Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study
This is a multicenter, prospective, open-label (all people know the identity of the
intervention) and observational study. Patients selected for the proposed study are patients
complaining of cancer pain who visit or are hospitalized at the research centers during the
study, who are not being treated with strong continuous opioid (narcotic medication used
against the pain), and who require cancer pain control with hydromorphone, at the
investigator's discretion. The study will evaluate the changes in pain relief, level of
sleep deprivation, and the patients' quality of life before and after administration of
hydromorphone.
Observational
Observational Model: Cohort, Time Perspective: Prospective
The ratio of patients with % PID (Pain Intensity Difference) over 30% of patients from the first evaluation date until the third evaluation date, following the administration of hydromorphone HCI to cancer pain patients
Baseline and at approximately Day 57
No
Janssen Korea, Ltd., Korea Clinical Trial
Study Director
Janssen Korea, Ltd., Korea
South Korea: Institutional Review Board
CR100741
NCT01532895
September 2011
October 2012
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