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| Sponsor: | Napp Pharmaceuticals Limited |
|---|---|
| Information provided by (Responsible Party): | Napp Pharmaceuticals Limited |
| ClinicalTrials.gov Identifier: | NCT00784810 |
Purpose
The purpose of this study is to compare oxycodone/naloxone combination tablet and codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or pain due to osteoarthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Back Pain |
Drug: Oxycodone/Naloxone Drug: Codeine/Paracetamol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 247 |
| Study Start Date: | February 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Oxycodone/Naloxone Tablets
Oxycodone/Naloxone combination
|
Drug: Oxycodone/Naloxone
5/2.5, 10/5 and 20/10 mg oxycodone/naloxone combination, 12 hourly
|
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Active Comparator: Codeine/Paracetamol Tablets
Codeine/Paracetamol combination
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Drug: Codeine/Paracetamol
15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Napp Pharmaceuticals Limited |
| ClinicalTrials.gov Identifier: | NCT00784810 History of Changes |
| Other Study ID Numbers: | OXN4502 (2008-002426-10) |
| Study First Received: | November 3, 2008 |
| Results First Received: | July 14, 2011 |
| Last Updated: | September 22, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
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Efficacy, tolerability, moderate/severe, oxycodone/naloxone codeine/paracetamol, chronic low back pain, osteoarthritis |
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Back Pain Low Back Pain Osteoarthritis Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Acetaminophen Codeine Oxycodone Naloxone |
Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics Narcotic Antagonists |