An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release)

• Status: Completed
• Trial end date: 2001-05-01
• Target enrollment: 0
• Participant gender: All

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 chronic nonsteroidal anti-inflammatory drug (NSAID) or other nonsteroidal, non-opioid analgesic (ie, acetaminophen or aspirin) therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Hydromorphone; Oxycodone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.