Intrathecal injection of a single dose of Ziconotide (Prialt®) to evaluate the option of continuous administration via implanted pump. A Pilot Study - Ziconotide Bolus injections Study

Conditions: Severe, Chronic pain in patients who require intrathecal analgesia
MedDRA version: 101Level: LLTClassification code 10049475Term: Chronic pain

Registration Number: EUCTR2009-012928-89-GB

Lead Sponsor: South Tees NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures