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.
20 Years
N/A
Both
Cancer Pain
Trial Information
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.
Inclusion Criteria:
- Cancer pain and require opioid analgesics
- Average pain intensity measured at the baseline (patient's medical status before any
treatment or research is done) for the past 24 hours over Numeric Rating Scale (NRS)
is 4
- Never taken continuous-type strong opioid analgesics
- Must be post-menopausal or if pre-menopausal, must use an acceptable method of birth
control
Exclusion Criteria:
- Acute digestion related disease, such as dysphagia (difficulty in swallowing),
vomiting, no enterokinesia (movements of intestine), intestinal obstruction, acute
intestinal stricture (narrowing of a passageway)
- Expected to undergo radioactive treatment (radiation therapy) between Day 1 and Day
15 of study
- Being administered with monoamine oxidase inhibitor (eg, moclobemide, selegiline,
toloxatone, etc) or within 2 weeks of administration thereof
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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)
Outcome Description:
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).
Outcome Time Frame:
up to 17 days
Safety Issue:
No
Principal Investigator
Janssen Korea, Ltd Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Janssen Korea, Ltd
Authority:
South Korea : Korea Food and Drug Administration
Study ID:
CR100659
NCT ID:
NCT01621100
Start Date:
December 2011
Completion Date:
September 2012
Related Keywords:
- Cancer Pain
- Cancer pain
- OROS
- Osmotic release oral system
- Hydromorphone
- Painkiller
- Opioid analgesic
- Korean patients
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