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

NCT02355236 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2015-03-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Severance Hospital

    lead OTHER

Principal Investigators

  • Seong-Hwan Moon, M.D., Ph.D. · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02355236 on ClinicalTrials.gov