Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04189705
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2019-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Multi-center, Randomized, Double-blind, Active-controlled, Non-inferiority, Phase 3 Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
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:
This is a multi-center, randomized, double-blind, active-controlled, non-inferiority, phase 3 study to evaluate the efficacy and safety of MCT-SR in patients with gastritis.
Detailed Description:
To contribute greater treatment compliance and patient convenience, the rebamipide SR formulation has been developed.
Study Oversight
Has Oversight DMC:
None
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?: