A Prospective, Open-Label, Multicenter, Single-Arm, Interventional Study to Evaluate the Efficacy and Tolerability of Once-Daily Oros Hydromorphone for Cancer Pain Treatment in Korean Cancer Patients.
This is a prospective (expected to happen), open-label (type of clinical study in which both
the researchers and participants know which treatment is being administered), multicenter
(conducted at multiple centers), single-arm (only one group), study to evaluate the
effectiveness and tolerability (capable to tolerate) of Once-Daily OROS hydromorphone for
cancer pain treatment. This is a 14-week study consisting of 2-week efficacy evaluation
period (1st evaluation on Day 1 and 2nd evaluation on Days 15±2) and a 12-week extension
phase. 99 patients will receive Once-Daily OROS hydromorphone for 2 weeks .After 2 weeks, if
a patient has continuous cancer pain and the investigator deems it necessary to administer
the same medicine as the study medication then the patient may participate voluntarily in
the 12 weeks extension phase. At the extension phase, other continuous-type strong opioid
analgesics (painkiller) may be administered at the same time for the adjustment of cancer
pain based on the discretion of the investigator.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with 50% or more average Pain Intensity Difference (PID) from 1st evaluation day (Day 1) to the 2nd evaluation day (Days 15±2)
Average pain intensity is calculated (on 1st and 2nd evaluation days) for the past 24 hours of the patient using the NRS (Numeric Rating Scale) (0 = No pain, 10 = Unimaginably acute pain). PID (pain intensity difference) %= [NRS (1st evaluation day) - NRS (2nd evaluation day)]/ NRS (1st evaluation day).
up to 17 days
Janssen Korea, Ltd Clinical Trial
Janssen Korea, Ltd
South Korea : Korea Food and Drug Administration