Status:
COMPLETED
Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Pain
Analgesics, Opioid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2000
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT00410748
End Date
June 1 2000
Last Update
April 27 2010
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