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Brief Title: Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients
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 ID: NCT01621100
Brief 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.
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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, 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
Name: Janssen Korea, Ltd Clinical Trial
Affiliation: Janssen Korea, Ltd
Role: STUDY_DIRECTOR