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Evaluation of NaproxenSodium and CodeinePhosphate Combination in Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02501564
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : February 25, 2016
Abdi Ibrahim Ilac San. ve Tic A.S.
Information provided by (Responsible Party):
KAYA AKAN, MD, Associate Professor, Istanbul Medeniyet University

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Naproxen Sodium Codeine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind and Placebo-controlled Evaluation of Efficacy and Safety of Naproxen Sodium and Codeine Phosphate Combination in Osteoarthritis
Study Start Date : May 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Naproxen Sodium Codeine
One tablet twice a day
Drug: Naproxen Sodium Codeine
One tablet twice a day
Other Name: Apranax Plus

Placebo Comparator: Placebo
One tablet twice a day
Drug: Placebo
One tablet twice a day

Primary Outcome Measures :
  1. Change in Western Ontario Mac Master Questionnaire (WOMAC) [ Time Frame: 7 days ]
  2. Change in Visual Analog Scale (VAS) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Change in pain severity in all visits after treatment from baseline (VAS) [ Time Frame: 7 days ]
  2. Functional effects of combination therapy (WOMAC) [ Time Frame: 7 days ]
  3. Change in resting pain after treatment from baseline (WOMAC) [ Time Frame: 7 days ]
  4. Change in activity pain after treatment from baseline (WOMAC) [ Time Frame: 7 days ]
  5. Change in physical function after treatment from baseline (WOMAC) [ Time Frame: 7 days ]
  6. Ratio of rescue medicine use (Rescue medication count) [ Time Frame: 7 days ]
  7. Collection of adverse event reports to evaluate safety of the medicine [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: KAYA AKAN, MD, Associate Professor, Associate Professor of Orthopedics and Traumatology, Istanbul Medeniyet University Identifier: NCT02501564    
Other Study ID Numbers: NAPCOD2013
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Keywords provided by KAYA AKAN, MD, Associate Professor, Istanbul Medeniyet University:
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents