NCT04784780

Long-term Elobixibat for Chronic Constipation

Long-term Efficacy and Safety of Elobixibat for Chronic Constipation: a Multicenter, Randomised, Double-blind, Placebo-controlled Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Yokohama City University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

In this double-blind comparative study, AJG533 (elobixibat) 10 mg or AJG533 placebo was orally administered once daily before meals for 12 weeks in patients with chronic constipation, and the primary endpoint was the change from Week 2 of the observation period in the number of complete spontaneous bowel movements (CSBM) at Week 12 of the treatment period. The primary endpoint was the change in the number of complete spontaneous bowel movements (CSBM) from Week 2 of the observation period.

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
DRUG	Elobixibat 10mg	Patients with chronic constipation are administered Elobixibat 10mg for 12 weeks
DRUG	Placebo	Patients with chronic constipation are administered placebo for 12 weeks

Timeline

• Start date: 2021-08-06
• Primary completion: 2023-06-30
• Completion: 2023-11-30
• First posted: 2021-03-05
• Last updated: 2023-01-05

Locations

1 site across 1 country: Japan