Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Texas Southwestern Medical Center
Screening (-7 days to Day 0) * Physical exam and medical history; * Vital signs; * Blood tests; * Pain measurements (6 daily pain questionnaires for 7 days prior to receiving study drug); * Urine tests; * Pregnancy test; * Electrocardiogram (EKG), a tracing of the electrical activity of the heart; * Collection of demographic information (age, sex, ethnic origin); Study Drug: SP-SAP will be administered via a spinal injection. Depending on when the subject is enrolled in the study, the dose of SP-SAP will be between 1 and 90 micrograms of SP-SAP Therapy: Subject will arrive at the UTSW Eugene McDermott Center for Pain Management 2 hours prior to treatment. The following will take place: * Physical exam; * Pain measurements (6 pain questionnaires); * EKG; * The subject will have a catheter inserted into their spine and will receive the study drug intrathecally (into their spine). The catheter will remain in their spine for 4 hours. Less than 1 tablespoon of spinal fluid will be collected for research purposes; and * They will remain in the University of Texas Southwestern Medical Center Hospital for 24 hours for observation as a precaution. Follow-Up will occur weekly for 8 weeks and then monthly for 4 months as needed. During these visits the following will take place: * Physical exam (including sensory and motor skills) and medical history; * Vital signs; * Two tablespoons of blood will be drawn from your arm by needle stick for blood tests; * Pain measurements (6 pain questionnaires); * Urine tests; and * Electrocardiogram (EKG), a tracing of the electrical activity of the heart. The subject will be asked to keep a diary to record any nausea and vomiting as well as a medication log to record the pain medications and dosage that they take between visits. Each visit will take approximately 2 hours to complete 4 Month Follow-Up Informational data on the level of pain, adverse events, and sensory and motor function will be collected for the remaining 4 months of the study or until time of death. This information may be collected via patient diary, office visit or telephone interview.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
