Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230581
Status:
COMPLETED
Last Update Posted:
2007-10-15
First Post:
2005-09-29
Brief Title:
8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS
Sponsor:
Dynogen Pharmaceuticals
Organization:
Dynogen Pharmaceuticals
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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