8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS

• Sponsor: Dynogen Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00230581
• Collaborator: (none)
• Enrollment: 88
• Locations: 16
• Duration (Months): 23
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2005
• Actual Study Completion Date: Aug 1, 2007

Outcome Measures

Primary Outcome Measures

1. GI Transit []

Secondary Outcome Measures

1. Patient Reported Outcomes []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiant Research	Scottsdale	Arizona	United States	85251
2	Radiant Research	St. Louis	Missouri	United States	63141
3	Long Island Gastrointestinal Research	Great Neck	New York	United States	11023
4	Radiant Research	Mogadore	Ohio	United States	44260
5	Radiant Research	Greer	South Carolina	United States	29651
6	QE II Health Sciences Centre	Halifax	Nova Scotia	Canada
7	McMaster University Medical Centre	Hamilton	Ontario	Canada
8	St. Joseph's Healthcare	Hamilton	Ontario	Canada
9	Hotel Dieu Hospital	Kingston	Ontario	Canada
10	St. Joseph's Healthcare	London	Ontario	Canada
11	Meadowlands Family Health Centre	Ottawa	Ontario	Canada
12	London Road Diagnostic Clinic	Sarnia	Ontario	Canada
13	Sarnia Institute of Clinical Research	Sarnia	Ontario	Canada
14	Canadian Phase Onward Inc.	Toronto	Ontario	Canada	M3H 5S4
15	Toronto Digestive Disease Associates, Inc.	Toronto	Ontario	Canada
16	Hopital St-Sacrement	Quebec		Canada

Sponsors and Collaborators

• Dynogen Pharmaceuticals

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00230581
• Other Study ID Numbers: DDP225-04-006
• First Posted: Oct 3, 2005
• Last Update Posted: Oct 15, 2007
• Last Verified: Oct 1, 2007

• Keywords provided by , ,: IBS-d, IBS
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea

Study Results

No Results Posted as of Oct 15, 2007