Conditions: Chronic Idiopathic Constipation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 411
Healthy volunteers: no

Brief 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).

Arms:
arm 1: Elobixibat 10 mg

Interventions: intervention 1: Elobixibat 10 mg
Intervention descriptions: intervention 1: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.

Protocol document: