Chronic PainPhase 4TRANSITNCT03876158
Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)
A Phase 4 study testing Prometra II Programmable Pump system(Flowonix Medical) in people with Chronic Pain and Intractable Pain, run by Rush University Medical Center at 1 site in United States.
Trial summary
Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS). Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Chronic Pain, Intractable Pain, Back Pain
- What is being tested?
- Prometra II Programmable Pump system(Flowonix Medical)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2019to Jun 2022
- Phase
- Phase 4
- 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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be male or female between the ages of 22 and 85 years
- Be capable of giving informed consent and completing assessments required by the study
- Have pain intensity of greater than 5 out of 10 as measured by VAS
- Have an active existing peristaltic intrathecal drug delivery system
- Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant
- Be an appropriate candidate for surgery
- Be able to comply with required study visits and assessments including English proficiency
Who cannot join
- Have a significant pain disorder not intended to be treated with the test device or comparator
- Be terminally ill and/or have a life expectancy of less than 6 months
- Be a pregnant/lactating woman or a woman of child-bearing potential
- Have a systemic or local infection (contraindicated for pump implantation)
- Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
- Have an underlying condition increasing susceptibility to infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center Pain Center
Chicago, Illinois, 60612
About this study
Official title: Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center, Cross-Over Study (TRANSIT)
Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).
Read the detailed description
This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used.
This study will compare the historical pain medication dose and pain scores using the peristaltic pump at baseline as well as from the last pump refill visit prior to explant to the prospective pain medication dose and pain scores using the valve-gated pump and collected at refill visits 1, 2 and 3 after valve-gated pump implant (but not exceed 12 months).
- Conditions
- Chronic Pain, Intractable Pain, Back Pain
- Being tested
- Prometra II Programmable Pump system(Flowonix Medical)
- Medical subject headings
- Chronic Pain, Pain, Intractable, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prometra II Programmable Pump system(Flowonix Medical)Device
Also called Prior peristaltic Synchromed II pump
This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump
| Study group | Role | What they receive |
|---|---|---|
| Prometra® Programmable Pump | Active comparator | Pain scores and drug doses will be prospectively collected for valve-gated Prometra® Programmable Pump system(Flowonix Medical)' at (refill #1, refill #2, refill #3) and will be compared to retrospectively collected pain (VAS) scores and drug doses from the last refill prior to peristaltic pump explant. Receives: Device: Prometra II Programmable Pump system(Flowonix Medical) |
| Prior records for peristaltic pump | Other | Prior pain scores and drug doses from the patients who need a new valve gated pump will be recorded and used for comparison after it is changed. Receives: Device: Prometra II Programmable Pump system(Flowonix Medical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced pain medication through Prometra Implantable Pump System
Total consumption of Pain medication both oral and intra thecal would also be recorded to show change in pain medication.
Measured: 12 months from Implant
Secondary outcomes (1)
Change in pain score: Visual Analog Scale for Pain
Visual Analog Scale for Pain is being used assess the pain throughout the 12 month which shows No pain at one end to Pain as bad as it could be at other end.
Measured: 12 months from Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study startOct 2019 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: The study will not be conducted by Dr Lubenow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Prior Peristaltic Synchromed II intrathecal pump's data prior to crossover to valve-gated Flowonix Prometra® II Programmable Pump is recorded to compare.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Flowonix Medical
- Responsible party
- Principal investigator, Timothy Lubenow, Rush University Medical Center
- Investigators
- Asokumar Buvanendran, MD, Study chair, Rush University Medical CenterTimothy R Lubenow, MD, Principal investigator, Rush University Medical CenterRobert McCarthy, D. Pharm, Study director, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876158
- Sponsor's protocol ID
- ORA# 19011103
- Acronym
- TRANSIT
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2019
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hayek SM, Deer TR, Pope JE, Panchal SJ, Patel VB. Intrathecal therapy for cancer and non-cancer pain. Pain Physician. 2011 May-Jun;14(3):219-48.
PubMed 21587327Hayek SM, Veizi E, Hanes M. Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device. Pain Med. 2016 Mar;17(3):561-571. doi: 10.1093/pm/pnv021. Epub 2015 Dec 14.
PubMed 26814257Konrad PE, Huffman JM, Stearns LM, Plunkett RJ, Grigsby EJ, Stromberg EK, Roediger MP, Wells MD, Weaver TW. Intrathecal Drug Delivery Systems (IDDS): The Implantable Systems Performance Registry (ISPR). Neuromodulation. 2016 Dec;19(8):848-856. doi: 10.1111/ner.12524. Epub 2016 Oct 12.
PubMed 27730704Tangen KM, Leval R, Mehta AI, Linninger AA. Computational and In Vitro Experimental Investigation of Intrathecal Drug Distribution: Parametric Study of the Effect of Injection Volume, Cerebrospinal Fluid Pulsatility, and Drug Uptake. Anesth Analg. 2017 May;124(5):1686-1696. doi: 10.1213/ANE.0000000000002011.
PubMed 28431428
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center, Cross-Over Study (TRANSIT)
- ClinicalTrials.gov ID
- NCT03876158
- Acronym / sponsor ID
- TRANSIT / ORA# 19011103
- Conditions
- Chronic Pain, Intractable Pain, Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study will not be conducted by Dr Lubenow
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Flowonix Medical
- Study start
- Oct 2019 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 15 Mar 2019 (actual)
- 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.
Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).
Detailed description
This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used.
This study will compare the historical pain medication dose and pain scores using the peristaltic pump at baseline as well as from the last pump refill visit prior to explant to the prospective pain medication dose and pain scores using the valve-gated pump and collected at refill visits 1, 2 and 3 after valve-gated pump implant (but not exceed 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prior Peristaltic Synchromed II intrathecal pump's data prior to crossover to valve-gated Flowonix Prometra® II Programmable Pump is recorded to compare.
| Arm | Type | Receives |
|---|---|---|
| Prometra® Programmable Pump | Active comparator | Device: Prometra II Programmable Pump system(Flowonix Medical)Pain scores and drug doses will be prospectively collected for valve-gated Prometra® Programmable Pump system(Flowonix Medical)' at (refill #1, refill #2, refill #3) and will be compared to retrospectively collected pain (VAS) scores and drug doses from the last refill prior to peristaltic pump explant. |
| Prior records for peristaltic pump | Other | Device: Prometra II Programmable Pump system(Flowonix Medical)Prior pain scores and drug doses from the patients who need a new valve gated pump will be recorded and used for comparison after it is changed. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be male or female between the ages of 22 and 85 years
- Be capable of giving informed consent and completing assessments required by the study
- Have pain intensity of greater than 5 out of 10 as measured by VAS
- Have an active existing peristaltic intrathecal drug delivery system
- Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant
Key exclusion criteria (6 listed)
- Have a significant pain disorder not intended to be treated with the test device or comparator
- Be terminally ill and/or have a life expectancy of less than 6 months
- Be a pregnant/lactating woman or a woman of child-bearing potential
- Have a systemic or local infection (contraindicated for pump implantation)
- Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
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 |
|---|---|---|
| Prometra II Programmable Pump system(Flowonix Medical)Also: Prior peristaltic Synchromed II pumpThis valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump | Device | Prior records for peristaltic pump, Prometra® Programmable Pump |
Primary outcome
Reduced pain medication through Prometra Implantable Pump System
Time frame: 12 months from Implant
Total consumption of Pain medication both oral and intra thecal would also be recorded to show change in pain medication.
1 secondary outcome
Change in pain score: Visual Analog Scale for Pain
Time frame: 12 months from Implant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Results publication: PubMed 21587327Hayek SM, Deer TR, Pope JE, Panchal SJ, Patel VB. Intrathecal therapy for cancer and non-cancer pain. Pain Physician. 2011 May-Jun;14(3):219-48.
- Results publication: PubMed 26814257Hayek SM, Veizi E, Hanes M. Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device. Pain Med. 2016 Mar;17(3):561-571. doi: 10.1093/pm/pnv021. Epub 2015 Dec 14.
- Results publication: PubMed 27730704Konrad PE, Huffman JM, Stearns LM, Plunkett RJ, Grigsby EJ, Stromberg EK, Roediger MP, Wells MD, Weaver TW. Intrathecal Drug Delivery Systems (IDDS): The Implantable Systems Performance Registry (ISPR). Neuromodulation. 2016 Dec;19(8):848-856. doi: 10.1111/ner.12524. Epub 2016 Oct 12.
- Results publication: PubMed 28431428Tangen KM, Leval R, Mehta AI, Linninger AA. Computational and In Vitro Experimental Investigation of Intrathecal Drug Distribution: Parametric Study of the Effect of Injection Volume, Cerebrospinal Fluid Pulsatility, and Drug Uptake. Anesth Analg. 2017 May;124(5):1686-1696. doi: 10.1213/ANE.0000000000002011.
- Individual participant dataSharing planned: No
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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.
Asokumar Buvanendran, MD study chair
Rush University Medical Center
Timothy R Lubenow, MD principal investigator
Rush University Medical Center
Robert McCarthy, D. Pharm study director
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prometra II Programmable Pump system(Flowonix Medical) in people with Chronic Pain and Intractable Pain, run by Rush University Medical Center at 1 site 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 6 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: withdrawn, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Reduced pain medication through Prometra Implantable Pump System (time frame: 12 months from Implant). 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 NCT03876158, which also lists 4 linked publications.
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 Mar 2020.