A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Disease; Irritable Bowel Syndrome; Diarrhea; Colonic Diseases

Treatments: Drug: crofelemer

Study type: Interventional

Funder types: Industry

Identifiers

NCT00101725

TRN 002 201

Details and patient eligibility

About

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).

Full 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.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Serious medical or surgical conditions
• Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
• Pregnancy or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

245 participants in 4 patient groups, including a placebo group

125 mg crofelemer

Experimental group

Treatment:

Drug: crofelemer

250 mg crofelemer

Experimental group

Treatment:

Drug: crofelemer

500 mg crofelemer

Experimental group

Treatment:

Drug: crofelemer

placebo

Placebo Comparator group

Treatment:

Drug: crofelemer