PainPhase 3INFUSENCT00593281
INFUSE Morphine Study
A Phase 3 study testing Hylenex in people with Pain, run by Halozyme Therapeutics at 2 sites in United States.
Trial summary
Double-blind study comparing the pharmacokinetics, safety and tolerability of morphine administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX) and intravenously conducted in patients in a hospice care setting or through a palliative care medicine setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Hylenex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to Oct 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Males or females at least 18 years of age who are patients of San Diego Hospice \& Palliative Care or recruited through San Diego Hospice \& Palliative Care or the UCSD Center for Pain and Palliative Medicine.
- During the treatment days of the study, on opioid therapy other than morphine that is equivalent to ≥ 60 mg oral morphine per day and without unacceptable toxicity.
- Vital signs (BP, HR, RR) within normal range.
- Adequate venous access in both upper extremities.
- A negative pregnancy test (if female of child-bearing potential) within 7 days prior to first injection.
- Life expectancy ≥ ten days.
- Decision-making capacity.
- Signed, written IRB-approved informed consent. -
Who cannot join
- Known hypersensitivity or history of any toxicity to morphine.
- Morphine within the 4 days prior to the first study medication injection or anticipated to be receiving morphine during any of the treatment days in this study.
- Any contraindication to morphine.
- Known hypersensitivity to naloxone.
- Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX.
- Known allergy to bee or vespid venom.
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- Contraindication to IV heparin lock or known hypersensitivity to heparin.
- Edema, infection, or any other lower extremity or pelvic disorder that might affect subcutaneous absorption from the thigh.
- Hemoglobin < 10 g/dL.
- Presence of any other medical condition that would present an unacceptable safety risk to the patient.
- Participation in a study of any investigational drug or device within 30 days of enrollment in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCSD Thornton Hospital
San Diego, California, 92037
San Diego Hospice and Palliative Care
San Diego, California, 92103
About this study
Official title: INcreased Flow Utilizing Subcutaneously Enabled Morphine (INFUSE-Morphine) With and Without Human Recombinant Hyaluronidase (HYLENEX) and Intravenously
Double-blind study comparing the pharmacokinetics, safety and tolerability of morphine administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX) and intravenously conducted in patients in a hospice care setting or through a palliative care medicine setting. In this within-patient controlled study, each eligible study patient receives a single injection by each of the three methods of morphine administration, sequentially on three consecutive days, according to the order specified by a randomization schedule.
Each of the three injections consists of 5 mg of morphine (1.0 mL of 5 mg/mL solution). The HYLENEX injection will be 1 mL of 150 units. Although the IV administration will not be blinded, the two SC injections will be double-blinded, using the same volume of normal saline (0.9% sodium chloride) placebo (1.0 mL) as HYLENEX.
- Conditions
- Pain
- Being tested
- Hylenex
- Keywords
- Hyaluronidase, Hylenex, subcutaneous, morphine, absorption, bioavailability, PK study of morphine in patients with pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HylenexDrug
Add Hylenex to SC injection of Morphine
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | IV Morphine |
| 2 | Experimental | SC Morphine with Hylenex Receives: Drug: Hylenex |
| 3 | Active comparator | SC Morphine with Saline Receives: Drug: Hylenex |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenously
Measured: 29 days
Secondary outcomes (1)
Compare the safety and tolerability of these three methods of injections of morphine
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJan 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halozyme Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jay Thomas, M.D., Principal investigator, San Diego HospiceMark S Wallace, M.D., Principal investigator, UCSD Thornton Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593281
- Sponsor's protocol ID
- HZ2-05-06
- Other IDs
- 05-015-MI (Hospice #)
- Acronym
- INFUSE
- Status last verified
- Jan 2008
- First submitted
- 2 Jan 2008
- Last updated
- 14 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomas JR, Wallace MS, Yocum RC, Vaughn DE, Haller MF, Flament J. The INFUSE-Morphine study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneously administered morphine in patients with advanced illness. J Pain Symptom Manage. 2009 Nov;38(5):663-72. doi: 10.1016/j.jpainsymman.2009.03.009. Epub 2009 Oct 12.
PubMed 19819665
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INcreased Flow Utilizing Subcutaneously Enabled Morphine (INFUSE-Morphine) With and Without Human Recombinant Hyaluronidase (HYLENEX) and Intravenously
- ClinicalTrials.gov ID
- NCT00593281
- Acronym / sponsor ID
- INFUSE / HZ2-05-06
- Conditions
- Pain
- Keywords
- Hyaluronidase, Hylenex, subcutaneous, morphine, absorption, bioavailability, PK study of morphine in patients with pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Halozyme TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind study comparing the pharmacokinetics, safety and tolerability of morphine administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX) and intravenously conducted in patients in a hospice care setting or through a palliative care medicine setting. In this within-patient controlled study, each eligible study patient receives a single injection by each of the three methods of morphine administration, sequentially on three consecutive days, according to the order specified by a randomization schedule.
Each of the three injections consists of 5 mg of morphine (1.0 mL of 5 mg/mL solution). The HYLENEX injection will be 1 mL of 150 units. Although the IV administration will not be blinded, the two SC injections will be double-blinded, using the same volume of normal saline (0.9% sodium chloride) placebo (1.0 mL) as HYLENEX.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –IV Morphine |
| 2 | Experimental | Drug: HylenexSC Morphine with Hylenex |
| 3 | Active comparator | Drug: HylenexSC Morphine with Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females at least 18 years of age who are patients of San Diego Hospice \& Palliative Care or recruited through San Diego Hospice \& Palliative Care or the UCSD Center for Pain and Palliative Medicine.
- During the treatment days of the study, on opioid therapy other than morphine that is equivalent to ≥ 60 mg oral morphine per day and without unacceptable toxicity.
- Vital signs (BP, HR, RR) within normal range.
- Adequate venous access in both upper extremities.
- A negative pregnancy test (if female of child-bearing potential) within 7 days prior to first injection.
Key exclusion criteria (11 listed)
- Known hypersensitivity or history of any toxicity to morphine.
- Morphine within the 4 days prior to the first study medication injection or anticipated to be receiving morphine during any of the treatment days in this study.
- Any contraindication to morphine.
- Known hypersensitivity to naloxone.
- Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX.
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 |
|---|---|---|
| HylenexAdd Hylenex to SC injection of Morphine | Drug | 2, 3 |
Primary outcome
• Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenously
Time frame: 29 days
1 secondary outcome
Compare the safety and tolerability of these three methods of injections of morphine
Time frame: 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2008.
- Derived from this study: PubMed 19819665Thomas JR, Wallace MS, Yocum RC, Vaughn DE, Haller MF, Flament J. The INFUSE-Morphine study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneously administered morphine in patients with advanced illness. J Pain Symptom Manage. 2009 Nov;38(5):663-72. doi: 10.1016/j.jpainsymman.2009.03.009. Epub 2009 Oct 12.
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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.
Jay Thomas, M.D. principal investigator
San Diego Hospice
Mark S Wallace, M.D. principal investigator
UCSD Thornton Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hylenex in people with Pain, run by Halozyme Therapeutics at 2 sites in United States.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 14 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
• Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenously (time frame: 29 days). 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 NCT00593281, which also lists 1 linked publication.
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 14 Jan 2008.