Table 1 Criteria for patient selection

• Age ≥ 18 years

• Pain not considered potentially responsive to opioids

• Presence of chronic cancer pain:

• Pain present only upon movement

   ◦ currently receiving strong oral or transdermal opioid analgesics (60–540 mg oral morphine or equivalent every 24 hours)

• Need for other opioid analgesics (except study medication and breakthrough pain medication) after randomization

   ◦ appropriate candidate for strong oral or transdermal opioid analgesics (anticipated requirement, 60–540 mg oral morphine or equivalent every 24 hours)

• Current or recent (within 6 months) history of drug and/or alcohol abuse

• Pain suitable for treatment with a once-daily formulation

• Women of childbearing potential who are pregnant or lactating, seeking pregnancy, or failing to take adequate contraceptive precautions

• Intolerance of, or hypersensitivity to, hydromorphone or other opioids

• Presence of GI disease of sufficient severity to likely interfere with oral analgesia (e.g., dysphagia, vomiting, no bowel movement or bowel obstruction due to impaction within 5 days of study entry, severe gut narrowing that may affect analgesic absorption or transit)

• Use of monoamine oxidase inhibitors within 2 weeks prior to study entry

• Investigational drug use within 4 weeks of study entry

• Presence of conditions for which risks of opioid use outweigh potential benefits (e.g., raised intracranial pressure, hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic impairment, renal impairment, elderly and debilitated, convulsive disorders, Addison's disease)