Safety and Tolerability of Long-Term Administration of Dilaudid SR (Hydromorphone HCI) in Cancer Pain
Study DO-118X was a phase-3, multicenter, open-label extension study in adult patients with
cancer pain who had successfully completed Study DO-118 with dose-stable pain control taking
at least 8 mg of OROS hydromorphone (slow release) or its equivalent morphine sulfate SR
(slow release) dosage. Patients were started on the dose of OROS hydromorphone equivalent
to the opioid dose on which they had achieved dose-stable pain control in the SR (slow
release) phase of Study DO-118. Patients returned to their study clinic once a month for 1
year. Dosage adjustments to study medications and breakthrough pain medication were
permitted. OROS hydromorphone HCI (slow release) tablets in 8, 16, 32 and 64mg doses
administered orally every 24 hours
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study results indicated that long-term treatment with OROS hydromorphone can be useful in the management of persistent, moderate-to-severe chronic pain in patients with cancer
Alza Corporation Clinical Trial
Study Director
ALZA
United States: Institutional Review Board
CR013264
NCT00410787
April 2002
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