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 |
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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 |