Chronic Idiopathic Constipation
A double-blind, randomized, placebo-controlled, phase 3 trial in patients with chronic idiopathic constipation to demonstrate the efficacy and safety of elobixibat 5 mg and 10 mg for 26 weeks – Trial 000079, Echo 1
IRB# HUM00078625; This study is sponsored by Ferring Pharmaceticals.
Elobixibat interrupts the enterohepatic circulation of bile acids (BA) by decreasing intestinal BA reabsorption, which results in an increased BA load to the colon, which is expected to benefit patients with constipation.
A total of 840 patients will be included who meet the Rome III criteria for chronic idiopathic constipation will participate in this trial worldwide. Randomized subjects will receive one of three study drug treatments: 5 mg, 10 mg, 30 mg; and a fourth group will receive the placebo. Total participation is approximately 30 weeks and requires up to 11 visits. Interested participants may roll over to a one-year open-label extension study. Procedures include: physical exam, vital signs, EKG, and clinical lab tests.
- Male and female adults ages 18 years and older with chronic constipation
- Must have a colonoscopy (study will cover costs if no colonoscopy done in the past)
- Excluding lactating women or pregnant or planning on becoming pregnant while enrolled in the study
- Excluding subjects with chronic pancreatitis, active peptic ulcer, inflammatory bowel disease, history of bowel obstruction
- Excluding subjects with resection to part of the bowels (accepted is appendectomy, and cholecystectomy)
- Must stop taking other laxatives, narcotic pain medication, weight loss medication
Compensation: $50 per visit
Principal Investigator: Richard Saad, MD
Study Coordinator: Lina E-mail: LNahlawi@med.umich.edu, Telephone: (734) 936-2761