Overview

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