Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance
Effective pain relief and high sleep quality allow patients to resume active lives and be
themselves. This is multicenter, prospective, open-label, single-arm, dose-ascending study
to evaluate the clinical usefulness of hydromorphone OROS in improvement of sleep
disturbance provoked by cancer pain. Patient who took oral opioid previously will be
administered the study drug for two weeks. Primary Endpoint is improvement of the degree of
sleep disturbance as measured by the K-BPI (question 9). Secondary Endpoint are as follows:
K-BPI (Korean Brief Pain Inventory: 9-questionnaire, 11-point scale), Pain intensity at
morning and afternoon, Number of breakthrough pain medication, Investigator and patient
global assessments: 5-pint rating scale, Patient's preference, CGI-I (Clinical Global
Impression - Improvement: 7 point rating scale), Safety evaluation(adverse event &
tolerance) Initial Dose of Hydromorphone OROS: At second visit, initial dose of
hydromorphone will be determined according to the equivalent analgesic effect conversion
table. Subject will administer hydromorphone at 10 AM. At Change of Hydromorphone dose: The
investigator will increase a patient's daily dose if more than 3 breakthrough pain episodes
requiring rescue medication occurred within 24 hours. Daily doses will be titrated up to the
next higher dose level every 2 days after phone call
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Improvement of the degree of sleep disturbance as measured by the K-BPI (question 9)
Janssen Korea, Ltd. Clinical Trial
Study Director
Janssen Korea, Ltd.
Korea: Food and Drug Administration
CR014806
NCT00766831
October 2008
June 2010
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