Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

Novartis

Conditions:

Irritable Bowel Syndrome With Diarrhea (IBS-D)

Eligibility:

FEMALE

18-65 years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    September 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2007

    Estimated Enrollment :

    180 Patients enrolled

    Trial Details

    Trial ID

    NCT00394173

    Start Date

    September 1 2006

    End Date

    October 1 2007

    Last Update

    February 27 2017

    Active Locations (43)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 11 (43 locations)

    1

    Investigative Site

    Tucson, Arizona, United States, 85712

    2

    Investigative Site

    North Little Rock, Arkansas, United States, 72114

    3

    Investigative Site

    Los Angeles, California, United States, 90045-3119

    4

    Investigative Site

    Orange, California, United States, 92869