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

Mundipharma

Status and phase: Completed; Phase 3

Conditions: Chronic Osteoarthritis

Treatments: Drug: oxycodone naloxone tablet; Drug: Oxycodone naloxone prolonged release tablets (OXN); Drug: oxycodone prolonged release tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902837

OXN3503

2008-002670-36

Details and patient eligibility

About

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

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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181 participants in 2 patient groups

oxycodone Tablet

Active Comparator group

Description:

OxyCodone Prolonged release tablets

Treatment:

Drug: oxycodone prolonged release tablet

oxycodone naloxone tablet

Experimental group

Description:

Oxycodone naloxone prolonged release tablets (OXN)

Treatment:

Drug: Oxycodone naloxone prolonged release tablets (OXN)

Drug: oxycodone naloxone tablet