NCT02501564

Evaluation of NaproxenSodium and CodeinePhosphate Combination in Osteoarthritis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Istanbul Medeniyet University · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Naproxen Sodium Codeine	One tablet twice a day
DRUG	Placebo	One tablet twice a day

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-11-01
• Completion: 2015-11-01
• First posted: 2015-07-17
• Last updated: 2016-02-25