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Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study


Phase 4
20 Years
N/A
Not Enrolling
Both
Pain

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Trial Information

Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The ratio of patients with % PID (Pain Intensity Difference) over 30% of patients from the first evaluation date until the third evaluation date, following the administration of hydromorphone HCI to cancer pain patients

Outcome Time Frame:

Baseline and at approximately Day 57

Safety Issue:

No

Principal Investigator

Janssen Korea, Ltd., Korea Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Korea, Ltd., Korea

Authority:

South Korea: Institutional Review Board

Study ID:

CR100741

NCT ID:

NCT01532895

Start Date:

September 2011

Completion Date:

October 2012

Related Keywords:

  • Pain
  • Pain
  • Cancer pain
  • Hydromorphone
  • Hydromorphone OROS
  • Narcotic analgesics
  • Opioid-naive

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