McIlwain 2005.
Methods | RCT with case series open‐label continuation Duration: 3‐week RCT plus 12 month open‐label continuation; total 12.7 months |
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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 |
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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. |
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Outcomes | Discontinuation due to adverse events Adverse events Discontinuation due to insufficient pain relief |
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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 |