Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101725
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2005-01-12
Brief Title:
A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Assess the Safety and Efficacy of TRN 002 Crofelemer for the Symptomatic Treatment of Diarrhea-Predominant Irritable Bowel Syndrome d-IBS
Status:
COMPLETED
Status Verified Date:
2019-11
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:
This study is designed to evaluate the safety and effectiveness of an investigational drug TRN-002 crofelemer to relieve the symptoms of diarrhea-predominant irritable bowel syndrome IBS
Detailed Description:
The investigational drug is a natural product taken from a plant that grows in South America The study medication will be administered orally twice a day Subjects who are eligible to participate will have a 75 chance of receiving TRN-002 and a 25 chance of receiving placebo a substance that looks similar to TRN 002 but has no activity Subjects will not be able to remain on certain standard IBS medications antidiarrheals while participating in the study The total duration is 16 weeks
The study requires five study visits that include physical exams ECG and blood draws for laboratory studies A colon procedure such as a colonoscopy or flexible sigmoidoscopy may also be required if it has not been performed since your diagnosis and within the last 5 years Participants will be asked to make daily entries into a touch-tone telephone diary on a daily basis
The study requires five study visits that include physical exams ECG and blood draws for laboratory studies A colon procedure such as a colonoscopy or flexible sigmoidoscopy may also be required if it has not been performed since your diagnosis and within the last 5 years Participants will be asked to make daily entries into a touch-tone telephone diary on a daily basis
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