Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutica
• Treatments: Hydromorphone

Criteria

Inclusion Criteria:

• Participant with histological confirmed malignancy

• Participant on stable morphine or 25 milligram oxycodone dose equivalent per day. Stable dose is defined as no dose change for 3 consecutive days and does not require more than 3 doses of rescue medication per day

• Life expectancy of at least 3 months

• Negative urine pregnancy test

• Participants with signed informed consent

Exclusion Criteria:

• Participant intolerant or hypersensitive to hydromorphone or other opioid agonist

• Participant with unstable medical condition

• Participant with renal dysfunction and liver dysfunction

• Participant dependence to opiates

• Inability to take oral medication