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
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Hydromorphone HCI OROS
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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).


Enrollment: 400
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hydromorphone HCI OROS 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.

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532895

Locations
Korea, Republic of
Ansan, Korea, Republic of
Busan, Korea, Republic of
Cheongju, Korea, Republic of
Daegu, Korea, Republic of
Hwasun Gun, Korea, Republic of
Incheon, Korea, Republic of
Pusan, Korea, Republic of
Seognam-Si, Kyungki-Do, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Wonju-Shi, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01532895     History of Changes
Other Study ID Numbers: CR100741, 42801PAI4013, HYD-KOR-5011
Study First Received: February 10, 2012
Last Updated: March 15, 2014
Health Authority: South Korea: Institutional Review Board
Republic of Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Pain
Cancer pain
Hydromorphone
Hydromorphone OROS
Narcotic analgesics
Opioid-naive

Additional relevant MeSH terms:
Hydromorphone
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 17, 2014