Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461526
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2006-11-09
Brief Title:
Diarrhea Predominant Irritable Bowel Syndrome in Females
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 in Females
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:
Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome IBS
The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome 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 will be not able to remain on certain standard IBS medications anti-diarrheals while participating in the study The total duration of the study is 18 weeks
The study requires five study visits that include physical exams ECG blood draws laboratory studies and a colon procedure such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years Participants will be asked to make entries into a touch-tone telephone diary on a daily basis
Participants must meet all of the following criteria
Females at least 18 years of age
Diagnosis of diarrhea predominant Irritable Bowel Syndrome
Willingness to make daily calls on a touch-tone telephone
Willingness to have an endoscopic andor radiologic bowel evaluation if you have not received one in the past 5 years
Willingness to take an approved method of birth control if required
Participants CANNOT meet any of the following criteria
Serious medical or surgical conditions
Colon Cancer Crohns Disease or Ulcerative Colitis
Pregnant or breast feeding
The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome 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 will be not able to remain on certain standard IBS medications anti-diarrheals while participating in the study The total duration of the study is 18 weeks
The study requires five study visits that include physical exams ECG blood draws laboratory studies and a colon procedure such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years Participants will be asked to make entries into a touch-tone telephone diary on a daily basis
Participants must meet all of the following criteria
Females at least 18 years of age
Diagnosis of diarrhea predominant Irritable Bowel Syndrome
Willingness to make daily calls on a touch-tone telephone
Willingness to have an endoscopic andor radiologic bowel evaluation if you have not received one in the past 5 years
Willingness to take an approved method of birth control if required
Participants CANNOT meet any of the following criteria
Serious medical or surgical conditions
Colon Cancer Crohns Disease or Ulcerative Colitis
Pregnant or breast feeding
Detailed Description:
Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome IBS
The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome 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 will be not able to remain on certain standard IBS medications anti-diarrheals while participating in the study The total duration of the study is 18 weeks
The study requires five study visits that include physical exams ECG blood draws laboratory studies and a colon procedure such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years Participants will be asked to make entries into a touch-tone telephone diary on a daily basis
Participants must meet all of the following criteria
Females at least 18 years of age
Diagnosis of diarrhea predominant Irritable Bowel Syndrome
Willingness to make daily calls on a touch-tone telephone
Willingness to have an endoscopic andor radiologic bowel evaluation if you have not received one in the past 5 years
Willingness to take an approved method of birth control if required
Participants CANNOT meet any of the following criteria
Serious medical or surgical conditions
Colon Cancer Crohns Disease or Ulcerative Colitis
Pregnant or breast feeding
The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome 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 will be not able to remain on certain standard IBS medications anti-diarrheals while participating in the study The total duration of the study is 18 weeks
The study requires five study visits that include physical exams ECG blood draws laboratory studies and a colon procedure such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years Participants will be asked to make entries into a touch-tone telephone diary on a daily basis
Participants must meet all of the following criteria
Females at least 18 years of age
Diagnosis of diarrhea predominant Irritable Bowel Syndrome
Willingness to make daily calls on a touch-tone telephone
Willingness to have an endoscopic andor radiologic bowel evaluation if you have not received one in the past 5 years
Willingness to take an approved method of birth control if required
Participants CANNOT meet any of the following criteria
Serious medical or surgical conditions
Colon Cancer Crohns Disease or Ulcerative Colitis
Pregnant or breast feeding
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