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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501564
• Other study ID #: NAPCOD2013
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2015
• Last updated: February 24, 2016
• Start date: May 2013
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

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

Intervention

Drug:
• Naproxen Sodium Codeine
One tablet twice a day
• Placebo
One tablet twice a day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Medeniyet University	Abdi Ibrahim Ilac San. ve Tic A.S.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Western Ontario Mac Master Questionnaire (WOMAC)		7 days	No
Primary	Change in Visual Analog Scale (VAS)		7 days	No
Secondary	Change in pain severity in all visits after treatment from baseline (VAS)		7 days	No
Secondary	Functional effects of combination therapy (WOMAC)		7 days	No
Secondary	Change in resting pain after treatment from baseline (WOMAC)		7 days	No
Secondary	Change in activity pain after treatment from baseline (WOMAC)		7 days	No
Secondary	Change in physical function after treatment from baseline (WOMAC)		7 days	No
Secondary	Ratio of rescue medicine use (Rescue medication count)		7 days	No
Secondary	Collection of adverse event reports to evaluate safety of the medicine		7 days	No