8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS

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: NCT00230581
Recruitment Status : Completed
First Posted : October 3, 2005
Last Update Posted : October 15, 2007
Information provided by:
Dynogen Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: DDP225 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Primary Outcome Measures :
  1. GI Transit

Secondary Outcome Measures :
  1. Patient Reported Outcomes

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
Accepts Healthy Volunteers:   No

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

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): NCT00230581

United States, Arizona
Radiant Research
Scottsdale, Arizona, United States, 85251
United States, Missouri
Radiant Research
St. Louis, Missouri, United States, 63141
United States, New York
Long Island Gastrointestinal Research
Great Neck, New York, United States, 11023
United States, Ohio
Radiant Research
Mogadore, Ohio, United States, 44260
United States, South Carolina
Radiant Research
Greer, South Carolina, United States, 29651
Canada, Nova Scotia
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Hotel Dieu Hospital
Kingston, Ontario, Canada
St. Joseph's Healthcare
London, Ontario, Canada
Meadowlands Family Health Centre
Ottawa, Ontario, Canada
London Road Diagnostic Clinic
Sarnia, Ontario, Canada
Sarnia Institute of Clinical Research
Sarnia, Ontario, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, Canada, M3H 5S4
Toronto Digestive Disease Associates, Inc.
Toronto, Ontario, Canada
Hopital St-Sacrement
Quebec, Canada
Sponsors and Collaborators
Dynogen Pharmaceuticals
Study Chair: William Patterson, MD Hotel Dieu Hospital Identifier: NCT00230581     History of Changes
Other Study ID Numbers: DDP225-04-006
First Posted: October 3, 2005    Key Record Dates
Last Update Posted: October 15, 2007
Last Verified: October 2007

Keywords provided by Dynogen Pharmaceuticals:

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