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

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: NCT00394173
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : February 27, 2017
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Brief Summary:
The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Diarrhea (IBS-D) Drug: DNK333 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of DNK333 25mg b.i.d. Given Orally for 4 Weeks in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Study Start Date : September 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: 1 Drug: DNK333
DNK333 25mg b.i.d. given orally for 4 weeks

Placebo Comparator: 2 Drug: Placebo
Matching placebo

Primary Outcome Measures :
  1. Satisfactory relief of IBS-related abdominal pain/discomfort [ Time Frame: 4 weeks ]
  2. Satisfactory relief of overall IBS-D symptoms [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Occurrence and control of bowel urgency [ Time Frame: 4 weeks ]
  2. Change in stool frequency [ Time Frame: 4 weeks ]
  3. Severity of abdominal bloating [ Time Frame: 4 weeks ]
  4. Severity of abdominal pain/discomfort [ Time Frame: 4 weeks ]
  5. Safety [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female

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.
  • 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:
  • ≥ 3 bowel movements/day
  • Bowel urgency
  • 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.

Other protocol-defined inclusion/exclusion criteria may apply.

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): NCT00394173

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Sponsors and Collaborators
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Study Chair: Novartis Pharmaceuticals Corp. NPC

Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00394173     History of Changes
Other Study ID Numbers: CDNK333B2202
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Keywords provided by Novartis:
gastrointestinal functional disorder
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases