E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Failed Back Syndrome |
Failed Back Syndrome |
|
E.1.1.1 | Medical condition in easily understood language |
In patients undergoing surgery at the lumbar spine are created as a result of the insult mechanical, functional or iatrogenic, fibrotic outcomes that can cause pain. |
Nei soggetti sottoposti ad interventi chirurgici al rachide lombare si creano, a seguito dell'insulto meccanico, funzionale o iatrogeno, esiti fibrotici che possono essere causa di dolore. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10028395 |
E.1.2 | Term | Musculoskeletal and connective tissue disorders |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 |
The dual direct action: a) stone on the branches of fibrosis, b) radical scavenger on the production of free radicals explicated by the drug when applied locally, we expect will promote root decompression and debridement by a fibrous tissue resulting in significant reduction (and in some cases resolution) of pain and therefore a functional improvement |
La duplice azione diretta: a) litica sui tralci di fibrosi, b) radical scavenger sulla produzione dei radicali liberi esplicata dal farmaco quando applicato localmente, ci aspettiamo favorirà la decompressione radicolare ed uno sbrigliamento dai tessuti fibrosi con conseguente significativa riduzione (ed in alcuni casi risoluzione) della sintomatologia dolorosa ed quindi un miglioramento funzionale. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
presence of FBSS |
presenza di FBSS |
|
E.4 | Principal exclusion criteria |
the presence of infectious processes in place, or impairment of the coagulation cascade to the risk of local complications, and patients are pregnant (and therefore the patients of childbearing age will be made to sign an informed consent to undergo the procedure in which attests not pregnant, as is commonly done for X-rays). |
presenza in atto di processi infettivi, o alterata funzionalità della cascata della coagulazione per il rischio di complicanze locali, e pazienti in stato di gravidanza (pertanto alle pazienti in età fertile verrà fatto firmare un consenso informato per poter essere sottoposta alla procedura in cui attesta di non essere incinta, come comunemente effettuato per gli esami radiologici). |
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E.5 End points |
E.5.1 | Primary end point(s) |
reduced consumption of opioids and analgesics drugs. |
riduzione nel consumo di farmaci analgesici oppioidi |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pre-first procedure
48h post-first procedure
Pre-second procedure
48h post-second procedure
pre-third procedure 48h after the third procedure
1 week after the third procedure
1 month after the third procedure
3 months after the third procedure |
Pre-prima procedura
48h post-prima procedura
Pre-seconda procedura
48h post-seconda procedura
Pre- terza procedura
48h post-terza procedura
1 settimana post-terza procedura
1 mese post-terza procedura
3 mesi post-terza procedura |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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
|
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |