Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268879
Status:
COMPLETED
Last Update Posted:
2008-02-15
First Post:
2005-12-22
Brief Title:
Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome IBS
Sponsor:
Alizyme
Organization:
Alizyme
Study Overview
Official Title:
A Phase III Multicenter Randomized Double-Blind Placebo-Controlled Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome c-IBS
Status:
COMPLETED
Status Verified Date:
2008-02
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:
The purpose of the study is to investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients
Detailed Description:
Irritable bowel syndrome IBS is a chronic gastrointestinal disorder characterized by recurrent symptoms of abdominal paindiscomfort accompanied by disturbed bowel function
In this study female patients with constipation predominant IBS will receive one of two dosing regimens of renzapride or placebo for 12 weeks Patients will record the severity of their symptoms throughout the study The results will be analysed to see if those patients who received renzapride had greater relief of their symptoms than did the patients who received placebo
In this study female patients with constipation predominant IBS will receive one of two dosing regimens of renzapride or placebo for 12 weeks Patients will record the severity of their symptoms throughout the study The results will be analysed to see if those patients who received renzapride had greater relief of their symptoms than did the patients who received placebo
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