Conditions: Chronic Idiopathic Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 376
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Elobixibat 10 mg/day arm 2: Elobixibat 5 mg/day arm 3: Placebo

Interventions: intervention 1: Elobixibat 10 mg intervention 2: Elobixibat 5 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Elobixibat 10 mg/day intervention 2: Elobixibat 5 mg/day intervention 3: Placebo

Protocol document: