Trial Information

Safety and Tolerability of Long-term Administration of Dilaudid CR (Hydromorphone HCI)

This was a Phase 3, multicenter, open-label, extension study to characterize the safety and
tolerability of long-term, repeated dosing of OROS hydromorphone in patients with chronic
cancer or chronic non-malignant pain. Patients with chronic cancer or chronic non-malignant
pain had completed an OROS hydromorphone short-term study (DO-104, DO-105, DO-119) of
approximately 4 weeks duration. During this study, patients continued to receive the dose
of OROS hydromorphone that they had been receiving in the short-term study, with dose
adjustments as needed to control pain and adverse events. Patients were treated on an
outpatient basis. The study was extended from 1 year to up to 2 years in duration. Monthly
evaluations of patients treated with OROS hydromorphone for chronic pain were performed to
identify adverse events, construct a safety and tolerability profile, and assess efficacy.
Dose adjustments were permitted to provide for disease progression, pain control, and
adverse events. Quarterly physical examinations were performed to detect significant
changes in the underlying condition of patients or changes that may have been associated
with long-term opioid therapy. OROS hydromorphone 24 hour controlled release tablets in 8,
16, 32 and 64 mg were ingested orally daily up to 1 year with dose adjustments as needed to
control pain and adverse events.