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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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

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 groups in NCT00803283
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.

Nov 2008Dec 2008

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Cancer Pain trials

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.

Detailed description

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

Results posted to the registry on 12 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)	1	1
Morphine Sustain Release (SR)	1	1

Primary outcome: Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14

Time frame: Day 14

Population analysed: 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 outcome: BPI Questionnaire Item 3 "Worst Pain" Score at Day 28

Time frame: Day 28

Population analysed: Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 28. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)	0 of 1 (0%)	1 of 1 (100%)	Not reported
Morphine Sustain Release (SR)	0 of 1 (0%)	0 of 1 (0%)	Not reported

Limitations and caveats (from the sponsor): This study had inadequate number of participants. 'The study was terminated early and the data for efficacy assessments were missing.

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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Recruiting
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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?

On the ClinicalTrials.gov record for NCT00803283.

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.