NCT01150162

Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Otsuka Pakistan Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Ulcer

Interventions

Type	Name	Description
DRUG	Rebamipide and Omeprazole	open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks
DRUG	Omeprazole	open label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2010-06-24
• Last updated: 2013-02-04

Locations

3 sites across 1 country: Pakistan