8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS

Launched by DYNOGEN PHARMACEUTICALS · Sep 29, 2005

Keywords

ClinConnect Summary

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...

Gender

FEMALE

Eligibility 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

Trial Officials