A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis
A Double-blind, Double-dummy, Parallel Group, Randomised Study to Compare the Efficacy & Tolerability of Oxycodone/Naloxone Prolonged Release (OXN PR) & Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis
Sponsor: Napp Pharmaceuticals Limited
A PHASE4 clinical study on Back Pain and Osteoarthritis, this trial is completed. The trial is conducted by Napp Pharmaceuticals Limited and has accumulated 5 data snapshots since 2009. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)This is a randomised, double-blind, double-dummy, parallel group, 12-week study to assess the efficacy and tolerability of oxycodone/naloxone compared to codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or moderate to severe pain due to OA of the hip and /or knee.
The screening period will be 3 - 7 days duration. If a subject meets all the screening criteria they may enter the Run-in Period.
During the screening period subjects will continue to take their pre-study pain medication.
The run-in period will be 7 - 14 days duration. During the run-in period subjects will continue to take their pre-study pain medication.
Visit 3 will occur at the end of the Run-in Period (7-14 days after Visit 2). To qualify for entry into the treatment period of the study, subjects must have uncontrolled pain as shown by average daily pain scores of \>5 on 4 of the last 7 days of the run in period.
Eligible subjects will be randomised to either oxycodone/naloxone or codeine/paracetamol tablets. Subjects will receive double-blind study medication for up to 12 weeks.
This is a randomised, double-blind, double-dummy, parallel group, 12-week study to assess the efficacy and tolerability of oxycodone/naloxone compared to codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or moderate to severe pain due to OA of the hip and /or knee.
The screening period will be 3 - 7 days duration. If a subject meets all the screening criteria they may enter the Run-in Period.
During the screening period subjects will continue to take their pre-study pain medication.
The run-in period will be 7 - 14 days duration. During the run-in period subjects will continue to take their pre-study pain medication.
Visit 3 will occur at the end of the Run-in Period (7-14 days after Visit 2). To qualify for entry into the treatment period of the study, subjects must have uncontrolled pain as shown by average daily pain scores of \>5 on 4 of the last 7 days of the run in period.
Eligible subjects will be randomised to either oxycodone/naloxone or codeine/paracetamol tablets. Subjects will receive double-blind study medication for up to 12 weeks.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE4
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE4
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE4
First recorded
Feb 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Napp Pharmaceuticals Limited
For direct contact, visit the study record on ClinicalTrials.gov .