Cancer PainPhase 3NCT00803283
A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain
A Phase 3 study testing Hydromprphone Hydrochloride (HCl) OROS and Morphine Sustain Release (SR) in people with Cancer Pain, run by Johnson & Johnson Taiwan Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Hydromprphone Hydrochloride (HCl) OROS and Morphine Sustain Release (SR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Randomized, Open-Labeled, Multi-Center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Comparing With Morphine SR in Cancer Pain Patients
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.
Read the 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.
- Conditions
- Cancer Pain
- Being tested
- Hydromprphone Hydrochloride (HCl) OROS, Morphine Sustain Release (SR)
- Keywords
- Pain, Hydromorphone hydrochloride OROS, Morphine
- Medical subject headings
- Cancer Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromprphone Hydrochloride (HCl) OROSDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hydromprphone Hydrochloride (HCl) OROS |
| 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. Receives: Drug: Morphine Sustain Release (SR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Day 28
Secondary outcomes (8)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study director, Johnson & Johnson Taiwan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803283
- Sponsor's protocol ID
- CR015328
- Other IDs
- 42801PAI3008
- Status last verified
- Aug 2013
- First submitted
- 4 Dec 2008
- Last updated
- 12 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Labeled, Multi-Center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Comparing With Morphine SR in Cancer Pain Patients
- ClinicalTrials.gov ID
- NCT00803283
- Acronym / sponsor ID
- CR015328
- Conditions
- Cancer Pain
- Keywords
- Pain, Hydromorphone hydrochloride OROS, Morphine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 12 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydromprphone Hydrochloride (HCl) OROS | Experimental | Drug: Hydromprphone Hydrochloride (HCl) OROSParticipants 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. |
| Morphine Sustain Release (SR) | Active comparator | Drug: Morphine Sustain Release (SR)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromprphone Hydrochloride (HCl) OROSParticipants 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 |
| Morphine 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. | Drug | Morphine Sustain Release (SR) |
Primary outcome
Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14
Time frame: 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
Time frame: 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).
8 secondary outcomes
BPI Questionnaire Item 6 "How Much Pain You Have Right Now" Score
Time frame: Baseline, Day 14, Day 22 and Day 28
BPI Questionnaire Item "Pain Intensity" Score
Time frame: Baseline, Day 14, Day 22 and Day 28
BPI Questionnaire Item "Pain Relief" Score
Time frame: Baseline, Day 14, Day 22 and Day 28
BPI Questionnaire Item "Pain Interference" Score
Time frame: Baseline, Day 14, Day 22 and Day 28
Patient's Global Assessment on Effectiveness
Time frame: Day 14, Day 22 and Day 28
Investigator's Global Assessment on Effectiveness
Time frame: Day 14, Day 22 and Day 28
Number of Times the Pain Medication Required for Breakthrough Pain
Time frame: Baseline up to Day 28
Mean Total Daily Dose (TDD) of Study Medication
Time frame: Baseline up to day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Taiwan, Ltd. Clinical Trial study director
Johnson & Johnson Taiwan Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydromprphone Hydrochloride (HCl) OROS and Morphine Sustain Release (SR) in people with Cancer Pain, run by Johnson & Johnson Taiwan Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14 (time frame: Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.