12 Weeks Treatment With DDP225 or Placebo in Patients With Chronic Functional Vomiting
Status:
Terminated
Trial end date:
2006-03-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double blind, placebo controlled, multicenter study designed to assess
the safety and efficacy of DDP225 in patients with chronic functional vomiting. Male or
female patients from 18 to 65 years of age with a functional vomiting history for at least 12
weeks in the preceding 12 months or cyclic vomiting history with at least 3 episodes in the
previous 12 months are eligible. A total of 30 eligible patients with chronic functional
vomiting will be enrolled.
The total duration of study participation for an individual patient is approximately 15 weeks
(105 days) from the initial screening visit to final study evaluations. The total duration of
dosing with study medication (either DDP225 or placebo) is 12 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 three
treatment groups.
After a patient is randomized and enters the Treatment Period, he/she will take the
appropriate study medication once a day for 84 days and return to the clinic at two week
intervals for a total of six visits during the Treatment Period. During the Treatment Period,
patients will maintain a daily diary and complete questionnaires. One week after completing
the 84-day Treatment Period, patients return to the clinic for final safety evaluations which
include a physical examination, electrocardiogram, and clinical laboratory testing.