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An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain

Primary Purpose

Cancer Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Hydromorphone
Sponsored by
Janssen Korea, Ltd., Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Pain focused on measuring Cancer pain, Hydromorphone OROS, Jurnista

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants who are currently receiving strong opioid analgesic (drug used to control pain) for their cancer pain management
  • Participants whose arithmetical mean of sleep disturbance caused by pain measured with Numeric Rating Scale for 3 days before Visit 2 (Day 1) is equal to or greater than 4 points
  • Participants who are able, in the opinion of Investigator, to comply fully with the trial requirements including completion of the Korean-Brief Pain Inventory
  • Participants who have signed an informed consent form

Exclusion Criteria:

  • Participants with pain who are not likely to response to opioid analgesics
  • Participants who are intolerant or hypersensitive to hydromorphone
  • Participants with the following digestive tract diseases which is serious enough to interfere action of an oral analgesic; diseases which can affect absorption and transit of oral drugs such as dysphagia (trouble swallowing), vomiting, no bowel movement, intestinal obstruction, serious intestinal stenosis (narrowing of a duct, tube, or 1 of the valves in the heart), etc
  • Female participants of childbearing potential who are pregnant or lactating, seeking pregnancy, or failing to take adequate contraceptive precautions
  • Participants in whom the risks of treatment with morphine/hydromorphone outweigh the potential benefits, including such risk categories as raised intracranial pressure, hypotension, hypothyroidism, asthma, compromised respiratory function compromised liver function, convulsive (an involuntary contraction or series of contractions of the voluntary muscles) disorder and Addison disease (disorder that occurs when the adrenal glands do not produce enough of their hormones)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hydromorphone OROS

    Arm Description

    Participants will receive hydromorphone OROS (8 milligram [mg] up to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS will be continued as per Investigator's discretion for additional 84 days of extension phase.

    Outcomes

    Primary Outcome Measures

    Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain
    Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.

    Secondary Outcome Measures

    Sleep Disturbance Questionnaire: Analgesic Administration
    The Investigator evaluated sleep disturbance through the participant's answers to below question in "yes" or "no" response: 'Did you need to take an analgesic for pain relief in order to go to sleep last night?'
    Sleep Disturbance Questionnaire: Frequency of Waking Up
    The Investigator evaluated sleep disturbance through the participant's answers to below question: How many times did you wake up while sleeping late night (frequency [once, 2 times, 3 times, 4 times, 5 times, couldn't fall asleep at all] of waking up due to pain last night).
    Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain
    The Investigator evaluated sleep disturbance through the participant's answers to below question in "yes" or "no" response: 'Did you wake up because of unbearable pain this morning?'
    Korean Brief Pain Inventory (K-BPI) Questionnaire Score
    K-BPI is a questionnaire designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of 9 items out of which 6 items were assessed. Score of each item ranges from 0 to 10, where 0=no pain/impact and 10=severe pain/impact. The 6 items that were assessed are: a) level of pain worst in last 24 hours; b) level of pain weakest in last 24 hours; c) level of pain average in last 24 hours; d) level of pain right now; e) how much pain reduced with the therapy taken; sixth item was further classified into 7 categories: i) general activities ii) mood iii) ambulatory ability iv) routine works v) interpersonal relation vi) sleep vii) life enjoyment.
    Participant's Pain Intensity
    Participant's pain intensity was measured using NRS ranging from 0=no pain to 10=unimaginable extreme pain. Participants maintained pain diary for 3 days before Baseline until Day 15 and pain intensity was measured twice daily (morning and afternoon). Here average pain intensity is reported. Average pain intensity was calculated as mean of morning pain intensity and evening pain intensity for each baseline and Day 15.
    Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain
    The participants recorded the frequency of short acting opioid analgesic taken for treating breakthrough pain among the pains suffered by the participants. Here frequency means number of times the short-acting opioid analgesic administered for breakthrough pain from baseline to Day 15
    Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
    The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. ECOG performance status score ranges from Grade 0 to 4, where Grade 0=Fully active, Grade 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2=ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3=capable of only limited self-care, confined to bed or chair, and Grade 4=completely disabled.
    Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score
    The CGI-Improvement score evaluates how much the participant's condition is improved compared to Baseline. The score ranges from 1 to 7, where 1=improved very much, 2=Improved much, 3=Improved a little, 4=No change, 5=Aggravated a little,6=Aggravated much and 7=aggravated very much.
    Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants
    Participants evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.
    Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators
    Investigator evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.
    Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug
    Participant's preferences between the oral long-action opioids analgesic and the study drug was reported.
    Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
    Participants reasons for preference between the long acting oral opioid analgesic and the study drug administered were reported. Reasonos for preferences were "I experienced a certain pain relief effect during the administration of the drug", "I didn't wake up due to pain while sleeping", "It was more convenient because the number of administrations was reduced", "I could reduce the administration of short acting narcotic analgesic to treat breakthrough pain" and "other".

    Full Information

    First Posted
    October 3, 2008
    Last Updated
    September 13, 2013
    Sponsor
    Janssen Korea, Ltd., Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00766831
    Brief Title
    An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain
    Official Title
    Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Janssen Korea, Ltd., Korea

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this is study to evaluate improvement of sleep disorder caused by cancer pain after the administration of Hydromorphone Oral Osmotic System (OROS) in Korean participants with cancer.
    Detailed Description
    This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) dose-ascending study to evaluate the clinical usefulness of hydromorphone OROS in improvement of sleep disturbance caused by cancer pain.Total duration of study will be 3 weeks. The study consists of 3 phases: Screening phase (up to 1 week), Treatment phase (2 weeks), and Extension phase (12 weeks). The study will include 6 visits: Day -7, Day 1, Day 15, Day 43, Day 71, and Day 99. During screening phase, potential participants will receive strong oral (long acting) opioid analgesic (for 7 days) until Day 1 and the participants will be evaluated for participation in clinical study on Day 1. During treatment phase, participants will receive hydromorphone OROS (8 milligram [mg] to greater than or equal to 32 mg), once daily for 2 weeks, and the dose will be adjusted every 2 days from Day 3 at the Investigator's discretion and according to the strong oral (long acting) opioid analgesic administered from screening phase to Day 1 (the initial dose of the study drug will be determined by converting the dose of the previously administered analgesic to that of the daily dose of oral morphine with the equivalent analgesic effect to the study drug [dose with equivalent analgesic effect; Hydromorphone OROS dose: oral morphine dose =1:5]). Participants who completed treatment phase and suffer from continuing cancer pain will be enrolled to extension phase and study drug will be administered as per Investigator discretion for 99 days. Participants primarily will be evaluated for improvement in sleep disturbance measured by Korean Brief Pain Inventory (KBPI). Participants' safety will be monitored throughout the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Pain
    Keywords
    Cancer pain, Hydromorphone OROS, Jurnista

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    190 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydromorphone OROS
    Arm Type
    Experimental
    Arm Description
    Participants will receive hydromorphone OROS (8 milligram [mg] up to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS will be continued as per Investigator's discretion for additional 84 days of extension phase.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydromorphone
    Other Intervention Name(s)
    Jurnista
    Intervention Description
    Participants will receive hydromorphone OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS will be continued as per Investigator's discretion for additional 84 days of extension phase.
    Primary Outcome Measure Information:
    Title
    Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain
    Description
    Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.
    Time Frame
    Day 15 or Early withdrawal
    Secondary Outcome Measure Information:
    Title
    Sleep Disturbance Questionnaire: Analgesic Administration
    Description
    The Investigator evaluated sleep disturbance through the participant's answers to below question in "yes" or "no" response: 'Did you need to take an analgesic for pain relief in order to go to sleep last night?'
    Time Frame
    Baseline and Day 15
    Title
    Sleep Disturbance Questionnaire: Frequency of Waking Up
    Description
    The Investigator evaluated sleep disturbance through the participant's answers to below question: How many times did you wake up while sleeping late night (frequency [once, 2 times, 3 times, 4 times, 5 times, couldn't fall asleep at all] of waking up due to pain last night).
    Time Frame
    Baseline and Day 15
    Title
    Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain
    Description
    The Investigator evaluated sleep disturbance through the participant's answers to below question in "yes" or "no" response: 'Did you wake up because of unbearable pain this morning?'
    Time Frame
    Baseline and Day 15
    Title
    Korean Brief Pain Inventory (K-BPI) Questionnaire Score
    Description
    K-BPI is a questionnaire designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of 9 items out of which 6 items were assessed. Score of each item ranges from 0 to 10, where 0=no pain/impact and 10=severe pain/impact. The 6 items that were assessed are: a) level of pain worst in last 24 hours; b) level of pain weakest in last 24 hours; c) level of pain average in last 24 hours; d) level of pain right now; e) how much pain reduced with the therapy taken; sixth item was further classified into 7 categories: i) general activities ii) mood iii) ambulatory ability iv) routine works v) interpersonal relation vi) sleep vii) life enjoyment.
    Time Frame
    Baseline and Day 15
    Title
    Participant's Pain Intensity
    Description
    Participant's pain intensity was measured using NRS ranging from 0=no pain to 10=unimaginable extreme pain. Participants maintained pain diary for 3 days before Baseline until Day 15 and pain intensity was measured twice daily (morning and afternoon). Here average pain intensity is reported. Average pain intensity was calculated as mean of morning pain intensity and evening pain intensity for each baseline and Day 15.
    Time Frame
    Baseline and Day 15
    Title
    Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain
    Description
    The participants recorded the frequency of short acting opioid analgesic taken for treating breakthrough pain among the pains suffered by the participants. Here frequency means number of times the short-acting opioid analgesic administered for breakthrough pain from baseline to Day 15
    Time Frame
    Baseline and Day 15
    Title
    Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
    Description
    The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. ECOG performance status score ranges from Grade 0 to 4, where Grade 0=Fully active, Grade 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2=ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3=capable of only limited self-care, confined to bed or chair, and Grade 4=completely disabled.
    Time Frame
    Baseline and Day 15
    Title
    Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score
    Description
    The CGI-Improvement score evaluates how much the participant's condition is improved compared to Baseline. The score ranges from 1 to 7, where 1=improved very much, 2=Improved much, 3=Improved a little, 4=No change, 5=Aggravated a little,6=Aggravated much and 7=aggravated very much.
    Time Frame
    Day 15
    Title
    Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants
    Description
    Participants evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.
    Time Frame
    Day 15
    Title
    Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators
    Description
    Investigator evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.
    Time Frame
    Day 15
    Title
    Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug
    Description
    Participant's preferences between the oral long-action opioids analgesic and the study drug was reported.
    Time Frame
    Day 15
    Title
    Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
    Description
    Participants reasons for preference between the long acting oral opioid analgesic and the study drug administered were reported. Reasonos for preferences were "I experienced a certain pain relief effect during the administration of the drug", "I didn't wake up due to pain while sleeping", "It was more convenient because the number of administrations was reduced", "I could reduce the administration of short acting narcotic analgesic to treat breakthrough pain" and "other".
    Time Frame
    Day 15

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants who are currently receiving strong opioid analgesic (drug used to control pain) for their cancer pain management Participants whose arithmetical mean of sleep disturbance caused by pain measured with Numeric Rating Scale for 3 days before Visit 2 (Day 1) is equal to or greater than 4 points Participants who are able, in the opinion of Investigator, to comply fully with the trial requirements including completion of the Korean-Brief Pain Inventory Participants who have signed an informed consent form Exclusion Criteria: Participants with pain who are not likely to response to opioid analgesics Participants who are intolerant or hypersensitive to hydromorphone Participants with the following digestive tract diseases which is serious enough to interfere action of an oral analgesic; diseases which can affect absorption and transit of oral drugs such as dysphagia (trouble swallowing), vomiting, no bowel movement, intestinal obstruction, serious intestinal stenosis (narrowing of a duct, tube, or 1 of the valves in the heart), etc Female participants of childbearing potential who are pregnant or lactating, seeking pregnancy, or failing to take adequate contraceptive precautions Participants in whom the risks of treatment with morphine/hydromorphone outweigh the potential benefits, including such risk categories as raised intracranial pressure, hypotension, hypothyroidism, asthma, compromised respiratory function compromised liver function, convulsive (an involuntary contraction or series of contractions of the voluntary muscles) disorder and Addison disease (disorder that occurs when the adrenal glands do not produce enough of their hormones)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Korea, Ltd. Clinical Trial
    Organizational Affiliation
    Janssen Korea, Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain

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