Evaluation of NaproxenSodium and CodeinePhosphate Combination in Osteoarthritis

Osteoarthritis Clinical Trial

Official title: Randomized, Double-blind and Placebo-controlled Evaluation of Efficacy and Safety of Naproxen Sodium and Codeine Phosphate Combination in Osteoarthritis

Status Completed

Clinical Trial Summary

Osteoarthritis (OA) pain treatment has limitations in terms of serious adverse effects and low efficacy. The investigators aimed to evaluate efficacy and safety of naproxen sodium/codeine phosphate combination in these patients.

Clinical Trial Description

In this prospective, randomized, double blind, placebo controlled clinical trial, 135 patients with osteoarthritis, who were 40-65 years; applied to institution's orthopaedics outpatient clinic; had grade 1, 2, or 3 primary osteoarthritis diagnosed in last 1 year; and had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score≥40, and Visual Analogue Scale score≥40,were enrolled. Subjects were randomized (1:1) to placebo (n= 67) or combination (n= 68) arms, in which 550 mg naproxen sodium/30mg codeine phosphate was given orally twice a day for 7 days. Rescue medicine was 500 mg paracetamol (max= 6 tablets/day). Demographic characteristics, medical history, adverse events, VAS and WOMAC scores were collected in study visits performed within 10days.The study was approved by local institutional ethics committee and written informed consents were obtained from all participants. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

• NCT number: NCT02501564
• Study type: Interventional
• Source: Istanbul Medeniyet University
• Status: Completed
• Phase: Phase 4
• Start date: May 2013
• Completion date: November 2015