Status:
COMPLETED
An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release)
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Osteoarthritis, Knee
Osteoarthritis, Hip
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to characterize the effectiveness and safety of OROS hydromorphone HCL and OxyContin in patients with chronic osteoarthritis (OA) of the knee or hip who are receiving chr...
Detailed Description
This was a multicenter, open-label, randomized (patients are assigned different treatments based on chance), dose-titration, parallel-group study characterizing the effectiveness and safety of OROS hy...
Eligibility Criteria
Inclusion
- Patient who met criteria (functional Class I-III in the hip or knee) for osteoarthritis for at least 3 months before enrollment
- Patient who had moderate to severe chronic pain despite regular use and stable doses of an NSAID (nonsteroidal anti-inflammatory drug) or an NSAID with opioid analgesic taken as needed but not on a daily basis for the treatment of osteoarthritis.
Exclusion
- Patient intolerant of or hypersensitive to hydromorphone or oxycodone
- Patient of childbearing potential must use medically recognized contraceptive program before and during the study
- Pregnant or breastfeeding
- Patient who had prior joint replacement of the target knee or hip
- Patient with significant respiratory compromise or depressed ventilatory function
- Patient who was known active drug abuser or alcoholics.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2001
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00399048
End Date
May 1 2001
Last Update
April 27 2010
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