Chronic Idiopathic Constipation Clinical Trial
Official title:
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
Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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