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

Constipation Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05895877
Study type Interventional
Source Synmosa Biopharma Corp.
Contact Yayoi Lai
Phone 886-2-87977100
Email yayoi1413@synmosa.com.tw
Status Recruiting
Phase Phase 3
Start date December 21, 2021
Completion date September 30, 2023
View Details
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