Safety and Tolerability of Long-term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain

• Status: Completed
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

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 secondary purpose was to characterize the effects of pain on the patients' quality of life with long-term, repeated dosing of OROS hydromorphone (slow release) taken by patients with chronic cancer pain.

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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