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Trial record 45 of 54 for:    colon cancer | ( Map: Mississippi, United States )

Diarrhea Predominant Irritable Bowel Syndrome in Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00461526
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : November 22, 2010
Sponsor:
Information provided by:
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE November 9, 2006
First Posted Date  ICMJE April 18, 2007
Last Update Posted Date November 22, 2010
Study Start Date  ICMJE October 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks. [ Time Frame: March 2008 ]
  • To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks. [ Time Frame: March 2008 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2007)
  • To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
  • To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
Change History Complete list of historical versions of study NCT00461526 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diarrhea Predominant Irritable Bowel Syndrome in Females
Official Title  ICMJE 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
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 and/or 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 and/or 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE Drug: crofelemer
125 mg crofelemer vs. placebo
Study Arms  ICMJE
  • Experimental: 125 mg crofelemer
    Intervention: Drug: crofelemer
  • Placebo Comparator: placebo
    Intervention: Drug: crofelemer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2007)
240
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion 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 and/or 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)

Exclusion Criteria:

  • Serious medical or surgical conditions
  • Colon Cancer, Crohns Disease or Ulcerative Colitis
  • Pregnant or breast feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00461526
Other Study ID Numbers  ICMJE TRN-002-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michelle Widmann, Associate Director, Clinical Operations, Salix Pharmaceuticals
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bausch Health Americas, Inc.
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP