An interventional study of Prometra II Programmable Pump system - Flowonix Medical in Pain, Pain, Chronic and Pain, Intractable, sponsored by Bux, Anjum, MD. Status unknown at 8 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Bux, Anjum, MD · Not applicable, Interventional, and Treatment
Among 2,880 studies in Pain with a site in United States — 315 open to participants now, 394 under way, 24 of them phase 3. Pain · United States.
Among the 2,880 studies in Pain with a site in United States, this one is the 786th largest by planned enrollment of the 2,558 interventional ones that give a count, is one of 101 that started in 2020, is one of 1,241 with no phase, and was the 2,119th registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →315 of the 2,880 studies in Pain with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 21 Years and older · all sexes · healthy volunteers too.
The full table on the hub →2,880 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 249 · Phase 2 415 · Phase 3 374 · Phase 4 372
First in 1957; this study’s year is marked. 101 started in 2020.
Median enrollment 66 across the 2,558 interventional studies, 99 across the 299 observational. Of the 2,223 that completed or were terminated, 1,051 (47%) have results posted.
670 of 2,880 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Bux, Anjum, MD as lead sponsor.
Bux, Anjum, MD has 1 study filed under Pain — fewer than ten, so there is no comparison to draw.
172 of the studies in Pain with a site in United States that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07226258Phase 3Saol Therapeutics IncPhase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain | 2026-11-30 |
| NCT05964868Phase 3Jessyka LighthallEfficacy of Liposomal Bupivacaine Post Septorhinoplasty | 2026-12 |
| NCT07832552Phase 3Harrow IncA Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery | 2026-12 |
| NCT03823534Phase 3St. Louis UniversityPost-Op Pain Control for Prophylactic Intramedullary Nailing. | 2026-12-31 |
| NCT07276542Phase 3The Ketamine Research FoundationClinical Trial Exploring the Outpatient Treatment of Phantom Limb Pain With Ketamine Administration in a Six Month Study With a Minimum Remission Period of 7 Days Between Treatment Session. 25-30 Subjects With an Ongoing History of Significant PLP.--FDA and IRB Approved. | 2026-12-31 |
Among the 2,880 studies in Pain with a site in United States, from their registry updates:
This study is designed to explore if the valve-gated pump requires less drug to manage subject pain than the prior standard peristaltic pump in the same subject. The newly implanted valve-gated pump will be programmed to deliver a minimum dose reduction of 20% of the same medication that was delivered in the peristaltic pump prior to explant. The drug therapy will be evaluated and pain scores will be evaluated over time (3 refill cycles prospectively for the valve-gated pump and 6 months retrospectively for the peristaltic pump).
This study will employ a single-blind where study participants will not be told about the dose reduction of at least 20% when the valve-gated pump is implanted. A study participant has a significant potential to bias when informed they will get less drug with the new pump than they were receiving in the old pump this could subjectively affect pain scores as well. After valve-gated pump implant and dose reduction, the appropriate pain therapy will be provided to adequately address pain management in the opinion of the study investigator using standard of care processes and VAS scores.
Once subjects have been implanted with the valve-gated pump they will be started on a minimum 20% dose reduction (same medications and concentrations prior to explant). If at any time during the subjects' treatment it is determined by the investigator that the subjects' treatment dose needs to be increased, the dose can be increased in increments not to exceed 5% (no change to concentration) based on VAS scores at current and last visits.
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.
Subjects meeting all of the following criteria will be eligible for enrollment in the study:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from participating in the study:
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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
Pain scores and drug doses will be prospectively collected for valve-gated Prometra® Programmable Pump system(Flowonix Medical)' at (refills 1-3) and will be compared to 3 months retrospectively collected pain scores (VAS, ODI and Global Pain Scale Assessments) and drug doses prior to peristaltic pump explant.
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.
This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump
Also known as: Prior peristaltic Synchromed II pump
Reduced pain medication through Prometra Implantable Pump System
Total consumption of pain medications both oral and intrathecal is recorded to show changes.
Time frame: 12 months
Visual Analog Scale for Pain changes
Visual Analog Scale (VAS) for Pain is used assess pain throughout the study which shows No pain at low end to extreme Pain at high end.
Time frame: 12 months
Owestry Disability Index changes
Owestry Disability Index (ODI) are used to assess changes in lifestyle scores throughout the study which shows patient's level of function in daily living
Time frame: 12 months
Global Pain Scale Assessments
Global Pain Scale Assessments will be used to assess changes in scores throughout the study
Time frame: 12 months
Plan to share: No
Started Jul 2020 (actual). Primary completion is estimated for Apr 2023, 32 months after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 32 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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