Study to compare Oxycodone/Naloxone to Codeine/Paracetamol in the Treatment of Knee and/or hip Pain Due to Osteoarthritis

Active, not recruiting

• Conditions: Moderate to Severe Chronic Knee and/or hip Pain Due to Osteoarthritis; MedDRA version: 14.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; MedDRA version: 14.1Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-004796-39-IT
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-23
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female subjects older than 60 years old.
• Subjects with a clinical diagnosis of degenerative or primary OA with moderate to severe chronic pain (NRS>4) that require around-the-clock opioid therapy. Subjects will identify the most painful joint (hip or knee) for documentation of OA. Pain measurement will be done at this joint only.
• Subjects willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
• Subjects in which the pre-study, non-opioid analgesics, and all other concomitant medications, including those medications for the treatment of depression are anticipated to remain stable throughout the treatment phase of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 82
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

• Any history of hypersensitivity to oxycodone, naloxone, codeine, ibuprofen, or related products and ingredients.
• Any contraindication to oxycodone, naloxone, codeine, paracetamol or ibuprofen.
• Subjects with evidence of significant structural abnormalities of the GI tract (e.g., bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g., ileus, hypothyroidism).
• Subjects with cancer associated pain.
• Subjects with secondary osteoarthritis (e.g. fracture, septic, acromegaly etc.).
• Active alcohol or drug abuse and/or history of opioid abuse.
• Subjects with Rheumatoid Arthritis.
• Subjects with evidence of clinically unstable disease
• Subjects with active or history of epilepsy
• Subjects receiving hypnotics or other CNS depressants that, in the in Ivestigator's opinion, may pose a risk of additional CNS depression with opioid study medication
• Subjects with evidence of impaired liver/kidney function upon entry into the study defined as: Aspartate aminotransferase, alanine aminotransferase (AST, ALT) levels >3 times the upper limit of normal; Gamma glutamyl transpeptidase (GGT) =5 times the upper limit of normal; Total bilirubin level outside of the reference range (unless the value is associated with pre documented Gilbert's Syndrome); cholinesterase <2000 UI; INR>2; Creatinine clearance < 40 ml/min.
• Subjects with a history of depression or other psychiatric disorder that in the opinion of the investigator is significant enough to exclude the subject from the study.
• Mental impaired patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the differences in terms of efficacy and tolerability between two pharmacological protocols in patients with chronic pain from osteoarthritis;Secondary Objective: - Evaluation of the differences, between the two pharmacological protocols, in terms of quality of life, by means of the SF-12.<br><br>- Evaluation of the differences, between the two pharmacological protocols, in scores obtained in the WOMAC physical function and stiffness subscales.<br>;Primary end point(s): Evaluate the differences in terms of efficacy and tolerability between two pharmacological protocols in patients with chronic pain from osteoarthritis.;Timepoint(s) of evaluation of this end point: 15 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluation of the differences, between the two pharmacological protocols, in terms of quality of life, by means of the SF-12.<br><br>Evaluation of the differences, between the two pharmacological protocols, in scores obtained in the WOMAC physical function and stiffness subscales.<br>;Timepoint(s) of evaluation of this end point: 30 and 90 days