Diarrhea Predominant Irritable Bowel Syndrome in Females
Public ClinicalTrials.gov record NCT00461526. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00461526
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 240 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2006 (Type not available)
- Primary completion
- Dec 2007 (Actual)
- Completion
- Dec 2007 (Actual)
- Last update posted
- Nov 25, 2019
2006 – 2007
United States locations
- U.S. sites
- 43
- U.S. states
- 22
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Associates, LLC | Huntsville | Alabama | 35801 | — |
| Radiant Research | Chandler | Arizona | 85225 | — |
| Genova Clinical Research | Tucson | Arizona | 85741 | — |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Community Clinical Trials | Orange | California | 92868 | — |
| Advanced Clinical Research Institute | Orange | California | 92869 | — |
| Medical Associates Research Group | San Diego | California | 92123 | — |
| Boulder Medical Center, PC | Boulder | Colorado | 80304 | — |
| Rocky Mountain Gastroenterology Associates | Thornton | Colorado | 80229 | — |
| Litchfield County Gastroenterology Associates, LLC | Torrington | Connecticut | 06790 | — |
| Washington Gastroenterology, PC | Washington D.C. | District of Columbia | 20010 | — |
| Consultants of Clinical Research of South Florida | Boynton Beach | Florida | 33436 | — |
| University Clinical Research - DeLand | DeLand | Florida | 32720 | — |
| Stedman Clinical Trials | Tampa | Florida | 33613 | — |
| Mount Vernon Clinical Research | Atlanta | Georgia | 30328 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| Digestive and Liver Disease Consultants, PC | Clive | Iowa | 50325 | — |
| Trover Center for Clinical Studies | Madisonville | Kentucky | 42431 | — |
| Maryland Digestive Disease Research | Laurel | Maryland | 20707 | — |
| Gastroenterology Associates | Jackson | Mississippi | 39202 | — |
| Toby Village Office Park | Pittsford | New York | 14534 | — |
| LeBauer Research Associates, PA | Greensboro | North Carolina | 27403 | — |
| Vital re:Search | Greensboro | North Carolina | 27408 | — |
| Bethany Medical Center | High Point | North Carolina | 27262 | — |
| Hanover Medical Specialist, PA | Wilmington | North Carolina | 28401 | — |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | — |
| Akron Gastroenterology Associates, Inc. | Akron | Ohio | 44302 | — |
| Research Solutions Corp. | Cincinnati | Ohio | 45220 | — |
| Gastrointestinal & Liver Disease Consultants | Dayton | Ohio | 45440 | — |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73104 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Grand View Medical Research | Sellersville | Pennsylvania | 18960 | — |
| Anderson Gastroenterology Associates, LLC | Anderson | South Carolina | 39621 | — |
| ClinSearch | Chattanooga | Tennessee | 37404 | — |
| Gastroenterology Center of the MidSouth, PC | Germantown | Tennessee | 37138 | — |
| Memphis Gastroenterology Group | Germantown | Tennessee | 38138 | — |
| The Jackson Clinic | Jackson | Tennessee | 38301 | — |
| Gastroenterology Associates | Kingsport | Tennessee | 37660 | — |
| Austin Gastroenterology, PA | Austin | Texas | 78745 | — |
| Trinity Clinic - Corsicana | Corsicana | Texas | 75110 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| Vantage Clinical Research Group | Olympia | Washington | 98506 | — |
| Northside Internal Medicine | Spokane | Washington | 99208 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00461526, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 25, 2019 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00461526 live on ClinicalTrials.gov.