Cancer Pain
Conditions
Keywords
Pain, Hydromorphone hydrochloride OROS, Morphine
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.
Detailed description
This is an open-label (all people know the identity of the intervention), multi-center (when more than 1 hospital or medical school team work on a medical research study), active-controlled, randomized (the study drug is assigned by chance) study to evaluate safety and efficacy of OROS extended-release (ER) hydromorhone HCl compared to twice daily morphine SR, in Taiwan participants with cancer pain. The study consists of 3 phases: Screening phase (14 days before administration of study drug), Dose titration phase (3 to 14 days) and Dose maintenance phase (14 days). This study will include 8 visits (Visit 1 \[Day 1\], Visit 2 \[Day 1-13 telephonic\], Visit 3 \[Day 14\], Visit 4 \[Day 15 to Day 21 telephonic\], Visit 5 \[Day 22\], Visit 6 \[Day 23 to 27 telephonic\] and Visit 7 \[Day 28\]). In dose titration phase, participants will be randomly assigned to 1 of the 2 treatments, OROS hydromorphone or morphine SR and dose of study medication will be adjusted every 48 hours at Investigator's discretion according to participant's analgesic (drug used to control pain) requirements. Morphine HCl will be used as rescue medication (maintained at 3 doses per day or less) for breakthrough pain. Participants primarily will be evaluated for equivalence of efficacy using the worst pain item of the brief pain inventory (BPI). Participants' safety will be monitored throughout the study duration.
Interventions
DRUGHydromprphone Hydrochloride (HCl) OROS
Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase.
DRUGMorphine Sustain Release (SR)
Participants will receive morphine SR 8 mg every24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.
Sponsors
Johnson & Johnson Taiwan Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with cancer pain and experiencing inadequate pain control on or approaching Step 2 of the World Health Organisation (WHO) analgesic ladder * Participants with pain scores greater than and equal to 4 on the average in the last 24 hours * Participants requiring or are expected to require not more than 540 milligram of oral morphine or morphine equivalent every 24 hours for the management of chronic cancer pain * Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial * Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial
Exclusion criteria
* Participants with pure or predominantly neuropathic pain or pain of unknown origin (where a mechanism or physical cause cannot be identified) * Participants with acute pain or who have pain on movement * Participants who have received a fentanyl patch within the last 5 days * Participants intolerant or hypersensitive to hydromorphone or other opioids agonists (chemical substance capable of activating a receptor to induce a full or partial response) * Participants with recent past history (within the previous 5 years) or current history of drug abuse or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI) Questionnaire Item 3 Worst Pain Score at Day 14 | Day 14 | The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). |
| BPI Questionnaire Item 3 Worst Pain Score at Day 28 | Day 28 | The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BPI Questionnaire Item Pain Relief Score | Baseline, Day 14, Day 22 and Day 28 | The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Relief will be assessed using the BPI questionnaire. Pain relief was rated on a scale ranging from 0% (no relief) to 100% (complete relief). |
| BPI Questionnaire Item Pain Interference Score | Baseline, Day 14, Day 22 and Day 28 | The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Interference will be assessed using the BPI questionnaire. Pain interference of general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life will be rated on a scale ranging from 0 (no interference) to 10 (complete interference). |
| Patient's Global Assessment on Effectiveness | Day 14, Day 22 and Day 28 | Participants will evaluate effectiveness by providing rating on the question 'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent. |
| BPI Questionnaire Item 6 How Much Pain You Have Right Now Score | Baseline, Day 14, Day 22 and Day 28 | The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 6 how much pain you have right now will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). |
| Number of Times the Pain Medication Required for Breakthrough Pain | Baseline up to Day 28 | The requirement of breakthrough pain medication will be recorded by participants. Morphine HCl, 10 mg, will be used as rescue medication for breakthrough pain. |
| Mean Total Daily Dose (TDD) of Study Medication | Baseline up to day 28 | Mean total daily dose of study medication taken during study will be recorded by participants. |
| Investigator's Global Assessment on Effectiveness | Day 14, Day 22 and Day 28 | Investigator will evaluate effectiveness by providing rating on the question 'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent. |
| BPI Questionnaire Item Pain Intensity Score | Baseline, Day 14, Day 22 and Day 28 | The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Intensity will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator's discretion for next 14 days of maintenance phase. | 1 |
| Morphine Sustain Release (SR) Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator's discretion for next 14 days of maintenance phase. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | Morphine Sustain Release (SR) | Total |
|---|---|---|---|
| Age, Customized >=18 to <=40 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized >=41 to <=60 years | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
BPI Questionnaire Item 3 Worst Pain Score at Day 28
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: Day 28
Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Primary
Brief Pain Inventory (BPI) Questionnaire Item 3 Worst Pain Score at Day 14
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: Day 14
Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Secondary
BPI Questionnaire Item 6 How Much Pain You Have Right Now Score
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 6 how much pain you have right now will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: Baseline, Day 14, Day 22 and Day 28
Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Secondary
BPI Questionnaire Item Pain Intensity Score
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Intensity will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: Baseline, Day 14, Day 22 and Day 28
Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Secondary
BPI Questionnaire Item Pain Interference Score
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Interference will be assessed using the BPI questionnaire. Pain interference of general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life will be rated on a scale ranging from 0 (no interference) to 10 (complete interference).
Time frame: Baseline, Day 14, Day 22 and Day 28
Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Secondary
BPI Questionnaire Item Pain Relief Score
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Relief will be assessed using the BPI questionnaire. Pain relief was rated on a scale ranging from 0% (no relief) to 100% (complete relief).
Time frame: Baseline, Day 14, Day 22 and Day 28
Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Secondary
Investigator's Global Assessment on Effectiveness
Investigator will evaluate effectiveness by providing rating on the question 'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.
Time frame: Day 14, Day 22 and Day 28
Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Secondary
Mean Total Daily Dose (TDD) of Study Medication
Mean total daily dose of study medication taken during study will be recorded by participants.
Time frame: Baseline up to day 28
Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Secondary
Number of Times the Pain Medication Required for Breakthrough Pain
The requirement of breakthrough pain medication will be recorded by participants. Morphine HCl, 10 mg, will be used as rescue medication for breakthrough pain.
Time frame: Baseline up to Day 28
Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
Secondary
Patient's Global Assessment on Effectiveness
Participants will evaluate effectiveness by providing rating on the question 'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.
Time frame: Day 14, Day 22 and Day 28
Population: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.