Irritable Bowel SyndromePhase 2NCT00101725
A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
A Phase 2 study testing crofelemer in people with Irritable Bowel Syndrome and Colonic Diseases, run by Bausch Health Americas, Inc. at 29 sites in United States.
Trial summary
This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Colonic Diseases, Diarrhea
- What is being tested?
- crofelemer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 29 sitesUnited States
- Study dates
- Dec 2004to Nov 2005
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 since your IBS diagnosis and in the past 5 years
- Willingness to use an approved method of birth control
Who cannot join
- Serious medical or surgical conditions
- Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
- Pregnancy or breast feeding
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
AGMG Clinical Research Institute
Anaheim, California, 92801
Anderson Gastroenterology
Anderson, South Carolina, 29621
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, 33426
TriCities Medical Research
Bristol, Tennessee, 37620
Radiant Research Phoenix Southeast
Chandler, Arizona, 85225
ClinSearch
Chattanooga, Tennessee, 37404
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Radient Research
Columbus, Ohio, 43212
Radiant Research Dallas-North
Dallas, Texas, 75231
University Clinical Research DeLand
DeLand, Florida, 32720
LeBauer Research Associates, PA
Greensboro, North Carolina, 27403
Medoff Medical / Vital Research
Greensboro, North Carolina, 27408
Clinical Research Associates
Huntsville, Alabama, 35801
CRC of Jakson
Jackson, Mississippi, 39202
Jackson Clinic
Jackson, Tennessee, 38301
Memphis Gastroenterology
Memphis, Tennessee, 38120
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
Community Clinical Trials
Orange, California, 92868
AGMG Clinical Research
Orange, California, 92869
nTouch Research
Peoria, Illinois, 61602
Tobey Village Office Park
Pittsford, New York, 14534
Synergy Medical Education Alliance
Saginaw, Michigan, 48602
Institute of Healthcare Assessment, Inc.
San Diego, California, 92120
Grandview Medical Research, Inc
Sellersville, Pennsylvania, 18960
Mercy Medical Group
St Louis, Missouri, 63141
Tacoma Digestive Disease Research Center
Tacoma, Washington, 98405
Washington Gastroenterology
Washington D.C., District of Columbia, 20010
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401
Piedmont Medical Research Assoc., Inc.
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)
This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).
Read the detailed description
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 who are eligible to participate will have a 75% chance of receiving TRN-002 and a 25% chance of receiving placebo (a substance that looks similar to TRN 002 but has no activity). Subjects will not be able to remain on certain standard IBS medications (antidiarrheals) while participating in the study. The total duration is 16 weeks.
The study requires five study visits that include physical exams, ECG and blood draws for laboratory studies. A colon procedure (such as a colonoscopy or flexible sigmoidoscopy) may also be required if it has not been performed since your diagnosis and within the last 5 years. Participants will be asked to make daily entries into a touch-tone telephone diary on a daily basis.
- Being tested
- crofelemer
- Keywords
- Diarrhea, IBS, Irritable Bowel Syndrome, Abdominal pain
- Medical subject headings
- Irritable Bowel Syndrome, Colonic Diseases, Diarrhea, Gastrointestinal Diseases, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crofelemerDrug
| Study group | Role | What they receive |
|---|---|---|
| 125 mg crofelemer | Experimental | Not described Receives: Drug: crofelemer |
| 250 mg crofelemer | Experimental | Not described Receives: Drug: crofelemer |
| 500 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.
Secondary outcomes (1)
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2005 (estimated)
- Study startDec 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101725
- Sponsor's protocol ID
- TRN 002 201
- Status last verified
- Nov 2019
- First submitted
- 12 Jan 2005
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
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)
- ClinicalTrials.gov ID
- NCT00101725
- Acronym / sponsor ID
- TRN 002 201
- Keywords
- Diarrhea, IBS, Irritable Bowel Syndrome, Abdominal pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 13 Jan 2005 (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.
This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).
Detailed description
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 who are eligible to participate will have a 75% chance of receiving TRN-002 and a 25% chance of receiving placebo (a substance that looks similar to TRN 002 but has no activity). Subjects will not be able to remain on certain standard IBS medications (antidiarrheals) while participating in the study. The total duration is 16 weeks.
The study requires five study visits that include physical exams, ECG and blood draws for laboratory studies. A colon procedure (such as a colonoscopy or flexible sigmoidoscopy) may also be required if it has not been performed since your diagnosis and within the last 5 years. Participants will be asked to make daily entries into a touch-tone telephone diary on a daily basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 125 mg crofelemer | Experimental | Drug: crofelemer |
| 250 mg crofelemer | Experimental | Drug: crofelemer |
| 500 mg crofelemer | Experimental | Drug: crofelemer |
| placebo | Placebo comparator | Drug: crofelemer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 since your IBS diagnosis and in the past 5 years
- Willingness to use an approved method of birth control
Key exclusion criteria (3 listed)
- Serious medical or surgical conditions
- Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
- Pregnancy 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 |
|---|---|---|
| crofelemer | Drug | 125 mg crofelemer, 250 mg crofelemer, 500 mg crofelemer, placebo |
Primary outcome
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
1 secondary outcome
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
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.
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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.
29 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 and Colonic Diseases, run by Bausch Health Americas, Inc. at 29 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 4 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 29 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.