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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902837

Enrollment

181

Registered

2009-05-15

Start date

2009-05-31

Completion date

2010-07-31

Last updated

2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Osteoarthritis

Keywords

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

Brief summary

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

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.

Interventions

DRUGOxycodone naloxone prolonged release tablets (OXN)

DRUGoxycodone prolonged release tablet

DRUGoxycodone naloxone tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

Belgium, Czechia, Finland, Germany, Hungary, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026