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. 2010 Jan 20;2010(1):CD006605. doi: 10.1002/14651858.CD006605.pub2

McIlwain 2005.

Methods RCT with case series open‐label continuation
Duration: 3‐week RCT plus 12 month open‐label continuation; total 12.7 months
Participants N = 491 enrolled in RCT, N = 153 enrolled in open‐label continuation
Primary condition: Osteoarthritis of hip or knee
Baseline pain score: 52.1 (SD 23)/100 VAS
Time since onset: Mean duration range among the randomized groups 9.1 to 10.3 years
Mean age: 60 (SD 10) years
Female: 62%
Previous opioid analgesics: Not reported, but to meet inclusion criteria patients must have had previous unsuccessful treatment with an opioid, NSAID, or Cox‐2 inhibitor for at least 75 of 90 days prior to enrolment
Interventions Oral extended‐release morphine
Initial dose: 40 mg/day
Titrated up to 80 mg/day. Doses divided.
Supplemental analgesia: All analgesics were discontinued in washout phase prior to randomization for RCT. For open‐label continuation, NSAIDS (50.3% of patients), other analgesics and antipyretics (44.4%), antidepressants (34.0%), and antipsychotics (30.7%) were taken.
Outcomes Discontinuation due to adverse events
Adverse events
Discontinuation due to insufficient pain relief
Notes Continuation of: Matsumoto AK, Babul N, Ahdieh, H. Oxymorphone extended‐release tablets relieve moderate to severe pain and improve physical function in osteoarthritis: Results of a randomized, double‐blind, placebo‐and active‐controlled Phase III trial. Pain Medicine 2005;6(5):357‐66.
Risk of bias
Bias Authors' judgement Support for judgement
Comparability of patients at baseline and follow‐up (continuous data) 
 All outcomes High risk Due to attrition
Selection method random or consecutive Unclear risk Not reported
Prospective Low risk Prospective
Free from confounding treatment(s) High risk Concominant drugs allowed for extension
Patient compliance monitored and reported at at least 85%? Unclear risk Not reported
Attrition and right censoring less than 15% (continuous data) 
 All outcomes High risk Greater attrition
Funding from a source without financial conflict of interest? High risk Funded by Endo Pharmaceuticals and Penwest Pharmaceuticals