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

• Number of Patients Given Rescue Pain Medications [ Time Frame: 28 days ] [ Designated as safety issue: No ]
• Change in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
  The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of change per visit, from "very much worse" to "very much improved".
• Incidence of Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: No ]
• Incidence of discontinuation due to Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: No ]

The purpose of this study is to evaluate the effectiveness and safety of OROS hydromorphone using standardized conversion from prior opioid therapy among patients with cancer pain.

This is a prospective, open label (all people know the identity of the intervention), single-arm, multicenter study to evaluate the effectiveness and safety of a standardized conversion from prior opioid therapy to a stable dose of OROS hydromorphone among patients with cancer pain. Participants will be patients with cancer pain who are on stable dose of morphine or oxycodone. Patients will be followed-up until Day 28. 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. The primary indicator used for effectiveness will be Brief Pain Inventory (BPi) scores. The safety indicator will be incidence of adverse events (AEs) and incidence of discontinuation due to AE.

Inclusion Criteria:

• Patient with histological confirmed malignancy
• Patient on stable 50 mg dose morphine or 25 mg 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
• Patients with signed informed consent

Exclusion Criteria:

• Patient intolerant or hypersensitive to hydromorphone or other opioid agonist
• Patient with unstable medical condition
• Renal dysfunction
• Liver dysfunction
• Patient dependence to opiates
• Inability to take oral medication
• History of surgical procedures and/or underlying disease that would result in the narrowing of the gastrointestinal tract, or have blind loops of the tract or obstruction
• Patient taking monoamine oxidase inhibitors (MAOls) for the past 14 days prior to screening
• Patient with status asthmaticus
• Patient with chronic obstructive pulmonary disease (COPD) history
• Patient with hydromorphone therapy history
• Pregnant or breast feeding
• Patient participating in a trial 30 days prior to screening