Conditions: Chronic Idiopathic Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 314
Healthy volunteers: no

Brief 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.

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

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

Protocol document: