An interventional study of Flowonix Prometra® II Programmable Infusion System and Pain Medicine in Chronic Nonmalignant Pain, Pain, Intractable and Pain, Chronic, sponsored by Evolve Restorative Center. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by Evolve Restorative Center · Not applicable, Interventional, and Other
This study is being conducted to compare intrathecal morphine using the commercially available intrathecal drug delivery systems (IDDS), and conventional medical management (CMM) in subjects with non-cancer, refractory chronic pain.
This study will evaluate the following objectives:
Primary objective:
Secondary objectives:
For each of the following secondary objectives, the comparisons between the IDDS group and CMM group will be made using the intra-subject change from baseline as the dependent variable.
Additional safety objective:
90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.
This study's enrollment of 73 is above the median of 60 across 64 interventional studies indexed under Pain, Intractable.
Browse Pain, Intractable studies →This is the only study on the registry with Evolve Restorative Center as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A potential subject who has any listed in the Prometra® II labeling or any contraindications of intrathecal agents employed in the United States within the PACC, will be excluded. All subjects meeting any of the following criteria will also be excluded from this study:
Subject has any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
At the Baseline Visit or prior to Randomization, a subject will be excluded from continued participation if the subject has:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to the Intrathecal Drug Delivery System group will be implanted with the Prometra System under sterile technique in accordance with the Instructions for Use. The pump will be filled at the time of implantation with the prescribed medication.
Device: Flowonix Prometra® II Programmable Infusion System
Subjects randomized to the Conventional Medical Management group will continue with the standard of care procedures.
Drug: Pain Medicine
The Flowonix Prometra® II Programmable Infusion System consists of an implanted infusion pump and catheter, and external components including a clinician programmer, refill and catheter access port kits, the PTC™(a subject operated controller).
Injections, spinal cord stimulation, peripheral nerve stimulation, pain medication, etc.
Also known as: Systemic opioid therapy
Compare the change in Numeric Pain Rating Scale between the IDDS group and the CMM group
The Numeric Pain Rating Scale (NPRS) is a 0-10 numeric pain rating scale (11 point scale), where a higher scores equates to more pain. The primary endpoint for this post-marketing study is the comparison of the NPRS between the IDDS group and the CMM group collected in the Study Diary at various time points.
Time frame: Comparisons will be done prior to baseline visit and at 3, 6, 9 and 12 month visits.
Compare the change in PROMIS 29 scores between the IDDS group and CMM group
Compare the subject reported Patient-Reported Outcomes Measurement Information System (PROMIS) 29 between the IDDS group and CMM group. PROMIS 29 assesses pain intensity using a 0-10 numeric rating scale (11 point scale), where a higher score equates to more pain. Other health domains are scored using a Likert scale, where higher scores represent more of the specific domain being measured. The other health domains that are scored are: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities.
Time frame: Individual subject scores recorded at baseline visit and at 3, 6, 9 and 12 month visits.
Comparison of the accrued cost of therapy for pain
Compare the accrued cost of therapy for pain control including those related to adverse events, ED visits, cost of medications between the IDDS group and CMM group.
Time frame: Cost of therapy will be obtained at 3, 6, 9 and 12 month visits.
Comparison of other concurrent treatments
Compare the number of other concurrent treatments performed on each subject between the IDDS group and CMM group.
Time frame: Individual subject counts recorded at 3, 6, 9 and 12 month visits will be compared.
Plan to share: No
Ran from Jun 2019 to primary completion in Apr 2022, 34 months.
Of 26 interventional studies with no phase under Pain, Intractable, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 34. This study's 34 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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