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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Pain

Treatments: Drug: Hydromorphone HCI OROS

Study type: Observational

Funder types: Industry

Identifiers

NCT01532895

42801PAI4013 (Other Identifier)

CR100741

HYD-KOR-5011 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is a multicenter, prospective, open-label (all people know the identity of the intervention) and observational study. Patients selected for the proposed study are patients complaining of cancer pain who visit or are hospitalized at the research centers during the study, who are not being treated with strong continuous opioid (narcotic medication used against the pain), and who require cancer pain control with hydromorphone, at the investigator's discretion. The study will evaluate the changes in pain relief, level of sleep deprivation, and the patients' quality of life before and after administration of hydromorphone.

Enrollment: 400 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

400 participants in 1 patient group

Hydromorphone HCI OROS

Treatment:

Drug: Hydromorphone HCI OROS