A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.

• Status: Completed
• Trial end date: 2001-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to demonstrate the clinical equivalence of hydromorphone and morphine (immediate-release [IR] and sustained-release [SR] formulations) using the "worst pain in the past 24 hours" item of the Brief Pain Inventory (BPI). The secondary objective of this study was to compare hydromorphone and morphine in the following variables: other pain measures, various questionnaires, and safety and tolerability variables.

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

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Hydromorphone; Morphine

Criteria

Inclusion Criteria:

• Patients with cancer pain who are currently receiving strong oral or transdermal opioid analgesics or in whom strong opioid analgesics are appropriate

• Patients who requires or are expected to require between 60 and 540 mg of oral morphine or morphine equivalents every 24 hours for the chronic management of cancer pain

• Patients who have pain suitable for treatment with a once-daily formulation

• Patients with concomitant chemotherapy or radiotherapy. Exclusion Criteria:

• Patient with gastrointestinal (GI) disease of sufficient severity to interfere with orally administered analgesia (eg dysphagia, vomiting, constipation, bowel obstruction, severe gut narrowing) were not permitted to enroll

• Patient where the risks of treatment with morphine or hydromorphone outweighed the potential benefits such as raised intracranial pressure, hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic or renal impairment, convulsive disorders, and Addison's disease

• Debilitated patients were excluded.