Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients
Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer Pain
Intervention: OROS hydromorphone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Korea, Ltd., Korea Official(s) and/or principal investigator(s): Janssen Korea, Ltd Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd
Summary
The purpose of this study is to evaluate the effectiveness and tolerability of Once-Daily
OROS ("Osmotic Release Oral System" [a controlled release oral medication delivery system in
the form of a tablet]) hydromorphone for cancer pain treatment in Korean cancer patients.
Clinical Details
Official title: 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.
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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)
Secondary outcome: Korean Brief Pain Inventory (K-BPI) scoresEuropean Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) scores Patient's Global Assessment (PGA) scores Investigator's Global Assessment scores
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Cheonan City, Korea, Republic of
Cheonan, Korea, Republic of
Cheongju, Korea, Republic of
Daejeon, Korea, Republic of
Hwasun Gun, Korea, Republic of
Jeonju-Si, Korea, Republic of
Jinju-Si, Korea, Republic of
Additional 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
Starting date: December 2011
Last updated: September 5, 2013
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