Evaluation of NaproxenSodium and CodeinePhosphate Combination in Osteoarthritis

Istanbul Medeniyet University

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis

Treatments

Drug: Placebo

Drug: Naproxen Sodium Codeine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02501564

NAPCOD2013

Details and patient eligibility

About

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.

Full 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.

Enrollment

135 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical and radiological diagnosis of primary osteoarthritis (knee and hip) in the recent year according to criteria of American College of Rheumatology (ACR)
Grade 1, 2 or 3 osteoarthritis patients
Patients 40 to 65 years of age
Patients with WOMAC score ≥ 40
Patients with VAS score ≥ 40
Patients who signed the consent form

Exclusion criteria

Grade 4 osteoarthritis patients / Pregnant or breastfeeding mothers
Patients with known allergic reaction or intolerance to NSAIDs (nonsteroidal antiinflammatory drugs)
Patients hypersensitive to naproxen sodium or codeine
Patients who took another analgesic medicine during 24 hours before and/or a nonsteroidal anti-inflammatory medicine during 72 hours before taking study medicine
Patients with active gastric or duodenum ulcer
Patients with renal dysfunction and/or a kidney disease
Patients with severe liver disease
Patients with rare hereditary galactose intolerance, Lapp lactase insufficiency or glucose-galactose malabsorption problem
Patients with depression treated by a medicine from monoamine oxidase class
Patients with uncontrolled hypertension or patients with hypertension that is hardly controlled with medicines
Patients with a known medical, psychological disturbance or social status that may negatively affect inclusion into the study or patients who may lead to increase in risk for others with inclusion into the study
Patients with proven clinically important and unstable systemic medical disease
Patients who have medical contraindication for study medicine
Patients who are judged by investigator that they will not adhere or adequately adhere to the study protocol
Patients who participated into another study with another study medicine in the last 4 week
Patients who intent to donate blood or blood product during the study period or in the following month of the study completion