NCT04804267View on ClinicalTrials.gov

Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation

PHASE3UnknownINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

March 5, 2021

Primary Completion Date

August 31, 2022

Study Completion Date

August 31, 2022

Conditions
Chronic Idiopathic Constipation
Interventions
DRUG

Linaclotide

Manufactured by Jiangsu Hansoh Pharmaceutical Co., Ltd. Drug: Linaclotide 145μg orally once daily

DRUG

LINZESS®

Manufactured by Almac Pharma Services Limited Drug: Linaclotide 145μg orally once daily

DRUG

Placebo

Drug: Placebo orally once daily

Trial Locations (1)

200127

RECRUITING

Renji Hospital, Medical Collge of Shanghai Jiaotong University, Shanghai

Sponsors
All Listed Sponsors
lead

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

NCT04804267 - Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation | Biotech Hunter | Biotech Hunter