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