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Sponsored by: |
Napp Pharmaceuticals Limited |
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Information provided by: | Napp Pharmaceuticals Limited |
ClinicalTrials.gov Identifier: | NCT00784810 |
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 |
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Osteoarthritis Back Pain |
Drug: Oxycodone/Naloxone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Double-Dummy, Parallel Group, Randomised Study to Compare the Efficacy and Tolerability of Oxycodone/Naloxone Prolonged Release (OXN PR)
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Estimated Enrollment: | 244 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Oxycodone/Naloxone
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Drug: Oxycodone/Naloxone
Treatment of moderate to severe chronic low back pain or pain due to osteoarthritis
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2: Active Comparator
Codeine/Paracetamol
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Drug: Oxycodone/Naloxone
Treatment of moderate to severe chronic low back pain or pain due to osteoarthritis
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jill Kiteley | info@contact-clinical-trials.com | |
Contact: Margaret Wilson | info@contact-clinical-trials.com |
Study ID Numbers: | 2008-002426-10 |
Study First Received: | November 3, 2008 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00784810 History of Changes |
Health Authority: | United Kingdom: Research Ethics Committee |
Efficacy tolerability moderate severe oxycodone naloxone codeine |
paracetamol chronic low back pain osteoarthritis Moderate to severe chronic low back pain or pain due to osteoarthritis. |
Osteoarthritis Joint Diseases Narcotic Antagonists Oxycodone Central Nervous System Depressants Low Back Pain Narcotics Pain Rheumatic Diseases Back Pain Codeine Naloxone |
Naphazoline Signs and Symptoms Musculoskeletal Diseases Guaifenesin Analgesics, Non-Narcotic Arthritis Neurologic Manifestations Phenylpropanolamine Peripheral Nervous System Agents Analgesics Analgesics, Opioid Acetaminophen |
Respiratory System Agents Osteoarthritis Narcotic Antagonists Oxycodone Physiological Effects of Drugs Pain Naloxone Signs and Symptoms Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Analgesics Acetaminophen Analgesics, Opioid |
Joint Diseases Nervous System Diseases Low Back Pain Central Nervous System Depressants Narcotics Rheumatic Diseases Back Pain Codeine Pharmacologic Actions Analgesics, Non-Narcotic Neurologic Manifestations Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents |