NCT01051388

Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation

Prophylactic Efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients Continuously Treated With Low-dose Aspirin-Randomized, Multi-center, Single-blinded, Parallel-group, Comparative Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection.

Detailed description

The events of recurrence of gastric and/or duodenal ulcers will be evaluated due to a blinded manner by specialized endoscopists at pre- and post administration during 12 weeks administration of PPI (Rabeprazole sodium 10 mg or 20 mg tablet once a day) or the mucosal defensive drug (Gefarnate 50mg Capsule twice a day).

Conditions

• Cardio-cerebrovascular Disease

Interventions

Type	Name	Description
DRUG	Low-dose PPI (Rabeprazole sodium)	PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three
DRUG	High-dose PPI (Rabeprazole sodium)	PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)
DRUG	Non-PPI (Gefarnate)	The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2010-01-18
• Last updated: 2011-04-04

Locations

1 site across 1 country: Japan