Status:
COMPLETED
Safety and Tolerability of Long-term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Analgesics, Opioid
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study was to characterize the pain control achieved with long-term repeated dosing of OROS hydromorphone (slow release) in patients with chronic cancer pain and the seconda...
Detailed Description
Study DO-118X was a phase-3, multicenter, open-label extension study in adult patients with cancer pain who had successfully completed Study DO-118 with dose-stable pain control taking at least 8 mg o...
Eligibility Criteria
Inclusion
- Patients who have chronic cancer pain, and who have successfully completed the OROS hydromorphone SR (slow release) study, DO-118
- Patients must have been in dose-stable pain control in the last two days of the slow release phase of the study
- Patients who require at least 8mg of OROS hydromorphone slow release every 24 hours for the management of chronic cancer pain
Exclusion
- Pain which is not considered to be potentially responsive to opioids
- Gastrointestinal disease of sufficient severity to be likely to interfere with oral analgesia including: dysphagia, vomiting, no bowel movement or bowel obstruction due to impaction within the 5 days prior to the start of the trial, severe gut narrowing that may affect the absorption or transit of orally administered drugs, particularly the insoluble OROS outer coating
- Any patient in whom the risks of treatment with hydromorphone outweigh the potential benefits. Such risk categories include: raised intracranial pressure, hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic impairment, renal impairment, elderly and debilitated, convulsive disorders and Addison's disease
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2002
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00410787
End Date
April 1 2002
Last Update
April 27 2010
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