Severe, Chronic pain in patients who require intrathecal analgesia MedDRA version: 101 Level: LLT Classification code 10049475 Term: Chronic pain
Conditions
Interventions
Trade Name: Prialt®
Product Name: Prialt®
Product Code: 23726/38873/20/727
Pharmaceutical Form: Solution for infusion
Sponsors
South Tees NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-bedridden (ambulatory) patient. 2. Age range from 18-65 years of age 3. Patient suffering from chronic pains resistant to the usual treatments and for whom intrathecal administration of analgesics is envisaged 4. Failure of conventional medical management. 5. Patient capable of judgment, who is informed and able to understand the information regarding the drug and the mode of administration 6. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Refusal to participate in the study; 2. Incapable of using or understanding how to handle the equipment; VAS score 3. Systemic infection, deep or superficial infection of the lumbar area 4. Limited life expectancy and inability to attend 3 times on the surgical day unit 5. Contraindication for implantation of a pump for intrathecal drug administration 6. Allergy to ziconotide or any of the excipients in the ziconotide vial 7. Previous history of psychological disorders which in the investigators opinion would put the patient at risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is bolus administration of ziconotide a feasible method of predicting response to long term intrathecal administration via Implanted Intrathecal Drug Delivery Device (ITDD);Secondary Objective: Is the suggested dosage scheme effective? Is the suggested dosage scheme Safe?;Primary end point(s): Reduction in Visual analogue score for pain (this is a pilot study).Reduction by 30% would be considered clinically significant outcome. | — |
Countries
United Kingdom
Outcome results
None listed