Irritable Bowel SyndromePhase 2NCT00461526
Diarrhea Predominant Irritable Bowel Syndrome in Females
A Phase 2 study testing crofelemer in people with Irritable Bowel Syndrome, run by Bausch Health Americas, Inc. at 43 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- crofelemer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 43 sitesUnited States
- Study dates
- Oct 2006to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Serious medical or surgical conditions
- Colon Cancer, Crohns Disease or Ulcerative Colitis
- Pregnant or breast feeding
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Akron Gastroenterology Associates, Inc.
Akron, Ohio, 44302
Advanced Clinical Research Institute
Anaheim, California, 92801
Anderson Gastroenterology Associates, LLC
Anderson, South Carolina, 39621
Mount Vernon Clinical Research
Atlanta, Georgia, 30328
Austin Gastroenterology, PA
Austin, Texas, 78745
Boulder Medical Center, PC
Boulder, Colorado, 80304
Consultants of Clinical Research of South Florida
Boynton Beach, Florida, 33436
Radiant Research
Chandler, Arizona, 85225
ClinSearch
Chattanooga, Tennessee, 37404
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Research Solutions Corp.
Cincinnati, Ohio, 45220
Digestive and Liver Disease Consultants, PC
Clive, Iowa, 50325
Trinity Clinic - Corsicana
Corsicana, Texas, 75110
Gastrointestinal & Liver Disease Consultants
Dayton, Ohio, 45440
University Clinical Research - DeLand
DeLand, Florida, 32720
Gastroenterology Center of the MidSouth, PC
Germantown, Tennessee, 37138
Memphis Gastroenterology Group
Germantown, Tennessee, 38138
LeBauer Research Associates, PA
Greensboro, North Carolina, 27403
Vital re:Search
Greensboro, North Carolina, 27408
Bethany Medical Center
High Point, North Carolina, 27262
Clinical Research Associates, LLC
Huntsville, Alabama, 35801
Gastroenterology Associates
Jackson, Mississippi, 39202
The Jackson Clinic
Jackson, Tennessee, 38301
Gastroenterology Associates
Kingsport, Tennessee, 37660
Maryland Digestive Disease Research
Laurel, Maryland, 20707
Trover Center for Clinical Studies
Madisonville, Kentucky, 42431
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
Vantage Clinical Research Group
Olympia, Washington, 98506
Community Clinical Trials
Orange, California, 92868
Advanced Clinical Research Institute
Orange, California, 92869
Toby Village Office Park
Pittsford, New York, 14534
Medical Associates Research Group
San Diego, California, 92123
Grand View Medical Research
Sellersville, Pennsylvania, 18960
Northside Internal Medicine
Spokane, Washington, 99208
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Stedman Clinical Trials
Tampa, Florida, 33613
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, 80229
Litchfield County Gastroenterology Associates, LLC
Torrington, Connecticut, 06790
Genova Clinical Research
Tucson, Arizona, 85741
Washington Gastroenterology, PC
Washington D.C., District of Columbia, 20010
Hanover Medical Specialist, PA
Wilmington, North Carolina, 28401
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read more
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
Read the 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
- Conditions
- Irritable Bowel Syndrome
- Being tested
- crofelemer
- Keywords
- IBS, d-IBS, Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crofelemerDrug
125 mg crofelemer vs. placebo
| Study group | Role | What they receive |
|---|---|---|
| 125 mg crofelemer | Experimental | Not described Receives: Drug: crofelemer |
| placebo | Placebo comparator | Not described Receives: Drug: crofelemer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
Measured: March 2008
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
Measured: March 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461526
- Sponsor's protocol ID
- TRN-002-202
- Status last verified
- Nov 2019
- First submitted
- 9 Nov 2006
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nee J, Salley K, Ludwig AG, Sommers T, Ballou S, Takazawa E, Duehren S, Singh P, Iturrino J, Katon J, Lee HN, Rangan V, Lembo AJ. Randomized Clinical Trial: Crofelemer Treatment in Women With Diarrhea-Predominant Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2019 Dec;10(12):e00110. doi: 10.14309/ctg.0000000000000110.
PubMed 31800542
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00461526
- Acronym / sponsor ID
- TRN-002-202
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, d-IBS, Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 125 mg crofelemer | Experimental | Drug: crofelemer |
| placebo | Placebo comparator | Drug: crofelemer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Serious medical or surgical conditions
- Colon Cancer, Crohns Disease or Ulcerative Colitis
- Pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| crofelemer125 mg crofelemer vs. placebo | Drug | 125 mg crofelemer, placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Derived from this study: PubMed 31800542Nee J, Salley K, Ludwig AG, Sommers T, Ballou S, Takazawa E, Duehren S, Singh P, Iturrino J, Katon J, Lee HN, Rangan V, Lembo AJ. Randomized Clinical Trial: Crofelemer Treatment in Women With Diarrhea-Predominant Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2019 Dec;10(12):e00110. doi: 10.14309/ctg.0000000000000110.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing crofelemer in people with Irritable Bowel Syndrome, run by Bausch Health Americas, Inc. at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks. (time frame: March 2008). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00461526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.