Overview

Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
Summary
The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Korea, Ltd., Korea
Treatments:
Analgesics, Opioid
Hydromorphone
Criteria
Inclusion Criteria: - Patients who complain of cancer pain and who require administration
of hydromorphone HCl - Patients who can follow the requirements of the overall study,
including completion of filling out the European Organization for Research and Treatment of
Cancer Quality of Life Questionnaire, at the investigator's discretion - Signed informed
consent Exclusion Criteria: - Patients who received strong continuous narcotic analgesics
(eg morphine, fentanyl, oxycodone, hydromorphone) within 4 weeks prior to administration of
the study drug - Patients who have a medical history of receiving drugs in the past or
currently, or of drug abuse - Patients who did not agree to conduct the approved methods
for contraception during the study - Patients who have sustained injuries in physical
functions or diseases which may cause abnormalities in absorbing the study drug, excessive
accumulation and metabolic or elimination disorder - Patients who are receiving Monoamine
Oxidase Inhibitors (MAO) inhibitors or who are within 2 weeks from discontinuation -
Patients who need to be excluded based on precautions in the user manual of the study drug,
notice and contradictions, at the investigator's discretion