Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pakistan Limited
• Treatments: Omeprazole; Rebamipide

Criteria

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