Status:
COMPLETED
A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Pain
Analgesics, Opioid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 pa...
Detailed Description
This was a phase-3, multicenter, multinational, randomized (patients are assigned different treatments based on chance), active-controlled, double-blind, multiple-ascending-dose, parallel-group study ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2001
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00410540
End Date
May 1 2001
Last Update
April 27 2010
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