Who is sponsoring NCT00641004?

NCT00641004 is sponsored by Otsuka Pharmaceutical, Inc., Philippines.

What condition does NCT00641004 study?

NCT00641004 studies NSAID Induced Gastropathy.

What drugs are being tested in NCT00641004?

Interventions: Rebamipide and Esomeprazole.

What is the status of NCT00641004?

NCT00641004 is currently COMPLETED.

Last reviewed 2011-08-23 · How we verify

Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-induced Gastropathy

NCT00641004 Phase 4 COMPLETED

Primary objective: To determine the levels of malondialdehyde (MDA) and immunohistochemistry surrogate of inflammation in patients with NSAID-induced gastric mucosal injury treated with Rebamipide 3x a day vs Esomeprazole 40mg once a day. Secondary objective: For patients who become symptomatic during NSAID treatment, to compare the proportion of patients with positive treatment effects using the Likert scale. Third objective: To compare the proportion of patients with positive treatment effects as determined by Modified Lanza scoring between the two groups.

Details

Lead sponsor	Otsuka Pharmaceutical, Inc., Philippines
Phase	Phase 4
Status	COMPLETED
Enrolment	30
Start date	2008-04
Completion	2010-03

Conditions

NSAID Induced Gastropathy

Interventions

Rebamipide and Esomeprazole

Primary outcomes

To determine the levels of MDA and immunohistochemistry surrogate of inflammation in patients with NSAID-induced gastric mucosal injury. — Throughout the study

Countries

Philippines