Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Cancer Pain

Dyssomnias

Parasomnias

Pain

Neurologic Manifestations

Analgesics

All Drugs and Chemicals

Central Nervous System Depressants

Morphine

Hydromorphone

Analgesics, Opioid

Narcotics

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.

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.

Janssen Korea, Ltd. Clinical Trial

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.

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.

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

Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance

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.

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?'

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).

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?'

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 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.

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

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.

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.

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.

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.

Participant's preferences between the oral long-action opioids analgesic and the study drug was reported.

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".

Janssen Korea, Ltd., Korea

Safety analysis population included all the participants who received at least 1 dose of study medication

Participants received hydromorphone oral osmotic system 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 was continued as per Investigator's discretion for additional 84 days of extension phase.

Hydromorphone OROS

Age Continuous

Sex: Female, Male

Clinical Research Associate

Intent to treat (ITT) population included all the participants who received study medication at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.

Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain

Baseline : Yes

Baseline: No

Day 15: Yes

Day 15: No

ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.

Sleep Disturbance Questionnaire: Analgesic Administration

Baseline: once (n=77)

Baseline: 2 times (n=77)

Baseline: 3 times (n=77)

Baseline: 4 times (n=77)

Baseline: 5 times (n=77)

Day 15: once (n=58)

Day 15: 2 times (n=58)

Day 15: 3 times (n=58)

Day 15: 4 times (n=58)

Day 15: 5 times (n=58)

ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies participants who were evaluated for this outcome measure at a particular time point.

Sleep Disturbance Questionnaire: Frequency of Waking Up

Baseline: Yes

Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain

Baseline: Worst pain in last 24 hours (n=74)

Baseline: Weakest pain in last 24 hours (n=74)

Baseline: Average pain in last 24 hours (n=74)

Baseline: Level of pain right now (n=76)

Baseline: Pain reduced from therapy taken (n=76)

Baseline: General activities (n=76)

Baseline: Mood (n=76)

Baseline: Ambulatory ability (n=75)

Baseline: Routine works (n=76)

Baseline: Interpersonal relation (n=76)

Baseline: Sleep (n=76)

Baseline: Life enjoyment (n=76)

Day 15: Worst pain in last 24 hours (n=75)

Day 15: Weakest pain in last 24 hours (n=75)

Day 15: Average pain in last 24 hours (n=74)

Day 15: Level of pain right now (n=75)

Day 15: Pain reduced from therapy taken (n=75)

Day 15: General activities (n=75)

Day 15: Mood (n=75)

Day 15: Ambulatory ability (n=75)

Day 15: Routine works (n=75)

Day 15: Interpersonal relation (n=76)

Day 15: Sleep (n=74)

Day 15: Life enjoyment (n=75)

ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies the number of participant who were evaluated for particular category at particular time point.

Korean Brief Pain Inventory (K-BPI) Questionnaire Score

Baseline

Day 15

Participant's Pain Intensity

ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'N' signifies participants who were evaluated for this outcome measure.

Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain

Baseline: Grade 0

Baseline: Grade 1

Baseline: Grade 2

Baseline: Grade 3

Baseline: Grade 4

Day 15: Grade 1

Day 15: Grade 2

Day 15: Grade 3

Day 15: Grade 4

Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score

Improved very much

Improved much

Improved a little

No change

Aggravated a little

Aggravated much

Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score

Not effective

Average

Effective

Very effective

ITT population included all the participants who received at least one dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.

Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants

Extremely effective

Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators

Hydromorphone hydrochloride OROS tablets

Previously administered strong opioid analgesic

ITT population included all the participants who received at least one dose of study medicaation and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.

Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug

Hydromorphone OROS: pain relief

Previously administered analgesic: pain relief

Hydromorphone OROS: couldn't wake up

Previously administered analgesic:couldn

Hydromorphone OROS: reduced doses

Previously administered analgesic: reduced doses

Hydromorphone OROS: could reduce administration

Previously taken analgesic: reduce administration

Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug

Overall Study

Spots Global Cancer Trial Database for hydromorphone oros