Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Chronic Pain

Pain

Pain, Intractable

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

All Drugs and Chemicals

Central Nervous System Depressants

Analgesics, Opioid

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.

Subjects randomized to the Conventional Medical Management group will continue with the standard of care procedures.

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).

Flowonix Prometra® II Programmable Infusion System

Injections, spinal cord stimulation, peripheral nerve stimulation, pain medication, etc.

Pain Medicine

Jason E Pope, MD

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:

1. To compare the change in pain intensity from baseline based on the Numeric Rating Scale \[NRS\] between subjects randomized to the IDDS group and subjects randomized to the CMM group.The comparison will be conducted at 3, 6, 9 and 12 months following enrollment. The evaluation at 6 months will be considered the primary time point for evaluation.

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.

1. Compare the subject reported PROMIS 29 between the IDDS group and CMM group. Individual subject scores recorded at baseline and months 3, 6, 9 and 12.
2. 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
3. Compare the number of other concurrent treatments performed on each subject between the IDDS group and CMM group. Individual subject counts recorded at months 3, 6, 9 and 12 will be compared.

Additional safety objective:

1. To characterize pain and device related adverse events for all subjects throughout the study through completion of 12 month follow-up or subject exit.

Subjects will be randomized in a 1:1 ratio to one of two groups

Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population

Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population (PROSPER)

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.

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.

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.

Compare the number of other concurrent treatments performed on each subject between the IDDS group and CMM group.

Spots Global Cancer Trial Database for flowonix prometra® ii programmable infusion system