Clinical trial NCT01532895: Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid
Official title: Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pain
Cancer pain
Hydromorphone
Hydromorphone OROS
Narcotic analgesics
Opioid-naive
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-02-15
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean cancer patients having cancer pain who visit or are hospitalized at the research centers during the study.

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
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
timeFrame: Baseline and at approximately Day 57
Secondary outcomes:
measure: Changes in the Karnofsky Performance Rating Scale (KPRS)
timeFrame: Baseline, and at approximately Days 29 and 57
measure: Change in pain relief (%)
timeFrame: Baseline, and at approximately Days 29 and 57
measure: Frequency of awakening
timeFrame: Baseline, and at approximately Days 29 and 57
measure: Level of sleep inconvenience
timeFrame: Baseline, and at approximately Days 29 and 57
measure: Satisfaction with sleep
timeFrame: Baseline, and at approximately Days 29 and 57
measure: Quality of life assessment measured by the EORTC QLQ-C15 PAL
timeFrame: Baseline, and at approximately Days 29 and 57
measure: Investigator's Global Assessment
timeFrame: At approximately Days 29 and 57
measure: Patient's Global Assessment
timeFrame: At approximately Days 29 and 57
measure: CGI-I (Clinical Global Impression - Improvement)
timeFrame: At approximately Days 29 and 57
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Cheongju
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Hwasun Gun
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seognam-Si, Kyungki-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Wonju-Shi
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: