OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
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ClinicalTrials.gov Identifier: NCT00902837 |
Recruitment Status :
Completed
First Posted : May 15, 2009
Last Update Posted : October 22, 2018
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Osteoarthritis | Drug: Oxycodone naloxone prolonged release tablets (OXN) Drug: oxycodone prolonged release tablet Drug: oxycodone naloxone tablet | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 181 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: oxycodone Tablet
OxyCodone Prolonged release tablets
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Drug: oxycodone prolonged release tablet |
Experimental: oxycodone naloxone tablet
Oxycodone naloxone prolonged release tablets (OXN)
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Drug: Oxycodone naloxone prolonged release tablets (OXN) Drug: oxycodone naloxone tablet |
- 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 [ Time Frame: End of 12 week study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902837

Responsible Party: | Mundipharma Research GmbH & Co KG |
ClinicalTrials.gov Identifier: | NCT00902837 |
Other Study ID Numbers: |
OXN3503 2008-002670-36 |
First Posted: | May 15, 2009 Key Record Dates |
Last Update Posted: | October 22, 2018 |
Last Verified: | October 2018 |
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 |
Osteoarthritis Constipation Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Signs and Symptoms, Digestive Oxycodone Naloxone |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |