E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Painful Diabetic Peripheral Neuropathy |
neuropatia diabetica periferica dolorosa |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetic nerve pain |
Nevralgia diabetica |
|
E.1.1.2 | Therapeutic area | Health Care [N] - Population Characteristics [N01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012683 |
E.1.2 | Term | Diabetic peripheral neuropathy |
E.1.2 | System Organ Class | 10029205 - Nervous system 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 |
To assess the safety of repeat applications of QUTENZA administered over a period of 12 months in subjects with PDPN |
• Valutare la sicurezza di QUTENZA somministrato mediante applicazioni ripetute per un periodo di 12 mesi in pazienti affetti da NDP dolorosa |
|
E.2.2 | Secondary objectives of the trial |
To assess the efficacy of repeat applications of QUTENZA administered over a period of 12 months in subjects with PDPN |
• Valutare l’efficacia di QUTENZA somministrato mediante applicazioni ripetute per un periodo di 12 mesi in pazienti affetti da NDP dolorosa |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures 2. Male or female >18 years of age 3. Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes 4. Stable glycemic control for at least 6 months prior to screening visit 5. Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of >4 at the screening and the baseline visit |
1. Prima di essere sottoposto a qualsiasi procedura di studio (compresa la sospensione, ove applicabile, dei farmaci non consentiti) il paziente o un suo rappresentante legale dovranno firmare il Consenso informato scritto approvato dal Comitato Etico indipendente (IEC) e le dichiarazioni sulla privacy richieste dalle normative nazionali 2. Paziente di sesso maschile o femminile di età >18 anni 3. Diagnosi di polineuropatia sensomotoria distale simmetrica dolorosa di origine diabetica, 4. Controllo glicemico stabile per un periodo minimo di 6 mesi prima della Visita di Screening 5. Punteggio medio di >4 alla NPRS (Scala numerica per la valutazione del dolore) applicata alle ultime 24 ore prima della Visita di Screening e della Visita Basale |
|
E.4 | Principal exclusion criteria |
1. Primary pain associated with PDPN in the ankles or above 2. Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN 3. Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain 4. Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study. 5. Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients, EMLA ingredients or adhesives |
1. Il dolore principale associato alla NDP dolorosa è a carico delle caviglie o della zona superiore 2. Presenza di uno disturbo, in grado di interferire con la valutazione della NDP dolorosa o di impedire un’identificazione univoca della causa del dolore: 3. Dolore significativo (di intensità moderata o superiore) di eziologia diversa dalla NDP in grado di interferire con la valutazione del dolore provocato dalla NDP dolorosa 4. Al momento dell’arruolamento le pazienti di sesso femminile in età fertile dovranno risultare negative al test di gravidanza su siero o su urine e dovranno accettare di adottare un metodo anticoncezionale ad efficacia elevata durante il corso dello studio. 5. Ipersensibilità alla capsaicina (cioè al peperoncino o ai prodotti da banco [OTC] a base di capsaicina), a uno qualsiasi degli eccipienti di QUTENZA, agli ingredienti della crema EMLA o agli adesivi |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale from baseline to endpoint (discontinuation or End of Study [EoS] visit). |
• Variazione percentuale del punteggio complessivo relativo alla qualità della vita connessa alla salute (HRQOL), valutata mediante la specifica scala Norfolk, dal basale all’endpoint (Visita di Interruzione [ET] o di Fine Studio [EoS]). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
baseline to endpoint (discontinuation or end of study visit) |
Baseline all'endpoint (interruzione o fine dello studio) |
|
E.5.2 | Secondary end point(s) |
• Neurological function as assessed by the UENS and sensory testing • Tolerability of patch application by: - dermal assessment (0–7 point severity score on dermal assessment scale); and - ''pain now'' NPRS scores after patch application - rescue medication use on days 1 through 5 • Adverse events and serious adverse events (SAEs) • Vital signs (heart rate and blood pressure) associated with patch application • Laboratory analyses • Intensity of neuropathic pain using ''average pain'' NPRS scores (Question 5 of BPI-DN form) • BPI pain severity index and pain interference index • Patient Global Impression of Change (PGIC) • Generic HRQOL measured by European Quality of Life – 5 Dimensions (EQ- 5D) questionnaire. • Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire |
● Funzione neurologica valutata mediante scala UENS e test sensoriali ● Tollerabilità dell’applicazione del cerotto mediante: o valutazione dermatologica (scala con indice di gravità da 0 a 7); e o “dolore attuale” mediante scala NPRS dopo l’applicazione del cerotto o uso di farmaci di salvataggio dal giorno 1 al giorno 5 ● Eventi avversi (AE) ed eventi avversi gravi (SAE) ● Segni vitali (frequenza cardiaca e pressione ematica) associati all’applicazione del cerotto ● Analisi di laboratorio ● Intensità del dolore neuropatico valutato mediante punteggi della scala NPRS relativi al “dolore medio” (domanda 5 del BPI-DN) ● Indice di intensità e di interferenza del dolore al BPI ● Percezione complessiva della variazione del dolore (Patient Global Impression of Change - PGIC) ● HRQOL generica, misurata mediante Questionario europeo sulla qualità della vita a 5 dimensioni (EQ-5D). ● Soddisfazione per il trattamento valutata mediante questionario SAT (Autovalutazione del trattamento) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline to endpoint (discontinuation or end of study visit) |
Baseline all'endpoint (interruzione o fine dello studio) |
|
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 41 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Russian Federation |
Ukraine |
|
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 patient last visit |
LVLS |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 22 |
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 | 22 |
E.8.9.2 | In all countries concerned by the trial days | 0 |