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 17, 2008
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Brief Summary:
This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea caused by Irritable Bowel Syndrome in women.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: DNK333 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : April 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in average stool form score at 2 weeks [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00699166

  Hide Study 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
OverallOfficial: Novartis

Responsible Party: External Affairs, Novartis Identifier: NCT00699166     History of Changes
Other Study ID Numbers: CDNK333B2201
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by Novartis:
gastrointestinal functional disorder

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