NCT02355236

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

A Prospective, Randomized, Double-blinded, Double-dummy, Active-controlled, Multi-center, Interventional Study to Compare Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Severance Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 10 orthopedic investigators will participate in this study. The effectiveness in gastro-protection of study drug will be assessed by Leeds Dyspepsia Questionnaire (LDQ). The orthopedic investigators will be trained with this questionnaire administration by an expert gastroenterologist prior to starting this study.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Naproxen/Esomeprazol 500/20mg	Tablet, b.i.d.
DRUG	Celecoxib 200mg	Capsule, o.d.
DRUG	Naxozol-Placebo	Tablet (which is identical to Naxozol), b.i.d.
DRUG	Comparator-Placebo	Capsule (which is identical to Celebrex), o.d.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-02-04
• Last updated: 2015-03-23

Locations

10 sites across 1 country: South Korea