8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS

October 12, 2007 updated by: Dynogen Pharmaceuticals

A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP225 in Female Patients With Irritable Bowel Syndrome With Diarrhea

In this study, female patients with IBS-d will be treated for 8 weeks to assess the safety and effectiveness of DDP225 on GI transit and in reducing IBS symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo controlled, multicenter study designed to assess the safety and efficacy of DDP225 in patients with IBS-d. Female patients from 18 to 65 years of age with a history of IBS-d for at least 6 months are potentially eligible for entry into the study. A total of 88 eligible patients with IBS-d will be studied.

The total duration of study participation for an individual patient is approximately 10 weeks (74 days) from the initial screening visit to final study evaluations. The total duration of dosing with study medication (either DDP225 or placebo) is 8 weeks.

Patients who satisfy all of the inclusion criteria and none of the exclusion criteria are eligible to enter the Treatment Period and will be randomly assigned to one of four treatment groups.

After a patient is randomized and enters the Treatment Period, she will take the appropriate study medication once a day for 56 days and return to the clinic at two week intervals for a total of four visits during the Treatment Period. During the Treatment Period, patients will maintain a daily diary and complete questionnaires. One week after completing the 56-day Treatment Period, patients return to the clinic for final safety evaluations which include a physical examination, electrocardiogram, and clinical laboratory testing.

Study Type

Interventional

Enrollment (Anticipated)

88

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
        • Hopital St-Sacrement
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • QE II Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada
        • St. Joseph's Healthcare
      • Hamilton, Ontario, Canada
        • McMaster University Medical Centre
      • Kingston, Ontario, Canada
        • Hotel Dieu Hospital
      • London, Ontario, Canada
        • St. Joseph's Healthcare
      • Ottawa, Ontario, Canada
        • Meadowlands Family Health Centre
      • Sarnia, Ontario, Canada
        • London Road Diagnostic Clinic
      • Sarnia, Ontario, Canada
        • Sarnia Institute of Clinical Research
      • Toronto, Ontario, Canada, M3H 5S4
        • Canadian Phase Onward Inc.
      • Toronto, Ontario, Canada
        • Toronto Digestive Disease Associates, Inc.
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Radiant Research
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Radiant Research
    • New York
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research
    • Ohio
      • Mogadore, Ohio, United States, 44260
        • Radiant Research
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Radiant Research

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients from 18 to 65 years of age, inclusive.
  2. History of IBS-d for at least 6 months prior to the initial screening visit.
  3. Endoscopic/radiologic bowel evaluation to rule out cancer, obstruction, or other structural disease.
  4. The patient must have completed at least six days of assessments in the patient diary in the one week period prior to the second screening visit.
  5. Negative serum and urine pregnancy tests and post-partum for at least one year or not breast feeding at the initial screening visit and throughout the study. For patients able to bear children, an acceptable method of birth control must be used throughout the study. Patients unable to bear children must have documentation of such in the case report form (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
  6. Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol.

Exclusion Criteria:

  1. Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel transit including biochemical or structural abnormalities, or GI surgery
  2. Clinically significant abnormal examination findings or laboratory tests
  3. Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which could interfere with study assessments
  4. Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
  5. Presence of a medical condition which could interfere with the interpretation of study data
  6. Significant use of nicotine or caffeine

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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
GI Transit

Secondary Outcome Measures

Outcome Measure
Patient Reported Outcomes

Collaborators and Investigators

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

Sponsor

Dynogen Pharmaceuticals

Investigators

  • Study Chair: William Patterson, MD, Hotel Dieu Hospital

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, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 29, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (Estimate)

October 3, 2005

Study Record Updates

Last Update Posted (Estimate)

October 15, 2007

Last Update Submitted That Met QC Criteria

October 12, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDP225-04-006

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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