Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)
Information source: Alza Corporation, DE, USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Analgesics, Opioid
Intervention: OROS hydromorphone HCI CR (Drug)
Phase: Phase 3
Sponsored by: Alza Corporation, DE, USA
Official(s) and/or principal investigator(s):
Alza Corporation Clinical Trial, Study Director, Affiliation: ALZA
The purpose of study was to characterize the safety and tolerability of long-term repeated
dosing of OROS hydromorphone controlled release tablets (8,16,32, and 64 mg) in patients
with chronic cancer pain or chronic non-malignant pain.
Official title: Safety and Tolerability of Long-term Administration of Dilaudid CR (Hydromorphone HCI)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Effectiveness of OROS hydromorphone was maintained throughout the study. OROS hydromorphone provided moderate pain relief in patients with chronic cancer/chronic non-malignant pain.
Secondary outcome: Long term administration of OROS hydromorphone was safe and well tolerated.
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Patients who have chronic cancer or chronic non-malignant pain, including pain
associated with AIDS, who have successfully completed a OROS hydromorphone HCI
(controlled release) short-term study (i. e. Study DO-104, DO-105, or DO-119)
- Patients who require at least 8 mg of hydromorphone HCI every 24 hours for the
management of chronic cancer or chronic non-malignant pain
- Patients whose opioid requirements have been stable as demonstrated in a OROS
hydromorphone HCI (controlled release) short-term study
- Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
- Patients who are pregnant or breast-feeding
- Patients with any gastrointestinal disorder, including pre-existing severe GI
narrowing (pathologic or iatrogenic) that may affect the absorption or transit of
orally administered drugs
- Patients with clinically significant impaired renal or hepatic function, Addison's
disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
- Patients with any significant CNS disorder, including but not limited to head injury,
intracranial lesion, increased intracranial pressure, seizure disorder, stroke within
the past 6 months, and disorders of cognition
- Patients who are known active drug abusers or alcoholics
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