NCT01895543

Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

A Multicenter, Open-label, Safety and Tolerability Extension Trial of 5 mg and 10 mg Elobixibat Daily in the Treatment of Chronic Idiopathic Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 411 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC)

Detailed description

This was a Phase 3 multicenter, open-label, safety and tolerability extension trial of 10 mg elobixibat daily, with possibility for dose adjustment to 5 mg daily, for 52-week Treatment Period in patients with CIC. A dose adjustment to 5 mg/day was allowed for the remainder of the trial if a patient reported unacceptable treatment-related diarrhoea that occurred within the first four weeks of treatment. The trial enrolled patients from two lead-in, double-blind efficacy trials (trial codes NCT01827592 and NCT01833065).

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DRUG	Elobixibat 10 mg	10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-07-10
• Last updated: 2016-05-09
• Results posted: 2016-05-09

Locations

62 sites across 10 countries: United States, Belgium, Canada, Czechia, Hungary, Poland, Slovakia, South Africa, Sweden, United Kingdom