A Phase 3 interventional study of Hydromprphone Hydrochloride (HCl) OROS and Morphine Sustain Release (SR) in Cancer Pain, sponsored by Johnson & Johnson Taiwan Ltd. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-12.
Sponsored by Johnson & Johnson Taiwan Ltd · Phase 3, Interventional, and Treatment
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.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's enrollment of 2 is below the median of 60 across 254 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Johnson & Johnson Taiwan Ltd is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Hydromprphone Hydrochloride (HCl) OROS
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.
Drug: Morphine Sustain Release (SR)
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.
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.
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
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
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
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
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
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
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
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
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
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
| Milestone | Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | Morphine Sustain Release (SR) |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
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).
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
The requirement of breakthrough pain medication will be recorded by participants. Morphine HCl, 10 mg, will be used as rescue medication for breakthrough pain.
No measurements were reported for this outcome.
Mean total daily dose of study medication taken during study will be recorded by participants.
No measurements were reported for this outcome.
Collected over Baseline up to Day 28. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | — | 0/1 (0%) | 1/1 (100%) |
| Morphine Sustain Release (SR) | — | 0/1 (0%) | 0/1 (0%) |
| Event | Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | Morphine Sustain Release (SR) |
|---|---|---|
| Oedema peripheralGeneral disorders | 1/1 | 0/1 |
| AnaemiaBlood and lymphatic system disorders | 1/1 | 0/1 |
| Chest discomfortGastrointestinal disorders | 1/1 | 0/1 |
| Abdominal distensionGastrointestinal disorders | 1/1 | 0/1 |
| Age, Customized(Participants) | Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | Morphine Sustain Release (SR) | Total |
|---|---|---|---|
| >=18 to <=40 years | 0 | 1 | 1 |
| >=41 to <=60 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) | Morphine Sustain Release (SR) | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 1 | 0 | 1 |
No study locations are listed for this record.
This study is terminated, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Taiwan Ltd