Status:
COMPLETED
8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS
Lead Sponsor:
Dynogen Pharmaceuticals
Conditions:
Irritable Bowel Syndrome
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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.
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...
Eligibility Criteria
Inclusion
- Female patients from 18 to 65 years of age, inclusive.
- History of IBS-d for at least 6 months prior to the initial screening visit.
- Endoscopic/radiologic bowel evaluation to rule out cancer, obstruction, or other structural disease.
- 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.
- 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 \[defined as a minimum of one year since the last menstrual period\]).
- Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol.
Exclusion
- Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel transit including biochemical or structural abnormalities, or GI surgery
- Clinically significant abnormal examination findings or laboratory tests
- Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which could interfere with study assessments
- Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
- Presence of a medical condition which could interfere with the interpretation of study data
- Significant use of nicotine or caffeine
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00230581
Start Date
September 1 2005
End Date
August 1 2007
Last Update
October 15 2007
Active Locations (16)
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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