8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230581
• Other study ID #: DDP225-04-006
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2005
• Last updated: October 12, 2007
• Start date: September 2005
• Est. completion date: August 2007

Study information

• Verified date: October 2007
• Source: Dynogen Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Drug:
• DDP225

Locations

Country	Name	City	State
Canada	QE II Health Sciences Centre	Halifax	Nova Scotia
Canada	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	Hopital St-Sacrement	Quebec
Canada	London Road Diagnostic Clinic	Sarnia	Ontario
Canada	Sarnia Institute of Clinical Research	Sarnia	Ontario
Canada	Canadian Phase Onward Inc.	Toronto	Ontario
Canada	Toronto Digestive Disease Associates, Inc.	Toronto	Ontario
United States	Long Island Gastrointestinal Research	Great Neck	New York
United States	Radiant Research	Greer	South Carolina
United States	Radiant Research	Mogadore	Ohio
United States	Radiant Research	Scottsdale	Arizona
United States	Radiant Research	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Dynogen Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI Transit
Secondary	Patient Reported Outcomes