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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01532895
First received: February 10, 2012
Last updated: March 15, 2014
Last verified: March 2014

February 10, 2012
March 15, 2014
September 2011
September 2012   (final data collection date for primary 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 [ Time Frame: Baseline and at approximately Day 57 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01532895 on ClinicalTrials.gov Archive Site
  • Changes in the Karnofsky Performance Rating Scale (KPRS) [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    The KPRS measures the physical functions of cancer patients, and indicates the feasibility of daily life by 10% units from 0% (death) to 100% (normal status in which patients can do activities to the level before disease without limitations).
  • Change in pain relief (%) [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    How much pain was relieved by the pain therapy or medication for the last 24 hours, using %: 0%= nothing reduced and 100%= completely reduced.
  • Frequency of awakening [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    Check whether patients experienced awakening during sleep caused by pain for the last 1 week or not, and measure the frequency (1 = once, 2 = twice, 3 = 3 times, 4 = more than 4 times, 5 = not woken, 6 = never slept).
  • Level of sleep inconvenience [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    Measure the level of sleep inconvenience that patients experienced due to pain for the last 1 week using the Numeric Rating Scale (NRS); 0 = not causing inconvenience, 10 = completely causing inconvenience.
  • Satisfaction with sleep [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    Indicate the overall satisfaction with sleep by improving sleep disturbance caused by pain for the last 1 week using the Numeric Rating Scale (0 "never satisfied" on the left end; 10 "very satisfied" on the right end).
  • Quality of life assessment measured by the EORTC QLQ-C15 PAL [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    The EORTC (European Organization for Research and Treatment of Cancer) QLQ-C15 (Quality of Life Questionnaire Core 15) is a commonly used questionnaire to assess the quality of life of cancer patients taking paliative medicine. This questionnaire consists of questions measuring physical, role, emotional, cognitive and social functions, and answers are given based on a 4-point scale, from 1 (not at all) to 4 (very much so).
  • Investigator's Global Assessment [ Time Frame: At approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    The investigator's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the investigator from the investigator's point of view as 1 = not effective, 2 = normal l, 3 = effective, 4 very effective, and 5 = extremely effective.
  • Patient's Global Assessment [ Time Frame: At approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    The patient's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the patient from the patient's point of view as 1 = not effective, 2 = normal, 3 = effective, 4 = very effective, and 5 = extremely effective.
  • CGI-I (Clinical Global Impression - Improvement) [ Time Frame: At approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    Evaluate how much patients have improved compared with the conditions of patients at baseline, from 1 (very much improved) to 7 (greatly deteriorated).
  • Changes in the Karnofsky Performance Rating Scale (KPRS) [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    The KPRS measures the physical functions of cancer patients, and indicates the feasibility of daily life by 10% units from 0% (death) to 100% (normal status in which patients can do activities to the level before disease without limitations).
  • Change in pain relief (%) [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    How much pain was relieved by the pain therapy or medication for the last 24 hours, using %: 0%= nothing reduced and 100%= completely reduced.
  • Frequency of awakening [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    Check whether patients experienced awakening during sleep caused by pain for the last 1 week or not, and measure the frequency (1 = once, 2 = twice, 3 = 3 times, 4 = more than 4 times, 5 = not woken, 6 = never slept).
  • Level of sleep inconvenience [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    Measure the level of sleep inconvenience that patients experienced due to pain for the last 1 week using the Numeric Rating Scale (NRS); 0 = not causing inconvenience, 10 = completely causing inconvenience.
  • Satisfaction with sleep [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    Indicate the overall satisfaction with sleep by improving sleep disturbance caused by pain for the last 1 week using the Numeric Rating Scale (0 "never satisfied" on the left end; 10 "very satisfied" on the right end).
  • Quality of life assessment measured by the EORTC QLQ-C15 PAL [ Time Frame: Baseline, and at approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    The EORTC (European Organization for Research and Treatment of Cancer) QLQ-C15 (Quality of Life Questionnaire Core 15) is a commonly used questionnaire to assess the quality of life of cancer patients taking paliative medicine. This questionnaire consists of questions measuring physical, role, emotional, cognitive and social functions, and answers are given based on a 4-point scale, from 1 (not at all) to 4 (very much so).
  • Investigator's Global Assessment [ Time Frame: At approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    The investigator's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the investigator from the investigator's point of view as 1 = not effective, 2 = normal l, 3 = effective, 4 very effective, and 5 = extremely effective.
  • Patient's Global Assessment [ Time Frame: At approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    The patient's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the patient from the patient's point of view as 1 = not effective, 2 = normal, 3 = effective, 4 = very effective, and 5 = extremely effective.
  • CGI-I (Clinical Global Impression - Improvement) [ Time Frame: At approximately Days 29 and 57 ] [ Designated as safety issue: No ]
    Evaluate how much patients have improved compared with the conditions of patients at baseline, from 1 (very much improved) to 7 (greatly deteriorated).
Not Provided
Not Provided
 
Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid
Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Korean cancer patients having cancer pain who visit or are hospitalized at the research centers during the study.

Pain
Drug: Hydromorphone HCI OROS
type= exact number, unit= mg, number=4, form= tablet, route= oral use. One tablet administered once a day. The dose may be increased if the level of pain increases or if the pain-killing effect is insufficient.
Hydromorphone HCI OROS
Intervention: Drug: Hydromorphone HCI OROS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
October 2012
September 2012   (final data collection date for primary outcome measure)

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

Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01532895
CR100741, 42801PAI4013, HYD-KOR-5011
No
Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
Not Provided
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP