IRB #: 110369
Study Title: “P100 – The Clinical Evaluation of the Implantable Pump System for Safety and Delivery Accuracy in Patients Requiring Intrathecal Administration of Morphine Sulfate for Chronic Pain”
Dr. Mark Wallace and his associates are conducting a research study for the Alfred Mann Foundation. The goal of this 12 month clinical research study is to learn if the investigational Implantable Pump System (IPS) can help improve the delivery of morphine into the spine given for pain relief. The safety of the IPS will also be studied. This is an investigational study. At this time, the pump and catheter are only being used in research and are not FDA approved or commercially available. The drug Morphine Sulfate in the form or Infumorph, is FDA approved for use in the spine. The study doctor will only use Infumorph during the study.
Subjects will be eligible to participate in the clinical trial if they meet the following Inclusion Criteria:
- Must be at least 21 years of age.
- Must have experienced chronic pain for at least 6 months.
- Not presently be on intrathecal therapy but must be considered a candidate for intrathecal analgesia by his pain specialist; or, a subject already on intrathecal therapy must be in need of a replacement intrathecal pump and catheter.
- Ineffective pain control with single or multiple systemic analgesic treatments (oral, rectal, IV or transdermal) or had intolerable side effects.
- Cancer pain requiring strong opioids or non-malignant pain with average Visual Analog Scale (VAS) score of >4/10.
Subjects will not be eligible for the clinical trial if they meet any of the following Exclusion Criteria:
- Female who is pregnant or is planning a pregnancy.
- Known central nervous system contraindication to intrathecal therapy, including but not limited to severe spinal canal stenosis or spinal cord compression
- Allergy to morphine sulfate, or for whom morphine sulfate is contraindicated.
- Life expectancy of less than 9 months.
- Exposure to high-current industrial equipment (i.e. electricians or electrical engineers) or regularly exposed to MRI equipment (i.e. MRI technicians, MRI engineers and MRI clinicians).
For more information, please contact:
Cindy Martin, Clinical Research Coordinator
Staff Research Associate III
University of California, San Diego Medical Center
Center for Pain Medicine
Tel. 858-657-7038 ext.77038