OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects

Study Overview
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Brief Summary
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The primary objectives are to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function. to demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone

Detailed Description
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Subjects with moderate to severe pain due to osteoarthritis (OA) will be randomised to oxycodone/naloxone prolonged release (OXN PR) or oxycodone prolonged release tablets (OxyPR) alone to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function and to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation compared to subjects taking OxyPR alone.

Official Title
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Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee &/or Hip Taking Oxycodone Equivalent of 20 - 80 mg/Day as Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Subjects Taking Oxycodone Prolonged Release Tablets (OxyPR) Alone.

Conditions
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Chronic Osteoarthritis

Intervention / Treatment
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* Drug: Oxycodone naloxone prolonged release tablets (OXN)
* Drug: oxycodone prolonged release tablet
* Drug: oxycodone naloxone tablet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Moderate to severe chronic nonmalignant OA and that require around-the-clock opioid therapy. Exclusion criteria: Females who are pregnant or lactating. Subjects with evidence of significant structural abnormalities of the gastrointestinal tract. Subjects with evidence of impaired liver/kidney function upon entry into the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxycodone Tablet<br>OxyCodone Prolonged release tablets | Drug: oxycodone prolonged release tablet<br> <br> |
| Experimental: oxycodone naloxone tablet<br>Oxycodone naloxone prolonged release tablets (OXN) | Drug: Oxycodone naloxone prolonged release tablets (OXN)<br> <br> Drug: oxycodone naloxone tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that treatment with OXN PR tablets is non-inferior to treatment with OxyPR with regards to analgesic efficacy & locomotor function. To demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone prolonged re |  | End of 12 week study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomised, double-blind, double-dummy, parallel-group, non-inferiority, pain locomotor function, improvement in symptoms of constipation, moderate to severe pain due to osteoarthritis (OA), OXN PR, OxyPR, Moderate to severe chronic nonmalignant OA