Evaluation of NaproxenSodium and CodeinePhosphate Combination in Osteoarthritis

A Phase 4 study testing Naproxen Sodium Codeine in people with Osteoarthritis, run by Istanbul Medeniyet University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 40 to 65 years
Conditions the study is for: Osteoarthritis
What is being tested?: Naproxen Sodium Codeine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 135 participants
Where: No sites listed yet
Study dates: May 2013to Nov 2015
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

About this study

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

Read the 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
Being tested: Naproxen Sodium Codeine, Placebo
Keywords: Osteoarthritis, NAPROXEN SODIUM
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Naproxen Sodium CodeineDrug
Also called Apranax Plus
One tablet twice a day
PlaceboDrug
One tablet twice a day

Study groups in NCT02501564
Study group	Role	What they receive
Naproxen Sodium Codeine	Experimental	One tablet twice a day Receives: Drug: Naproxen Sodium Codeine
Placebo	Placebo comparator	One tablet twice a day Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Western Ontario Mac Master Questionnaire (WOMAC)
Measured: 7 days
Change in Visual Analog Scale (VAS)
Measured: 7 days

Secondary outcomes (7)

Change in pain severity in all visits after treatment from baseline (VAS)
Measured: 7 days
Functional effects of combination therapy (WOMAC)
Measured: 7 days
Change in resting pain after treatment from baseline (WOMAC)
Measured: 7 days
Change in activity pain after treatment from baseline (WOMAC)
Measured: 7 days
Change in physical function after treatment from baseline (WOMAC)
Measured: 7 days
Ratio of rescue medicine use (Rescue medication count)
Measured: 7 days
Collection of adverse event reports to evaluate safety of the medicine
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Nov 2015

First posted17 Jul 2015 (estimated)
Study startMay 2013
Primary completionNov 2014
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02501564
Sponsor's protocol ID: NAPCOD2013
Status last verified: Feb 2016
First submitted: 9 Jul 2015
Last updated: 25 Feb 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind and Placebo-controlled Evaluation of Efficacy and Safety of Naproxen Sodium and Codeine Phosphate Combination in Osteoarthritis
ClinicalTrials.gov ID: NCT02501564
Acronym / sponsor ID: NAPCOD2013
Conditions: Osteoarthritis
Keywords: Osteoarthritis, NAPROXEN SODIUM
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Istanbul Medeniyet UniversityUniversity, hospital or other
Collaborators: Abdi Ibrahim Ilac San. ve Tic A.S.
Study start: May 2013
Primary completion: Nov 2014 (actual)
Study completion: Nov 2015 (actual)
First posted: 17 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Naproxen Sodium Codeine	Experimental	Drug: Naproxen Sodium CodeineOne tablet twice a day
Placebo	Placebo comparator	Drug: PlaceboOne tablet twice a day

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Naproxen Sodium CodeineAlso: Apranax PlusOne tablet twice a day	Drug	Naproxen Sodium Codeine
PlaceboOne tablet twice a day	Drug	Placebo

Primary outcome

Change in Western Ontario Mac Master Questionnaire (WOMAC)
Time frame: 7 days
Change in Visual Analog Scale (VAS)
Time frame: 7 days

7 secondary outcomes

Change in pain severity in all visits after treatment from baseline (VAS)
Time frame: 7 days
Functional effects of combination therapy (WOMAC)
Time frame: 7 days
Change in resting pain after treatment from baseline (WOMAC)
Time frame: 7 days
Change in activity pain after treatment from baseline (WOMAC)
Time frame: 7 days
Change in physical function after treatment from baseline (WOMAC)
Time frame: 7 days
Ratio of rescue medicine use (Rescue medication count)
Time frame: 7 days
Collection of adverse event reports to evaluate safety of the medicine
Time frame: 7 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Naproxen Sodium Codeine in people with Osteoarthritis, run by Istanbul Medeniyet University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Western Ontario Mac Master Questionnaire (WOMAC) (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02501564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.