NCT02501564

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2013

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

July 9, 2015

Last Update Submit

February 24, 2016

Conditions

Osteoarthritis

Keywords

OsteoarthritisNAPROXEN SODIUM

Outcome Measures

Primary Outcomes (2)

  • Change in Western Ontario Mac Master Questionnaire (WOMAC)

    7 days

  • Change in Visual Analog Scale (VAS)

    7 days

Secondary Outcomes (7)

  • Change in pain severity in all visits after treatment from baseline (VAS)

    7 days

  • Functional effects of combination therapy (WOMAC)

    7 days

  • Change in resting pain after treatment from baseline (WOMAC)

    7 days

  • Change in activity pain after treatment from baseline (WOMAC)

    7 days

  • Change in physical function after treatment from baseline (WOMAC)

    7 days

  • +2 more secondary outcomes

Study Arms (2)

Naproxen Sodium Codeine

EXPERIMENTAL

One tablet twice a day

Drug: Naproxen Sodium Codeine

Placebo

PLACEBO COMPARATOR

One tablet twice a day

Drug: Placebo

Interventions

Naproxen Sodium CodeineDRUG

One tablet twice a day

Also known as: Apranax Plus
Naproxen Sodium Codeine
PlaceboDRUG

One tablet twice a day

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopedics and Traumatology

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 17, 2015

Study Start

May 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2015

Last Updated

February 25, 2016

Record last verified: 2016-02