E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Severe, Chronic pain in patients who require intrathecal analgesia |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 101 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049475 |
E.1.2 | Term | Chronic pain |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Is bolus administration of ziconotide a feasible method of predicting response to long term intrathecal administration via Implanted Intrathecal Drug Delivery Device (ITDD) |
|
E.2.2 | Secondary objectives of the trial |
Is the suggested dosage scheme effective? Is the suggested dosage scheme Safe? |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
repeat injection of the same dose |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Repeat injections at the same dose |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of subject number 20 completed |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |