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

February 23, 2017 updated by: Novartis

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)

The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1S 4L8
        • Investigative Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Investigative Site
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1E 2E2
        • Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • Investigative Site
      • Sherbrooke, Quebec, Canada, J1H 4J6
        • Investigative Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Investigative Site
    • Arkansas
      • North Little Rock, Arkansas, United States, 72114
        • Investigative Site
    • California
      • Los Angeles, California, United States, 90045-3119
        • Investigative Site
      • Orange, California, United States, 92869
        • Investigative Site
      • Riverside, California, United States, 92506
        • Investigative Site
      • Sacramento, California, United States, 95825
        • Investigative Site
      • San Diego, California, United States, 92108
        • Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Investigative Site
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Investigative Site
      • Hartford, Connecticut, United States, 06010
        • Investigative Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Investigative Site
      • Gainesville, Florida, United States, 32256
        • Investigative Site
      • Hollywood, Florida, United States, 33021
        • Investigative Site
      • Jacksonville, Florida, United States, 782091744
        • Investigative Site
      • Miami, Florida, United States, 33173
        • Investigative Site
      • New Smyrna Beach, Florida, United States, 32168-7327
        • Investigative Site
      • Tampa, Florida, United States, 33607
        • Investigative Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Investigative Site
      • Rockford, Illinois, United States, 61107
        • Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Investigative Site
      • Wellesley Hills, Massachusetts, United States, 02481-2106
        • Investigative Site
    • Missouri
      • Mexico, Missouri, United States, 65265-3726
        • Investigative Site
    • New York
      • Buffalo, New York, United States, 14215
        • Investigative Site
      • Great Neck, New York, United States, 11023-2432
        • Investigative Site
    • North Carolina
      • Elkin, North Carolina, United States, 28621
        • Investigative Site
    • Ohio
      • Cincinatti, Ohio, United States, 45219
        • Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97220
        • Investigative Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Investigative Site
    • Texas
      • Lake Jackson, Texas, United States, 77566
        • Investigative Site
      • San Antonio, Texas, United States, 78209-1744
        • Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Investigative Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320-1706
        • Investigative Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Investigative Site
      • Everett, Washington, United States, 98208
        • Investigative Site
      • Monroe, Washington, United States, 98208
        • Investigative Site
      • Seattle, Washington, United States, 98101
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
Matching placebo
EXPERIMENTAL: 1
Drug: DNK333
DNK333 25mg b.i.d. given orally for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Satisfactory relief of IBS-related abdominal pain/discomfort
Time Frame: 4 weeks
4 weeks
Satisfactory relief of overall IBS-D symptoms
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in stool frequency
Time Frame: 4 weeks
4 weeks
Occurrence and control of bowel urgency
Time Frame: 4 weeks
4 weeks
Severity of abdominal bloating
Time Frame: 4 weeks
4 weeks
Severity of abdominal pain/discomfort
Time Frame: 4 weeks
4 weeks
Safety
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

October 30, 2006

First Submitted That Met QC Criteria

October 30, 2006

First Posted (ESTIMATE)

October 31, 2006

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDNK333B2202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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