drugset / Trial / NCT02355236

Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis

NCT02355236

Phase 4 Unknown 106 enrolled Severance Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Naxozol is a combination product of naproxen, a non-steroidal anti-inflammatory drug (NSAID) and esomeprazole, a proton pump inhibitor which is designed to improve symptoms and reduce risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The purpose of this study is to investigate whether naxozol protects the gastrointestinal tract effectively compared to celecoxib, a COX-2 inhibitor.

Timeline

Start
2015-02
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 20 mg
Comparator Celecoxib Other / unclassified 200 mg
Subject Naproxen Small molecule 500 mg

Indications