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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.

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: crofelemer Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Crofelemer

Arm Intervention/treatment
Experimental: 125 mg crofelemer Drug: crofelemer
125 mg crofelemer vs. placebo

Placebo Comparator: placebo Drug: crofelemer
125 mg crofelemer vs. placebo




Primary Outcome Measures :
  1. To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks. [ Time Frame: March 2008 ]
  2. To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks. [ Time Frame: March 2008 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461526


  Hide Study Locations
Locations
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United States, Alabama
Clinical Research Associates, LLC
Huntsville, Alabama, United States, 35801
United States, Arizona
Radiant Research
Chandler, Arizona, United States, 85225
Genova Clinical Research
Tucson, Arizona, United States, 85741
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Community Clinical Trials
Orange, California, United States, 92868
Advanced Clinical Research Institute
Orange, California, United States, 92869
Medical Associates Research Group
San Diego, California, United States, 92123
United States, Colorado
Boulder Medical Center, PC
Boulder, Colorado, United States, 80304
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, United States, 80229
United States, Connecticut
Litchfield County Gastroenterology Associates, LLC
Torrington, Connecticut, United States, 06790
United States, District of Columbia
Washington Gastroenterology, PC
Washington, District of Columbia, United States, 20010
United States, Florida
Consultants of Clinical Research of South Florida
Boynton Beach, Florida, United States, 33436
University Clinical Research - DeLand
DeLand, Florida, United States, 32720
Stedman Clinical Trials
Tampa, Florida, United States, 33613
United States, Georgia
Mount Vernon Clinical Research
Atlanta, Georgia, United States, 30328
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Iowa
Digestive and Liver Disease Consultants, PC
Clive, Iowa, United States, 50325
United States, Kentucky
Trover Center for Clinical Studies
Madisonville, Kentucky, United States, 42431
United States, Maryland
Maryland Digestive Disease Research
Laurel, Maryland, United States, 20707
United States, Mississippi
Gastroenterology Associates
Jackson, Mississippi, United States, 39202
United States, New York
Toby Village Office Park
Pittsford, New York, United States, 14534
United States, North Carolina
LeBauer Research Associates, PA
Greensboro, North Carolina, United States, 27403
Vital re:Search
Greensboro, North Carolina, United States, 27408
Bethany Medical Center
High Point, North Carolina, United States, 27262
Hanover Medical Specialist, PA
Wilmington, North Carolina, United States, 28401
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Akron Gastroenterology Associates, Inc.
Akron, Ohio, United States, 44302
Research Solutions Corp.
Cincinnati, Ohio, United States, 45220
Gastrointestinal & Liver Disease Consultants
Dayton, Ohio, United States, 45440
United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Grand View Medical Research
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Anderson Gastroenterology Associates, LLC
Anderson, South Carolina, United States, 39621
United States, Tennessee
ClinSearch
Chattanooga, Tennessee, United States, 37404
Gastroenterology Center of the MidSouth, PC
Germantown, Tennessee, United States, 37138
Memphis Gastroenterology Group
Germantown, Tennessee, United States, 38138
The Jackson Clinic
Jackson, Tennessee, United States, 38301
Gastroenterology Associates
Kingsport, Tennessee, United States, 37660
United States, Texas
Austin Gastroenterology, PA
Austin, Texas, United States, 78745
Trinity Clinic - Corsicana
Corsicana, Texas, United States, 75110
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
United States, Washington
Vantage Clinical Research Group
Olympia, Washington, United States, 98506
Northside Internal Medicine
Spokane, Washington, United States, 99208
Sponsors and Collaborators
Bausch Health Americas, Inc.

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Responsible Party: Michelle Widmann, Associate Director, Clinical Operations, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00461526     History of Changes
Other Study ID Numbers: TRN-002-202
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: November 22, 2010
Last Verified: November 2010
Keywords provided by Bausch Health Americas, Inc.:
IBS
d-IBS
Irritable Bowel Syndrome
Additional relevant MeSH terms:
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Colonic Diseases, Functional
Colonic Diseases
Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases