Evidence Table 1Update 6: Data abstraction of head-to-head trials

Author Year
Trial name (Quality rating-optional)
PopulationInterventionsAllowed other medications/interventionsAge
Other population characteristicsNNumber withdrawn/lost to follow-up/analyzedEfficacy/effectiveness outcomesHarmsTotal withdrawals; withdrawals due to adverse eventsFundingComments
Hale, 2007

Adults meeting ACR criteria for OA of the knee or hip for ≥3 months before enrolment with a mean daily pain rating at the affected joint of moderate to severe, despite chronic se of stable doses (at least 30 days with no regimen change) of NSAIDs or other non steroidal, non opioid therapies.
  1. OROS hydromorphone QD max dose 64 mg
  2. ER oxycodone BID max dose 80/80mg
    for 6 weeks (parallel)
ASA: 21%
Tramadol: 11.3%
Propoxyphene/acetaminophen: 7.3%
Hydrocodone/acetaminophen: 4.0%
Age: 63.6 years
Female: 69.4%
White 85.5%
Black: 4.8%
Other: 5.6%
Mean weight: 91.2kg
Affected joint
Knee: 79.8%
Hip: 20.2%
Mean Pain intensity at screening: 2.5
14055/1/124OROS Hydromorphone vs ER oxycodone
Mean change from baseline in pain relief: 0.8 vs 0.75; 95% CI, −0.35 to ∞
Mean change in pain intensity score: −6.0 vs −4.0; 95% CI, −0.53 to ∞
Time to third day of moderate to complete pain relief, mean (SD) days: 6.2 (4.00) vs 5.5 (2.57); 95% CI, −0.31 to ∞
Mean (SD) change (improvement) from baseline in patient global evaluation: 1.2 (1.01) vs 1.0 (1.33), P=NS between groups
Proportion of patients rated treatment effectiveness as good, very good and excellent: 67.2% vs 66.7%
Mean (SD) improvement in investigator global evaluation: 1.2 (1.01) vs 1.1 (1.16)
Proportion of investigators rated treatment effectiveness as good, very good and excellent: 71.9% vs 70.0%
Mean (SD) change in WOMAC total score from baseline: −2.0 (1.90) vs −1.8 (2.14)
Mean (SD) change in WOMAC pain subscale score from baseline: −2.1 (1.96) vs −2.0 (2.03)
Mean (SD) change in WOMAC stiffness score from baseline: −2.2 (2.37) vs −2.2 (2.72)
Mean (SD) change in WOMAC physical function subscale score: −1.9 (1.99) vs −1.7 (2.1)
Sleep disruption and daytime somnolence: 25.7 (17.82) vs 35.3 (22.56), P<0.012
Change from baseline on MOS sleep problems index I: −13.3 (21.10) vs −5.2 (22.09), P<0.045
Change from baseline on MOS sleep problem index II: −13.0 vs −7.0, P=NS (data interpreted from graph)
OROS Hydromorphone vs ER oxycodone
Proportion of patients with any AE: 78.9% vs 79.1%, P=NS
Proportion of patients with SAE: 4.2% vs 1.5%
Nausea: 35.2% vs 29.9%
Constipation: 29.6% vs 25.4%
Somnolence: 25.4% vs 17.9%
Vomiting: 16.9% vs 11.9%
Dizziness (excluding vertigo): 14.1% vs 22.4%
Headache: 5.6% vs 10.4%
OROS Hydromorphone vs ER oxycodone
Total withdrawals: 39.4% vs 39.1%
Withdrawals due to AE: 35.2% vs 32.8%
Study protocol developed by Knoll Pharmaceutical Company, NJ. Conduct of the study supported by Alza Corporation, CA. Assistance in preparing the first draft of the manuscript by Pharma Genesis Inc., PA
Non-inferiority study
Katz, 2010 (J Pain) U.S.

Adult patients with chronic pain due to OA of the knee or hip as designated by ACR criteria requiring treatment of the affected joint with non opioid analgesics or had received opioid therapy equivalent to ≤40mg/d of oral morphine
  1. ERMS max dose 20–160mg BID
  2. ALO-01 20–80mg
    for 14 days (Crossover)
Acetaminophen used as rescue medication.
Proportion of rescue medication used, ERMS vs ALO-01: 57.7% vs 50.7%
Median age: 57.0 (range 28 to 83 years)
Female: 68.5%
White: 88.3%
Mean weight: 90.2kg
Mean BMI: 32.4kg/m2
Location of OA pain
Right knee: 11.7%
Left hip: 4.5%
Right hip: 11.7%
723/0/72ERMS vs ALO-01
Mean in-clinic pain intensity score change from baseline: 0.3 vs 0.2 (data from graph), P=NS
Mean daily pain score summed over 14 days (Data from graph):
 Worst: 43 vs 42.5, Least: 20 vs 19.5, Average: 29.5 vs 29, Current: 28 vs 27.5, p=NS
No significant difference between ERMS and ALO-01 in change from baseline in WOMAC pain, physical function and composite index subscales.
WOMAC stiffness score at day 14: 12.3 vs 2.5, P=0.02
Proportion of patients rating treatment good, very good or excellent: 78.9% vs 91.5%
ERMS vs ALO-01
Constipation: 12.7% vs 15.5%
Nausea and somnolence: 8.5% vs 9.9%
Vomiting: 4.2% vs 8.5%
Dizziness: 7.0% vs 1.4%
Headache: 8.5% vs 4.2%
Dry mouth: 1.4% vs 0.0%
Pruritus: 1.4% vs 1.4%
Fatigue: 0.0% vs 2.8%
Pruritus generalized: 2.8% vs 0.0%
Muscle spasms: 4.2% vs 4.2%
ERMS vs ALO-01
Total withdrawals: 2.8% vs 2.7%
Withdrawals due to AE: 2.8% vs 2.7%
King Pharmaceuticals

From: Evidence Tables

Cover of Drug Class Review: Long-Acting Opioid Analgesics
Drug Class Review: Long-Acting Opioid Analgesics: Final Update 6 Report [Internet].
Carson S, Thakurta S, Low A, et al.
Portland (OR): Oregon Health & Science University; 2011 Jul.
Copyright © 2011 by Oregon Health & Science University.

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