3 completed, 3 withdrawn, 2 unknown, 1 approved for marketing. 6 Not applicable, 1 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 6 | Completed 3, Unknown 2, Withdrawn 1 |
| Phase 3 | 1 | Withdrawn 1 |
| Phase 4 | 1 | Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) Prometra II Programmable Pump - Flowonix Medical - Injuries, Spinal Cord, CVA (Cerebrovascular Accident) | Not applicable | Unknown | Culicchia Neurological Clinic | 92 | 2020-09-24 | 2020-09-28 |
| Transitioning to a Valve -Gated Intrathecal Drug Delivery System Prometra II Programmable Pump system - Flowonix Medical - Pain, Pain, Chronic | Not applicable | Unknown | Bux, Anjum, MD | 120 | 2020-07-27 | 2021-07-07 |
| Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS) Prometra II Programmable Pump system(Flowonix Medical) - Chronic Pain, Intractable Pain | Phase 4 | Withdrawn | Rush University Medical Center | 2019-10-01 | 2020-03-12 | |
| Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population Flowonix Prometra® II Programmable Infusion System, Pain Medicine - Chronic Nonmalignant Pain, Pain, Intractable | Not applicable | Completed | Evolve Restorative Center | 73 | 2019-06-05 | 2022-05-18 |
| A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain Intrathecal Drug Delivery System, Conventional Medical Management - Pain Management, Cancer Pain | Not applicable | Withdrawn | Flowonix Medical | 2016-04-01 | 2019-02-15 | |
| Prometra Post-Approval Study Prometra Programmable Intrathecal Infusion Pump - Chronic Pain, Cancer Pain | Not applicable | Completed | Flowonix Medical | 400 | 2013-06-20 | 2023-10-18 |
| Continuous Intrathecal Baclofen Infusion for Chronic Spasticity Prometra Programmable Implantable Pump System - Spasticity | Phase 3 | Withdrawn | Flowonix Medical | 2010-01-01 | 2015-03-06 | |
| Prometra's Utilization in Mitigating Pain (PUMP) Infusion Pump (Prometra) - Intractable Pain | Not applicable | Completed | Flowonix Medical | 110 | 2007-01-01 | 2012-08-17 |
| Prometra's Utilization in Mitigating Pain II Prometra Programmable Pump - Intractable Pain, Back Pain | Approved for marketing | Flowonix Medical | 2012-03-05 |
Pain, Intractable (6) · Back Pain (4) · Chronic Pain (4) · Cancer Pain (2) · Cerebral Palsy (2) · Multiple Sclerosis (2) · Muscle Spasticity (2) · Pain (2) · Stroke (2) · Agnosia (1) · Brain Injuries (1) · Brain Injuries, Traumatic (1) · Nervous System Diseases (1) · Neurodegenerative Diseases (1) · Pancreatic Neoplasms (1)
Acetaminophen (1) · Infusion Pumps (1)
United States (7)
Andrea Toomer, MD (1) · Anjum Bux, MD (1) · Asokumar Buvanendran, MD (1) · Cory Brantley (1) · Daniel R Kloster, MD (1) · Jason E Pope, MD (1) · Robert Levy, MD, PhD (1) · Robert McCarthy, D. Pharm (1) · Timothy R Lubenow, MD (1)
PMID 12593613, PMID 17084128, PMID 21587327, PMID 26814257, PMID 27434197, PMID 27730704, PMID 28431428, PMID 3809245, PMID 8329801, PMID 9285459