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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

This study has been completed.
Information provided by (Responsible Party):
Napp Pharmaceuticals Limited Identifier:
First received: November 3, 2008
Last updated: September 22, 2011
Last verified: September 2011
Results First Received: July 14, 2011  
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
Conditions: Osteoarthritis
Back Pain
Interventions: Drug: Oxycodone/Naloxone
Drug: Codeine/Paracetamol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited in primary and secondary care in the UK from 6 Feb 2009 to 24 Mar 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3-7 day screening, following 7-14 day run-in and a 12 week double-blind treatment period.

Reporting Groups
Oxycodone/Naloxone Tablets (OXN) Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
Codeine/Paracetamol Tablets Codeine/Paracetamol 15/500 and 30/500 mg

Participant Flow:   Overall Study
    Oxycodone/Naloxone Tablets (OXN)     Codeine/Paracetamol Tablets  
STARTED     124     123  
COMPLETED     61     74  
NOT COMPLETED     63     49  
Adverse Event                 32                 20  
Lack of Efficacy                 14                 11  
Withdrawal by Subject                 11                 9  
Administrative                 5                 8  
Lost to Follow-up                 1                 1  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Oxycodone/Naloxone Tablets (OXN) Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
Codeine/Paracetamol Tablets Codeine/Paracetamol 15/500 and 30/500 mg
Total Total of all reporting groups

Baseline Measures
    Oxycodone/Naloxone Tablets (OXN)     Codeine/Paracetamol Tablets     Total  
Number of Participants  
[units: participants]
  124     123     247  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     66     70     136  
>=65 years     58     53     111  
[units: years]
Mean (Standard Deviation)
  64.3  (10.53)     63.9  (10.97)     64.1  (10.73)  
[units: participants]
Female     77     81     158  
Male     47     42     89  
Region of Enrollment  
[units: participants]
United Kingdom     124     123     247  

  Outcome Measures
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1.  Primary:   Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)   [ Time Frame: Average daily pain over last 24 hours (at Week 12) ]

2.  Secondary:   Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.   [ Time Frame: Between visit 8 and 9 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Director of Medical Affairs
Organization: Napp Pharmaceuticals Ltd
phone: 01223 424444

Responsible Party: Napp Pharmaceuticals Limited 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