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

PHASE4TerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Pain
Interventions
DRUG

Osmotic Release Oral System (OROS) hydromorphone

OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutica

INDUSTRY