A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain

• Status: Terminated
• Trial end date: 2008-12-01
• 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) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Taiwan Ltd
• Treatments: Hydromorphone; Morphine; Sulfamethazine

Criteria

Inclusion Criteria:

• Participants with cancer pain and experiencing inadequate pain control on or approaching Step 2 of the World Health Organisation (WHO) analgesic ladder

• Participants with pain scores greater than and equal to 4 on the average in the last 24 hours

• Participants requiring or are expected to require not more than 540 milligram of oral morphine or morphine equivalent every 24 hours for the management of chronic cancer pain

• Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial

• Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial

Exclusion Criteria:

• Participants with pure or predominantly neuropathic pain or pain of unknown origin (where a mechanism or physical cause cannot be identified)

• Participants with acute pain or who have pain on movement

• Participants who have received a fentanyl patch within the last 5 days

• Participants intolerant or hypersensitive to hydromorphone or other opioids agonists (chemical substance capable of activating a receptor to induce a full or partial response)

• Participants with recent past history (within the previous 5 years) or current history of drug abuse or alcohol abuse