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. 2014 Sep 17;2014(9):CD003115. doi: 10.1002/14651858.CD003115.pub4

Markenson 2005.

Methods Randomised controlled trial
 2‐arm parallel group design
 Trial duration: 13 weeks
 Multicentre trial with 9 centres
 Power calculation reported
Participants Participants with moderate‐to‐severe pain while taking NSAIDs/paracetamol, with contraindications to NSAID therapy or with previous oral opioid therapy were eligible
 109 participants were randomised
 107 participants with osteoarthritis were reported at baseline
 Affected joints: 33 knees, 19 hips, and 57 other joints
 Number of females: 78 of 107 (73%)
 Mean age: 63 years
Interventions Experimental intervention 
 Oral oxycodone (OxyContin), 10 mg twice daily
Control intervention 
 Placebo, twice daily
Treatment duration: 13 weeks
 Analgesics other than study drugs allowed and intake assessed, but it was unclear whether intake was similar
Outcomes Extracted pain outcome: global pain after 13 weeks
 Extracted function outcome: WOMAC global scale after 13 weeks
Notes Sponsor: Purdue Pharma
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The computer‐generated randomization code and study drug bottles labeled with randomization numbers were supplied by the sponsor"
Allocation concealment (selection bias) Low risk Quote: "The computer‐generated randomization code and study drug bottles labeled with randomization numbers were supplied by the sponsor"
Described as double‐blind? Low risk Quote: "This was a double blind, randomized, placebo‐controlled, parallel‐group study"
Blinding of patients? Low risk Because the study used indistinguishable interventions, we considered participants to be blinded
Quote: "Patients who met the entry criteria were randomly assigned in double blind fashion to receive either 10‐mg tablets of CR oxycodone or matching placebo every 12 hours"
Blinding of physicians? Low risk Because coded labelled bottles were provided by sponsor and drug tables were matching the placebo tablets, physicians were considered blinded as well
Blinding of outcome assessors? Low risk Because participants were blinded and outcomes were participant‐reported, the risk of detection bias was considered low
Interventions reported as indistinguishable? Low risk Quote: "Patients who met the entry criteria were randomly assigned in double blind fashion to receive either 10‐mg tablets of CR [controlled release] oxycodone or matching placebo every 12 hours"
Double‐dummy technique used? High risk No double‐dummy technique used
Intention‐to‐treat analysis performed? 
 Pain High risk 2 randomised participants who withdrew before receiving treatment were excluded from the analyses
Intention‐to‐treat analysis performed? 
 Function High risk 2 randomised participants who withdrew before receiving treatment were excluded from the analyses