Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252993
Status:
TERMINATED
Last Update Posted:
2007-10-12
First Post:
2005-11-11
Brief Title:
12 Weeks Treatment With DDP225 or Placebo in Patients With Chronic Functional Vomiting
Sponsor:
Dynogen Pharmaceuticals
Organization:
Dynogen Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of DDP225 in Patients With Chronic Functional Vomiting
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 heshe 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
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 heshe 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None