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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Irritable Bowel Syndrome

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.

Outcome Time Frame:

March 2008

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

TRN-002-202

NCT ID:

NCT00461526

Start Date:

October 2006

Completion Date:

December 2007

Related Keywords:

  • Irritable Bowel Syndrome
  • IBS
  • d-IBS
  • Irritable Bowel Syndrome
  • Diarrhea
  • Irritable Bowel Syndrome

Name

Location

Advanced Clinical Research InstituteAnaheim, California  92801
Piedmont Medical Research AssociatesWinston Salem, North Carolina  27103
Radiant Research7042 East Broadway Tucson, Arizona  85710
Stedman Clinical TrialsTampa, Florida  33647
Maryland Digestive Disease ResearchLaurel, Maryland  20707
Memphis Gastroenterology GroupGermantown, Tennessee  38138
Austin Gastroenterology, PaAustin, Texas  78705
Clinical Research Associates, LLCHuntsville, Alabama  35801
Genova Clinical ResearchTucson, Arizona  85741
Community Clinical TrialsOrange, California  92868
Medical Associates Research GroupSan Diego, California  92123
Boulder Medical Center, PCBoulder, Colorado  80304
Rocky Mountain Gastroenterology AssociatesThornton, Colorado  80229
Litchfield County Gastroenterology Associates, LLCTorrington, Connecticut  06790
Washington Gastroenterology, PCWashington, District of Columbia  20010
Consultants of Clinical Research of South FloridaBoynton Beach, Florida  33436
University Clinical Research - DeLandDeLand, Florida  32720
Mount Vernon Clinical ResearchAtlanta, Georgia  30328
Clinical Research AtlantaStockbridge, Georgia  30281
Digestive and Liver Disease Consultants, PCClive, Iowa  50325
Trover Center for Clinical StudiesMadisonville, Kentucky  42431
Gastroenterology AssociatesJackson, Mississippi  39202
Toby Village Office ParkPittsford, New York  14534
LeBauer Research Associates, PAGreensboro, North Carolina  27403
Vital re:SearchGreensboro, North Carolina  27408
Bethany Medical CenterHigh Point, North Carolina  27262
Hanover Medical Specialist, PAWilmington, North Carolina  28401
Akron Gastroenterology Associates, Inc.Akron, Ohio  44302
Research Solutions Corp.Cincinnati, Ohio  45220
Gastrointestinal & Liver Disease ConsultantsDayton, Ohio  45440
Sooner Clinical ResearchOklahoma City, Oklahoma  73112
Oklahoma Foundation for Digestive ResearchOklahoma City, Oklahoma  73104
Grand View Medical ResearchSellersville, Pennsylvania  18960
Anderson Gastroenterology Associates, LLCAnderson, South Carolina  39621
ClinSearchChattanooga, Tennessee  37404
Gastroenterology Center of the MidSouth, PCGermantown, Tennessee  37138
The Jackson ClinicJackson, Tennessee  38301
Gastroenterology AssociatesKingsport, Tennessee  37660
Trinity Clinic - CorsicanaCorsicana, Texas  75110
Gastroenterology Associates of TidewaterChesapeake, Virginia  23320
Vantage Clinical Research GroupOlympia, Washington  98506
Northside Internal MedicineSpokane, Washington  99208