Intractable PainPUMPNCT00817596
Prometra's Utilization in Mitigating Pain (PUMP)
A study testing Infusion Pump (Prometra) in people with Intractable Pain, run by Flowonix Medical at 3 sites in United States.
Trial summary
Clinical evaluation of the safety and efficacy of the Prometra Programmable Infusion Pump to accurately supply drug to the intrathecal space for the treatment of chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intractable Pain
- What is being tested?
- Infusion Pump (Prometra)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 110 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2007to Mar 2011
- Phase
- Interventional
- 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
- suffering from chronic pain
- 18 years of age or older
- life expectancy >6 months
- failure to respond to less invasive methods
- patient undergone successful morphine trial
- patient agrees with Protocol requirements
- patient considered good subject per clinician
Who cannot join
- Existing spinal problems that prevent treatment
- systemic infection
- patient is pregnant or breast feeding
- known allergy or sensitivity to materials
- coexisting medical condition that precludes pump usage
- subject requires MRI post procedure
- subject unwilling/unable to comply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pain Control Network
Louisville, Kentucky, 40205
Center for Pain Management
St Louis, Missouri, 63109
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Clinical evaluation of the safety and efficacy of the Prometra Programmable Infusion Pump to accurately supply drug to the intrathecal space for the treatment of chronic pain.
Read the detailed description
Chronic conditions of pain and spasticity are and have been major challenges to traditional medical treatment. Chronic pain and spasticity seriously reduce the quality of life and restrict normal daily activities for many people. The first line of defense is normally oral medications. However, a significant number of these patients require additional or alternative therapy due to the side effects of the oral medications or the intractable nature of the condition.
In 1979, Wand et. al. found that small amounts of morphine, when injected into the sub-arachnoid space, had significant affect in reducing pain. Since that time a number of drug products and infusion pumps have been developed to address this condition. The primary drug used for this purpose in preservative-free morphine sulfate solution which is delivered via an implanted intrathecal catheter. The Prometra Intrathecal Pump System is only the second programmable pump to be used in the treatment of chronic pain.
- Conditions
- Intractable Pain
- Being tested
- Infusion Pump (Prometra)
- Medical subject headings
- Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion Pump (Prometra)Device
Also called Prometra
Implantation of pump/catheter for infusion of morphine into the intrathecal space
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.
Accuracy was determined by calculation of the delivered to programmed drug volume (DP) ratio. The DP ratio was calculated as the ratio of delivered drug volume (the volumetrically determined delivered drug volume) to the programmed drug volume (the volume of drug that was programmed to be delivered) summed cumulatively for all fill/refills, including any unscheduled visits per patient.
The delivered drug volume over all (scheduled and unscheduled) valid fill/refill sessions was summed together per patient as the numerator and the programmed drug volume over all valid fill/refill sessions was summed together per patient as the denominator to provide a per-patient DP ratio.
Measured: 6 months - acute study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionMar 2011
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 Intractable 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flowonix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817596
- Sponsor's protocol ID
- G060192
- Acronym
- PUMP
- Status last verified
- Aug 2012
- First submitted
- 5 Jan 2009
- Last updated
- 17 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prometra's Utilization in Mitigating Pain (PUMP)
- ClinicalTrials.gov ID
- NCT00817596
- Acronym / sponsor ID
- PUMP / G060192
- Conditions
- Intractable Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Flowonix MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Posted 31 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical evaluation of the safety and efficacy of the Prometra Programmable Infusion Pump to accurately supply drug to the intrathecal space for the treatment of chronic pain.
Detailed description
Chronic conditions of pain and spasticity are and have been major challenges to traditional medical treatment. Chronic pain and spasticity seriously reduce the quality of life and restrict normal daily activities for many people. The first line of defense is normally oral medications. However, a significant number of these patients require additional or alternative therapy due to the side effects of the oral medications or the intractable nature of the condition.
In 1979, Wand et. al. found that small amounts of morphine, when injected into the sub-arachnoid space, had significant affect in reducing pain. Since that time a number of drug products and infusion pumps have been developed to address this condition. The primary drug used for this purpose in preservative-free morphine sulfate solution which is delivered via an implanted intrathecal catheter. The Prometra Intrathecal Pump System is only the second programmable pump to be used in the treatment of chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- suffering from chronic pain
- 18 years of age or older
- life expectancy >6 months
- failure to respond to less invasive methods
- patient undergone successful morphine trial
Key exclusion criteria (7 listed)
- Existing spinal problems that prevent treatment
- systemic infection
- patient is pregnant or breast feeding
- known allergy or sensitivity to materials
- coexisting medical condition that precludes pump usage
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 |
|---|---|---|
| Infusion Pump (Prometra)Also: PrometraImplantation of pump/catheter for infusion of morphine into the intrathecal space | Device | – |
Primary outcome
Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.
Time frame: 6 months - acute study
Accuracy was determined by calculation of the delivered to programmed drug volume (DP) ratio. The DP ratio was calculated as the ratio of delivered drug volume (the volumetrically determined delivered drug volume) to the programmed drug volume (the volume of drug that was programmed to be delivered) summed cumulatively for all fill/refills, including any unscheduled visits per patient. The delivered drug volume over all (scheduled and unscheduled) valid fill/refill sessions was summed together per patient as the numerator and the programmed drug volume over all valid fill/refill sessions was summed together per patient as the denominator to provide a per-patient DP ratio.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infusion Pump (Prometra) in people with Intractable Pain, run by Flowonix Medical at 3 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 7 inclusion and 7 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 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2012). 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?
Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed. (time frame: 6 months - acute study). 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 17 Aug 2012.