Cancer Pain
Conditions
Keywords
Cancer pain, Hydromorphone OROS, Jurnista
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.
Interventions
DRUGHydromorphone
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.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain | Day 15 or Early withdrawal | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance Questionnaire: Frequency of Waking Up | Baseline and Day 15 | 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 | Baseline and Day 15 | 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 | Baseline and Day 15 | 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 | Baseline and Day 15 | 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 | 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 |
| Sleep Disturbance Questionnaire: Analgesic Administration | Baseline and Day 15 | 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?' |
| Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score | Day 15 | 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 | Day 15 | 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 | Day 15 | 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 | Day 15 | 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 | Day 15 | 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. |
| Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score | Baseline and 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydromorphone OROS 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. | 190 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 20 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Non cooperation by participants | 14 |
| Overall Study | Other | 28 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Protocol Violation | 15 |
| Overall Study | Withdrawal by Subject | 4 |
| Overall Study | Withdrawal of consent | 26 |
Baseline characteristics
| Characteristic | Hydromorphone OROS |
|---|---|
| Age Continuous | 56.1 Years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 90 / 120 |
| serious Total, serious adverse events | 22 / 120 |
Outcome results
Primary
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.
Time frame: Day 15 or Early withdrawal
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydromorphone OROS | Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain | 34.9 Percentage of treatment response |
Secondary
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.
Time frame: Baseline and Day 15
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Worst pain in last 24 hours (n=74) | 6.7 Units on a scale | Standard Deviation 1.9 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Weakest pain in last 24 hours (n=74) | 3.6 Units on a scale | Standard Deviation 2.1 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Average pain in last 24 hours (n=74) | 5.2 Units on a scale | Standard Deviation 1.6 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Level of pain right now (n=76) | 4.4 Units on a scale | Standard Deviation 1.8 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Pain reduced from therapy taken (n=76) | 0.4 Units on a scale | Standard Deviation 0.3 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: General activities (n=76) | 5.0 Units on a scale | Standard Deviation 2 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Mood (n=76) | 5.1 Units on a scale | Standard Deviation 2 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Ambulatory ability (n=75) | 5.0 Units on a scale | Standard Deviation 2.3 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Routine works (n=76) | 5.6 Units on a scale | Standard Deviation 2.2 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Interpersonal relation (n=76) | 4.8 Units on a scale | Standard Deviation 2.6 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Sleep (n=76) | 5.9 Units on a scale | Standard Deviation 1.8 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Baseline: Life enjoyment (n=76) | 5.5 Units on a scale | Standard Deviation 2.5 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Worst pain in last 24 hours (n=75) | 5.4 Units on a scale | Standard Deviation 2 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Weakest pain in last 24 hours (n=75) | 2.9 Units on a scale | Standard Deviation 1.9 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Average pain in last 24 hours (n=74) | 4.1 Units on a scale | Standard Deviation 1.9 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Level of pain right now (n=75) | 3.7 Units on a scale | Standard Deviation 2 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Pain reduced from therapy taken (n=75) | 0.5 Units on a scale | Standard Deviation 0.3 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: General activities (n=75) | 5.0 Units on a scale | Standard Deviation 2 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Mood (n=75) | 4.6 Units on a scale | Standard Deviation 2.3 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Ambulatory ability (n=75) | 4.5 Units on a scale | Standard Deviation 2.6 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Routine works (n=75) | 4.9 Units on a scale | Standard Deviation 2.4 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Interpersonal relation (n=76) | 4.6 Units on a scale | Standard Deviation 2.7 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Sleep (n=74) | 4.2 Units on a scale | Standard Deviation 2.5 |
| Hydromorphone OROS | Korean Brief Pain Inventory (K-BPI) Questionnaire Score | Day 15: Life enjoyment (n=75) | 5.0 Units on a scale | Standard Deviation 2.6 |
Secondary
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.
Time frame: Day 15
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone OROS | Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators | Not effective | 7 Participants |
| Hydromorphone OROS | Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators | Average | 32 Participants |
| Hydromorphone OROS | Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators | Effective | 32 Participants |
| Hydromorphone OROS | Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators | Very effective | 10 Participants |
| Hydromorphone OROS | Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators | Extremely effective | 1 Participants |
Secondary
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.
Time frame: Day 15
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone OROS | Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants | Not effective | 7 Participants |
| Hydromorphone OROS | Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants | Average | 29 Participants |
| Hydromorphone OROS | Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants | Effective | 38 Participants |
| Hydromorphone OROS | Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants | Very effective | 8 Participants |
Secondary
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.
Time frame: Day 15
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone OROS | Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score | Improved very much | 1 Participants |
| Hydromorphone OROS | Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score | Improved much | 21 Participants |
| Hydromorphone OROS | Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score | Improved a little | 37 Participants |
| Hydromorphone OROS | Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score | No change | 20 Participants |
| Hydromorphone OROS | Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score | Aggravated a little | 2 Participants |
| Hydromorphone OROS | Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score | Aggravated much | 1 Participants |
Secondary
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.
Time frame: Baseline and Day 15
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone OROS | Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score | Baseline: Grade 0 | 1 Participants |
| Hydromorphone OROS | Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score | Baseline: Grade 1 | 53 Participants |
| Hydromorphone OROS | Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score | Baseline: Grade 2 | 23 Participants |
| Hydromorphone OROS | Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score | Baseline: Grade 3 | 4 Participants |
| Hydromorphone OROS | Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score | Baseline: Grade 4 | 1 Participants |
| Hydromorphone OROS | Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score | Day 15: Grade 1 | 52 Participants |
| Hydromorphone OROS | Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score | Day 15: Grade 2 | 22 Participants |
| Hydromorphone OROS | Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score | Day 15: Grade 3 | 5 Participants |
| Hydromorphone OROS | Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score | Day 15: Grade 4 | 3 Participants |
Secondary
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
Time frame: Baseline and Day 15
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydromorphone OROS | Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain | Baseline | 0.92 Frequency of breakthrough pain drug | Standard Deviation 1.29 |
| Hydromorphone OROS | Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain | Day 15 | 0.36 Frequency of breakthrough pain drug | Standard Deviation 0.93 |
Secondary
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.
Time frame: Baseline and Day 15
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydromorphone OROS | Participant's Pain Intensity | Baseline | 5.3 Units on a scale | Standard Deviation 1.7 |
| Hydromorphone OROS | Participant's Pain Intensity | Day 15 | 4.1 Units on a scale | Standard Deviation 1.8 |
Secondary
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.
Time frame: Day 15
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone OROS | Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug | Hydromorphone hydrochloride OROS tablets | 80.5 Percentage of participants |
| Hydromorphone OROS | Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug | Previously administered strong opioid analgesic | 19.5 Percentage of participants |
Secondary
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.
Time frame: Day 15
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone OROS | Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug | Hydromorphone OROS: pain relief | 1.5 Percentage of participants |
| Hydromorphone OROS | Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug | Previously administered analgesic: pain relief | 37.5 Percentage of participants |
| Hydromorphone OROS | Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug | Hydromorphone OROS: couldn't wake up | 31.8 Percentage of participants |
| Hydromorphone OROS | Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug | Previously administered analgesic:couldn | 50.0 Percentage of participants |
| Hydromorphone OROS | Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug | Hydromorphone OROS: reduced doses | 54.6 Percentage of participants |
| Hydromorphone OROS | Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug | Previously administered analgesic: reduced doses | 12.5 Percentage of participants |
| Hydromorphone OROS | Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug | Hydromorphone OROS: could reduce administration | 12.1 Percentage of participants |
| Hydromorphone OROS | Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug | Previously taken analgesic: reduce administration | 0 Percentage of participants |
Secondary
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?'
Time frame: Baseline and Day 15
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Analgesic Administration | Baseline : Yes | 37 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Analgesic Administration | Baseline: No | 45 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Analgesic Administration | Day 15: Yes | 25 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Analgesic Administration | Day 15: No | 57 Participants |
Secondary
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).
Time frame: Baseline and Day 15
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Frequency of Waking Up | Baseline: once (n=77) | 8 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Frequency of Waking Up | Baseline: 2 times (n=77) | 29 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Frequency of Waking Up | Baseline: 3 times (n=77) | 21 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Frequency of Waking Up | Baseline: 4 times (n=77) | 6 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Frequency of Waking Up | Day 15: once (n=58) | 23 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Frequency of Waking Up | Day 15: 2 times (n=58) | 17 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Frequency of Waking Up | Day 15: 3 times (n=58) | 7 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Frequency of Waking Up | Day 15: 4 times (n=58) | 7 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Frequency of Waking Up | Day 15: 5 times (n=58) | 4 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Frequency of Waking Up | Baseline: 5 times (n=77) | 13 Participants |
Secondary
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?'
Time frame: Baseline and Day 15
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain | Baseline: Yes | 32 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain | Baseline: No | 50 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain | Day 15: Yes | 15 Participants |
| Hydromorphone OROS | Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain | Day 15: No | 67 Participants |