An observational study in Pain, sponsored by Janssen Korea, Ltd., Korea. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-09-04.
Sponsored by Janssen Korea, Ltd., Korea · Observational
This study aims to collect clinical information and to examine the usefulness and safety of ORal Osmotic System Hydromorphone in Korean cancer patients. The decision to treat patients with drug is as per physician discretion and that doses are determined based upon approved labeling recommendations and physician discretion.
The primary purpose of this observational study is to collect clinical data on cancer pain control using OROS (ORal Osmotic Active System) hydromorphone and to investigate the clinical usefulness of OROS hydromorphone for Korean cancer patients. Information on the effectiveness of cancer pain control and any adverse events reported by those patients using OROS Hydromorphone will be reported. In addition, clinical usefulness of OROS hydromorphone will be evaluated through assessing sleep disturbance due to pain, breakthrough pain, and end-of-dose failure before and after the study drug administration and examining the patient's satisfaction with study drug and the investigator's global assessment. This is a multi-center, open-label, prospective, exploratory, and observational study with approximately 770 patients. Efficacy endpoints will be analyzed to examine the difference between before and after the treatment. Since this is an observational study under the condition of routine practice, OROS Hydromorphone dosage should be adjusted at the discretion of the investigator, based on patient response. It is recommended that the dosage be conservative at first and adjusted appropriately considering the adverse events and analgesic effect for all the patients.
Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients suffering from cancer pain who visit the study sites during study and eligible to be treated with OROS hydromorphone at the discretion of the investigator.
Exclusion Criteria:
OROS Hydromorphone 8 16 32 mg once a day for 4 weeks
Drug: OROS Hydromorphone
8,16, 32 mg once a day for 4 weeks
Change in pain intensity score (where 0 is worst and 10 is best) as measured on the Numeric Rating Scale (NRS) from baseline to Day 36
Time frame: Between Visit 1 (day 1) and the last visit (day 29 ± 7: from day 22 to day 36)
Change in sleep disturbance
Time frame: between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))
Breakthrough pain experience
Time frame: between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))
End-of-dose failure experience
Time frame: between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day))
Patient satisfaction with study drug and detailed reason
Time frame: at the last visit (DAY29 ± 7: from 22 day to 36 day))
Investigator's global assessment
Time frame: the last visit (DAY29 ± 7: from 22 day to 36 day)
No study locations are listed for this record.
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Korea, Ltd., Korea