NCT05895877

Evaluate the Efficacy and Safety of Goofice® (Elobixibat) in Patients With Chronic Constipation

A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Goofice® in Patients With Chronic Constipation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 351 (estimated)
• Sponsor: Synmosa Biopharma Corp. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of Goofice® in patients with chronic constipation.

Detailed description

In order to enroll appropriate patients with chronic constipation, a 2-week constipation-related symptom intensity screening period will be established to investigate the number of bowel movements just prior to the study drug treatment initiation. Eligible subjects who fulfill all selection criteria for enrollment will be randomly assigned to receive Goofice® or placebo drug with 2:1 allocation ratio. The study drug will be received once daily approximately 30 minutes before breakfast in the 12-week treatment period. The starting dosing of Goofice® / placebo will be 10 mg (2 tablets) in treatment period. It is allowed to adjust the dosage among 5, 10, and 15 mg after 7 days after treatment initiation, if the dose adjusting criteria are met depending on symptoms. After treatment period, subjects will be followed up for 4 weeks to observe the effect of discontinuing treatment.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	Goofice®	Once daily before breakfast.
DRUG	Goofice® Placebo	Once daily before breakfast.

Timeline

• Start date: 2021-12-21
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2023-06-09
• Last updated: 2023-06-09

Locations

1 site across 1 country: Taiwan