Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
InSet Technologies |
---|---|
Information provided by: | InSet Technologies |
ClinicalTrials.gov Identifier: | NCT00866164 |
Intrathecal infusion pumps are increasingly used to deliver analgesics for chronic intractable pain. The PUMP II trial is designed to evaluate the ongoing safety and efficacy of the new Prometra® Programmable Pump System for intrathecal administration of morphine sulfate to treat chronic intractable pain.
Condition | Intervention |
---|---|
Intractable Pain Back Pain Leg Pain Arm Pain Trunk Pain |
Device: Prometra Programmable Pump |
Study Type: | Expanded Access |
Official Title: | Prometra's Utilization in Mitigating Pain II |
The development of fully implantable systems changed the dynamics and risks associated with intrathecal drug delivery. Pump reservoirs could be refilled with medication more infrequently (every 1-3 months), greatly reducing the risk of infection. Pumps were initially driven by the pressure differential of an injected gas, pushing drug at a fixed rate from an isolated chamber through an orifice of predetermined size. Later, mechanical pumps were developed that allowed for programmability of different infusion rates, and complex administration of infusions and preset boluses. These pumps have dominated the US market for long-term intrathecal drug delivery systems (IDDSs), and have expanded the range of conditions and patients that can be treated successfully.
Because IDDSs characteristically deliver low flow rates of drug to the intrathecal space (<1 mL/day), the reliability, durability, and accuracy of the pump are critical for the efficacy and safety of treatment. This continued access trial will assess the ongoing safety and efficacy of a new fully implanted IDDS, the Prometra Programmable Pump.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Patient is suffering from cancer pain requiring strong opioids (e.g., fentanyl, methadone, levorphanol, hydromorphone, oxymorphone, oxycodone)
OR Patient has chronic, non-malignant pain OR Patient needs an implantable pump system (pump AND catheter) replaced due to malfunction or battery depletion. Patient must have documented history of sufficient pain relief with intrathecal morphine sulfate infusion.
Exclusion Criteria:
Contact: Nuala Ronan | 973 426 9229 ext 19 | nronan@insetinc.com |
Responsible Party: | InSet Technologies, Inc. ( Nuala Ronan, Director Clinical Affairs ) |
Study ID Numbers: | G060192/S019 |
Study First Received: | March 18, 2009 |
Last Updated: | March 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00866164 History of Changes |
Health Authority: | United States: Food and Drug Administration |
back pain intractable pain implantable infusion pump morphine |
Pain, Intractable Morphine Signs and Symptoms |
Neurologic Manifestations Pain Back Pain |
Pain, Intractable Signs and Symptoms Nervous System Diseases |
Neurologic Manifestations Pain Back Pain |