8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS

This study has been completed.
Sponsor:
Information provided by:
Dynogen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00230581
First received: September 29, 2005
Last updated: October 12, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome
Drug: DDP225
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Dynogen Pharmaceuticals:

Primary Outcome Measures:
  • GI Transit

Secondary Outcome Measures:
  • Patient Reported Outcomes

Estimated Enrollment: 88
Study Start Date: September 2005
Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230581

Locations
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
St. Joseph's Healthcare
Hamilton, Ontario, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
Hotel Dieu Hospital
Kingston, Ontario, Canada
St. Joseph's Healthcare
London, Ontario, Canada
Meadowlands Family Health Centre
Ottawa, Ontario, Canada
Sarnia Institute of Clinical Research
Sarnia, Ontario, Canada
London Road Diagnostic Clinic
Sarnia, Ontario, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, Canada, M3H 5S4
Toronto Digestive Disease Associates, Inc.
Toronto, Ontario, Canada
Canada
Hopital St-Sacrement
Quebec, Canada
Sponsors and Collaborators
Dynogen Pharmaceuticals
Investigators
Study Chair: William Patterson, MD Hotel Dieu Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00230581     History of Changes
Other Study ID Numbers: DDP225-04-006
Study First Received: September 29, 2005
Last Updated: October 12, 2007
Health Authority: Canada: Health Canada

Keywords provided by Dynogen Pharmaceuticals:
IBS-d, IBS

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 20, 2014