NCT01833065

Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation

A Double-blind, Randomised, 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 12 Weeks Followed by a 4-week Withdrawal Period

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation.

Detailed description

The present trial was designed to determine the efficacy and safety of elobixibat treatment (at both doses of 5 mg and 10 mg/day) compared to placebo treatment for 12-week Treatment Period followed by a 4-week Withdrawal Period in patients with chronic idiopathic constipation. During Withdrawal Period a sub-group of patients in elobixibat 5 mg and 10 mg treatment arms respectively received placebo treatment, while rest of the patients continued with 5 mg and 10 mg treatment in respective groups. In placebo groups, patients received elobixibat 10 mg treatment during Withdrawal Period. Patients were followed-up for 2 weeks after end of the Withdrawal Period. The assessment of primary and key secondary end points was done for patients who completed the first 12 weeks of treatment period. Incidence of Adverse Events (AEs) were reported till 2 weeks after end of the Withdrawal Period. The trial was early terminated due to a distribution issue with the trial medication.

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DRUG	Elobixibat 10 mg/day	Elobixibat 10 mg/day
DRUG	Elobixibat 5 mg/day	Elobixibat 5 mg/day
DRUG	Placebo	Placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2013-04-16
• Last updated: 2015-10-20
• Results posted: 2015-10-20

Locations

97 sites across 12 countries: United States, Brazil, Canada, Czechia, Germany, Hungary, Mexico, Poland, Slovakia, South Africa, Sweden, United Kingdom