NCT01827592

26 Week Efficacy and Safety Trial for 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 26 Weeks

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks.

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 26-week Treatment Period in patients with chronic idiopathic constipation. Patients were followed-up for 2 weeks after end of the Treatment 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 treatment. 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	Elobixibat 10 mg/day
DRUG	Elobixibat 5 mg	Elobixibat 5 mg/day
DRUG	Placebo	Placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-03-01
• Completion: 2014-05-01
• First posted: 2013-04-09
• Last updated: 2015-10-20
• Results posted: 2015-10-20

Locations

94 sites across 10 countries: United States, Belgium, Brazil, Canada, Czechia, Germany, Israel, Poland, South Africa, United Kingdom