Pain Clinical Trial
Official title:
Randomized, Open-Label, Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROS Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-malignant Pain Requiring Continuous Opioid Therapy.
The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will also determine the dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by control-released oxycodone (equi-analgesic dosage).
Conventional immediate-release forms of hydromorphone and oxycodone have a relatively short
duration of action that require dosing every 4 to 6 hours. To counterbalance the drawback of
repeated opioid intake, sustained-release formulations of oxycodone and hydromorphone were
developed that allow twice-daily dosing. Subsequently, a novel, once-daily, extended-release
hydromorphone formulation was developed to further enhance ease of treatment and improve
effectiveness in the treatment of severe pain. This is a randomized, open-label,
comparative, parallel-group, 24-week flexible-dose study in patients with chronic noncancer
pain severe enough to require continuous opioid therapy. Patients will receive either 8 mg
of sustained-release hydromorphone, taken once daily or 10 mg of controlled-release
oxycodone, taken twice daily. Individual adjustments in dosing will be performed to achieve
satisfactory pain control, up to a maximum daily dosage of 32 mg for hydromorphone and 80 mg
for oxycodone. The primary efficacy outcome will be the determination of the dose of
hydromorphone that produces a level of pain control that is equal to the pain control
provided by oxycodone (equi-analgesic dose). Safety will be monitored throughout the study.
The study hypothesis is that sustained-release hydromorphone taken once daily is well
tolerated and is not inferior with regard to pain control to controlled-release oxycodone
taken twice daily.
Amendment:
Amendment was made to the duration of the study from duration of '24 weeks' to '52 weeks' in
order to collect long-term safety and efficacy data. OROS hydromorphone 8, 16, or 32 mg
tablets QD or SR oxycodone 10, 20, or 40 mg tablets BID. Individual adjustments in dosing
performed to achieve satisfactory pain control over 24 weeks. Amendment: treatment duration
was extended to 52 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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