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

Study on the Effectiveness and Safety of OROS Hydromorphone in Pain Management Among Patients With Cancer Pain

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.

This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The duration of this study will be 28 days and will include visits at: Day 0 (Baseline), Day 7, 14 and 28. The OROS hydromorphone will be administered orally for 28 days and dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. Rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Brief Pain Inventory score. Participants' safety will be monitored throughout the study.

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