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| ID | Type | Description | Link |
|---|---|---|---|
| 42801PAI3008 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydromprphone Hydrochloride (HCl) OROS | Experimental | 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. |
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| Morphine Sustain Release (SR) | Active Comparator | Participants will receive morphine SR 8 mg every 24 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromprphone Hydrochloride (HCl) OROS | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 14 |
| 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). | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Day 14, Day 22 and Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Taiwan, Ltd. Clinical Trial | Johnson & Johnson Taiwan Ltd | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Morphine Sustain Release (SR) | Drug | 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. |
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| 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). | Baseline, Day 14, Day 22 and Day 28 |
| 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). | Baseline, Day 14, Day 22 and Day 28 |
| 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). | Baseline, Day 14, Day 22 and Day 28 |
| 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. | Day 14, Day 22 and Day 28 |
| 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. | Day 14, Day 22 and Day 28 |
| 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. | Baseline up to Day 28 |
| Mean Total Daily Dose (TDD) of Study Medication | Mean total daily dose of study medication taken during study will be recorded by participants. | Baseline up to day 28 |
| 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | Day 14 |
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| 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). | Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | Day 28 |
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| 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). | Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | Baseline, Day 14, Day 22 and Day 28 |
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| 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). | Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | Baseline, Day 14, Day 22 and Day 28 |
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| 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). | Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | Baseline, Day 14, Day 22 and Day 28 |
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| 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). | Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | Baseline, Day 14, Day 22 and Day 28 |
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| 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. | Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | Day 14, Day 22 and Day 28 |
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| 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. | Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | Day 14, Day 22 and Day 28 |
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| 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. | Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | Baseline up to Day 28 |
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| Secondary | Mean Total Daily Dose (TDD) of Study Medication | Mean total daily dose of study medication taken during study will be recorded by participants. | Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | Baseline up to day 28 |
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Baseline up to Day 28
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 1 | 1 | 1 | ||
| EG001 | 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. | 0 | 1 | 0 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA version 15.1 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA version 15.1 | Non-systematic Assessment |
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| Chest discomfort | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA version 15.1 | Non-systematic Assessment |
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This study had inadequate number of participants. 'The study was terminated early and the data for efficacy assessments were missing.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Advisor | Janssen Taiwan | 886-2-23762158 |
| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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