A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis

Otsuka

Status and phase: Completed; Phase 3

Conditions: Chronic Gastritis; Acute Gastritis

Treatments: Drug: MCT-SR; Drug: Mucosta Tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04189705

037-402-00039

Details and patient eligibility

About

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.

Full description

To contribute greater treatment compliance and patient convenience, the rebamipide SR formulation has been developed.

Enrollment: 392 patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males and females aged ≥19 and <75 years
• Patients diagnosed with acute or chronic gastritis by gastroscopy with at least 1 erosion confirmed by gastroscopy within 7 days prior to the first dose of the Investigational Product(IP)

Exclusion criteria

• Patients ineligible for gastroscopy
• Patients who took other drugs for treating gastritis within 2 weeks prior to the first dose of the IP.
• Patients who have to continue taking drugs that may induce gastritis
• Other clinically significant medical or psychiatric findings that the investigator considers inappropriate for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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392 participants in 2 patient groups

MCT-SR

Experimental group

Description:

Drug: MCT-SR 2 times/day for 2 weeks

Treatment:

Drug: Mucosta Tab.

Drug: MCT-SR

Mucosta Tab.

Active Comparator group

Description:

Drug: Mucosta Tab. 3 times/day for 2 weeks

Treatment:

Drug: Mucosta Tab.

Drug: MCT-SR