Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT04804267
Status:
UNKNOWN
Last Update Posted:
2021-03-18
First Post:
2021-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation
Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Clinical Equivalence of Two Linaclotide Products and the Efficacy and Safety of the Test Formulation of Linaclotide in the Treatment of Chronic Idiopathic Constipation
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This is a randomized, double-blinded, placebo-controlled, multicenter study to evaluate the clinical equivalence of the test formulation of Linaclotide (manufactured by Jiangsu Hansoh Pharmaceutical Co., Ltd.) compared to the marketed formulation LINZESS® in patients with Chronic Idiopathic Constipation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: