Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation (MGES)

Otsuka

Status and phase: Completed; Phase 3

Conditions: Gastric Ulcer

Treatments: Drug: Rebamipide and Omeprazole; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01150162

037-POA-0901i

Details and patient eligibility

About

A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.

Enrollment: 129 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with dyspepsia or epigastric pain and endoscopically proven gastric and duodenal ulcers
• Required laboratory parameters and time limits (screening blood tests will be taken including hemoglobin, white blood cell count, random glucose, potassium, sodium, chlorine, creatinine, AST, ALT, bilirubin, and alkaline phosphatase)
• Age > 18 years
• A statement that all patients must have signed an informed consent form prior to registration in study

Exclusion criteria

• Patients who had undergone surgery for ulcers
• History of hypersensitivity to drugs to be used in the study
• Women who are pregnant or lactating or intended to get pregnant during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

Mucosta and Omeprazole

Experimental group

Treatment:

Drug: Rebamipide and Omeprazole

Omeperazole

Active Comparator group

Treatment:

Drug: Omeprazole