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

NCT04804267 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2021-03-18

No results posted yet for this study

Summary

The objective of this study is to evaluate the clinical equivalence of the test formulation of Linaclotide compared to the marketed formulation LINZESS® in patients with Chronic Idiopathic Constipation, and to evaluate the efficacy and safety of the test formulation of Linaclotide in the treatment of Chronic Idiopathic Constipation.

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

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804267 on ClinicalTrials.gov