Clinical Trials Register

Summary
EudraCT Number:	2021-001629-38
Sponsor's Protocol Code Number:	KLG0121
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-10-18
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-001629-38

A.3

Full title of the trial

A phase 2, multicenter, randomized, double blind, active controlled, parallel group study assessing the analgesic effect and safety of two doses of DFL24412 in patients with chronic low back pain compared to Ketoprofen Lysine Salt (KLS).

Studio clinico di fase 2, multicentrico, randomizzato, doppio cieco, con controllo attivo, a gruppi paralleli, volto a valutare l’effetto analgesico e la sicurezza di due dosi di DFL24412 in pazienti con lombalgia cronica verso Ketoprofene Sale di Lisina (KLS).

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Phase 2 trial, conducted in more than one site, in which no one knows the treatment assigned to the patient to evaluate the effect against pain and the safety of of the study drug, DFL24412, respect a control drug (Ketoprofen Lysine Salt, in patient with chronic low back pain

Sperimentazione, di fase 2, fatta in più di un centro, in cui nessuno sa a quale trattamento è assegnato il paziente, per verificare l'effetto antidolorifico e la sicurezza del farmaco in studio, DFL24412 rispetto a un farmaco di controllo (Ketoprofene Sale di Lisina) in pazienti con lombalgia cronica

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

KLG0121

A.5.4

Other Identifiers

Name:

Number:

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	DOMPé FARMACEUTICI S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Dompè Farmaceutici S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dompè Farmaceutici S.p.A.
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Via Santa Lucia 6
B.5.3.2	Town/ city	Milan
B.5.3.3	Post code	20122
B.5.3.4	Country	Italy
B.5.4	Telephone number	0258383378
B.5.5	Fax number	0258383324
B.5.6	E-mail	giuseppe.terpolilli@dompe.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ketoprofene sale di lisina
D.3.2	Product code	[KLS]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ketoprofene sale di lisina
D.3.9.1	CAS number	22071-15-4
D.3.9.2	Current sponsor code	KLS
D.3.9.4	EV Substance Code	SUB02834MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	co-cristallo di ketoprofene, lisina e gabapentin
D.3.2	Product code	[DFL24412]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	KETOPROFENE SALE DI LISINA
D.3.9.1	CAS number	22071-15-4
D.3.9.2	Current sponsor code	KLS
D.3.9.4	EV Substance Code	SUB02834MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GABAPENTIN
D.3.9.1	CAS number	60142-96-3
D.3.9.2	Current sponsor code	GABA
D.3.9.4	EV Substance Code	SUB07857MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	17
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	co-cristallo di ketoprofene, lisina e gabapentin
D.3.2	Product code	[DFL24412]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	KETOPROFENE SALE DI LISINA
D.3.9.1	CAS number	22071-15-4
D.3.9.2	Current sponsor code	KLS
D.3.9.4	EV Substance Code	SUB02834MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GABAPENTIN
D.3.9.1	CAS number	60142-96-3
D.3.9.2	Current sponsor code	GABA
D.3.9.3	Other descriptive name	Gabapentin
D.3.9.4	EV Substance Code	SUB07857MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	34
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Low Back Pain

Lombalgia Cronica

E.1.1.1

Medical condition in easily understood language

Chronic Low Back Pain

Mal di schiena cronico

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10052430
E.1.2	Term	Chronic lumbago
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of DFL24412 80 mg-34 mg per os (p.o.) and DFL24412 40 mg-17 mg p.o. in chronic low back pain compared to KLS (80 mg) at week 2

Valutare l’efficacia di DFL24412 80 mg-34 mg per os (p.o.) e DFL24412 40 mg-17 mg p.o. nella lombalgia cronica, rispetto al KLS (80 mg) alla settimana 2.

E.2.2

Secondary objectives of the trial

• To further evaluate the analgesic efficacy of DFL24412 80 mg-34 mg and DFL24412 40 mg-17 mg in chronic low back pain compared to KLS 80 mg.
• To assess the efficacy of DFL24412 compared to KLS on neuropathic component in chronic low back pain.
• To assess the effect of DFL24412 compared to KLS on quality of life, Patient Global impression of Change and work and mental impact.

• Valutare ulteriormente l'efficacia analgesica di DFL24412 80 mg-34 mg e DFL24412 40 mg-17 mg nella lombalgia cronica rispetto a KLS 80 mg.
• Valutare l'efficacia di DFL24412 rispetto a KLS sulla componente neuropatica nella lombalgia cronica.
• Valutare l'effetto di DFL24412 rispetto a KLS sulla qualità della vita, sulla percezione globale del cambiamento da parte del paziente e sull’impatto mentale e sull’impatto sul lavoro.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provide written informed consent before the initiation of any study-specific procedures
2. Must be 18-65 years of age at the time of signing the Informed Consent Form (ICF)
3. Have a normal physical examination, vital signs, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal results that are judged not clinically significant by the PI and documented as such in the eCRF
4. Diagnosis of persistent nonspecific chronic low back pain (CLBP, pain localised below the costal margin and above the inferior gluteal folds with no known specific pathology, persisting for at least 3 months), with no substantial recent change in pain severity or clinical management
5. Documented nociceptive and neuropathic components (DN4 >/= 4 for neuropatic component)
6. Report at least moderate pain (NRS>/= 4) before randomization
7. If undergoing physical and/or exercise-based therapy for back pain, therapy must be stable at least three weeks prior to study and remain the same throughout study
8. If a female with childbearing potential, have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test; Women of childbearing age and potential must be willing to use highly effective contraception during the study and for 3 months after the last study treatment dose. Male patients and theirfemale partners of childbearing age and potential must be willing to use effective contraception during the study and for 3 months after the last study treatment dose.
9. Have a negative COVID-19 antigen rapid test or have received vaccination for COVID-19

1. Fornire il consenso informato scritto (ICF) prima dell'inizio di qualsiasi procedura specifica per lo studio
2. Età compresa tra 18 e 65 anni al momento della firma del modulo di consenso informato (ICF)
3. Avere un normale stato di salute generale, segni vitali nella norma, risultati dei test clinici di laboratorio e risultati dell'elettrocardiogramma (ECG) nella norma o risultati anormali che sono giudicati non clinicamente significativi dal PI e documentati come tali nell'eCRF
4. Diagnosi di lombalgia cronica persistente non specifica (CLBP, dolore localizzato sotto il margine costale e sopra le pieghe inferiori del gluteo senza una patologia specifica conosciuta, persistente da almeno 3 mesi), senza cambiamenti recenti sostanziali nella gravità del dolore o nella gestione clinica
5. Documentate componenti nocicettive e neuropatiche ( DN4>/= 4 per la componente neuropatica)
6. Segnalare un dolore almeno moderato (NRS >/= 4) prima della randomizzazione
7. Se sottoposto a terapia fisica e/o terapia basata su esercizi per il mal di schiena, la terapia deve essere stabile da almeno tre settimane prima dell’ inizio dello studio e rimanere la stessa durante tutto lo studio
8. Se si tratta di paziente donna in età fertile, il test di gravidanza per la ß-gonadotropina corionica umana (ß-hCG) deve risultare negativo. Le donne in età fertile devono essere disposte a utilizzare un metodo contraccettivo altamente efficace durante lo studio e per 3 mesi dopo l’assunzione dell'ultima dose del trattamento in studio. I pazienti di sesso maschile e le loro partner in età fertile devono essere disposti a utilizzare misure contraccettive efficaci durante lo studio e per 3 mesi dopo l’assunzione dell'ultima dose del trattamento in studio.
9. Avere un test rapido per l'antigene COVID-19 negativo o essere stato vaccinato per COVID-19

E.4

Principal exclusion criteria

1. History of major thoraco-abdominal or low back surgery in the last 3 months
2. CLBP due to malignancy, fibromyalgia,ochronosis, recent trauma, infection, juvenile scoliosis or congenital malformation
3. Previous diagnosis of psychosis, bipolar disorder, schizoaffective disorder, major depressive disorder or neurological disorder
4. CLPB management requiring opiod or surgery
5. Any concomitant use of antidepressants and/or anticonvulsants, opioids, nonsteroidal anti-inflammatory drugs, muscle relaxants, and/or any other prohibited medication during the trial or being anticipated by the investigator to be required
6. Any concurrent medical condition that, in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being
7. History of drug and/or alcohol abuse or dependence, excluding nicotine and caffeine
8. Have alanine aminotransferase or aspartate aminotransferase higher than 100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram per deciliter (mg/dL)
9. Have serum creatinine level higher than 1.6mg/dL or creatinine clearance <60, or had renal transplantation or receiving renal dialysis
10. Severe or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic diseases, symptomatic peripheral vascular disease, hemorrhagic diathesis, haemolytic anemia, systemic immune-mediated and rheumatologic disorders, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
11. History of bronchial asthma, peptic ulcer, gastrointestinal bleeding, ulceration or perforation
12. Crohn’s disease or ulcerative colitis
13. Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (antiHCV) or human immunodeficiency virus I and II antibodies (anti-HIV I/II)
14. History of intolerance or hypersensitivity to: ketoprofen lysine salt or other drugs of the same class, gabapentin, rescue medications, component of the formulation; any history of severe drug allergy or hypersensitivity
15. Female patients who meet the following criteria: Pregnant, breast-feeding, and/or planning to become pregnant and/or breast-feed during the study
16. Treatment with any investigational product (IP) during the study and within the 3 months (or at least 5 half-lives, whichever is longer) prior to Visit 1
17. Be an employee or a relative of an employee of the investigational study center
18. Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments
19. Unable or unlikely to comply with the study protocol, to fulfill eDiary and questionnaires appropriately or unsuitable for any other reason, as judged by the PI

1. Storia di chirurgia lombare o toraco-addominale maggiore negli ultimi 3 mesi
2. Lombalgia cronica dovuta a neoplasia, fibromialgia, ocronosi, trauma recente, infezione, scoliosi giovanile o malformazione congenita
3. Precedente diagnosi di psicosi, disturbo bipolare, disturbo schizoaffettivo, disturbo depressivo maggiore o disturbo neurologico ed utilizzo corrente di antidepressivi
4. Gestione del CLBP che richieda utilizzo di oppioidi o chirurgia
5. Qualsiasi uso concomitante di antidepressivi, anticonvulsivanti, oppioidi, farmaci antinfiammatori non steroidei, miorilassanti, e/o qualsiasi altro farmaco proibito durante lo studio, o di cui lo sperimentatore prevede che ne venga richiesto l’uso.
6. Qualsiasi condizione medica concomitante che, a giudizio del PI, potrebbe interferire con la conduzione dello studio, confondere l'interpretazione dei risultati dello studio o mettere in pericolo il benessere del paziente
7. Storia di abuso o dipendenza da droghe e / o alcol, escluse nicotina e caffeina
8. Avere alanina aminotransferasi o aspartato aminotransferasi superiore a 100 Unità internazionali per litro (UI / l) o bilirubina totale superiore a 1,6 milligrammi per decilitro (mg / dl)
9. Avere livelli di creatinina sierica superiori a 1,6 mg / dL o una clearance della creatinina <60, o aver subito trapianto renale o essere sottoposti a dialisi renale
10. Malattie cardiovascolari, epatiche, renali, metaboliche, respiratorie o ematologiche severe o instabili, malattia vascolare periferica sintomatica, diatesi emorragica, anemia emolitica, disordini sistemici immuno-mediati e reumatologici o altre condizioni mediche o psichiatriche che, a giudizio dello sperimentatore, comprometterebbero la partecipazione o potrebbero portare al ricovero durante il corso dello studio
11. Episodi di asma bronchiale, ulcera peptica e sanguinamento, ulcerazione o perforazione gastrointestinale
12. Morbo di Crohn o colite ulcerosa
13. Test positivo per l'antigene dell'epatite B (HBsAg), per l’anticorpo anti-epatite C (antiHCV) o per gli anticorpi del virus dell'immunodeficienza umana I e II (anti-HIV I / II)
14. Storia di intolleranza o ipersensibilità al ketoprofene sale di lisina o ad altri farmaci della stessa classe, al gabapentin, ai farmaci di emergenza, ai componente della formulazione o qualsiasi storia di grave allergia o ipersensibilità ai farmaci
15. Pazienti di sesso femminile che soddisfano i seguenti criteri: gravidanza, allattamento e / o pianificazione di una gravidanza e / o allattamento durante lo studio
16. Trattamento con qualsiasi prodotto sperimentale (IP) durante lo studio ed entro i 3 mesi (o almeno 5 emivite, a seconda di quale sia il periodo più lungo) prima della Visita 1
17. Dipendente o parente di un dipendente del centro di studio
18. Incapacità di parlare e comprendere la lingua locale a sufficienza per comprendere la natura dello studio, fornire il consenso informato scritto e consentire il completamento di tutte le valutazioni dello studio
19. Incapace o probabilmente incapace di rispettare il protocollo, di compilare il diario elettronico e i questionari in maniera appropriata o non idoneo per qualsiasi altra ragione, come giudicato dal PI

E.5 End points

E.5.1

Primary end point(s)

• Change From Baseline in Average Daily Low Back Pain (LBP) intensity as Measured by an 11-point Numeric Rating Scale (NRS) at Week 2

• Variazione rispetto alla visita basale dell’intensità media giornaliera della lombalgia (LBP), valutata con la scala numerica di valutazione (NRS) a 11 punti alla settimana 2

E.5.1.1

Timepoint(s) of evaluation of this end point

Time Frame: Baseline, Week 2

Periodo: visita basale, settimana 2

E.5.2

Secondary end point(s)

Change From Baseline in Average Daily Low Back Pain Intensity (LBP) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1; Change From Baseline in Average Daily Low Back Pain (LBP) Intensity as Measured by an 11-point Numeric Rating Scale (NRS) at the follow-up visit; Change from baseline in Neuropathic Pain Symptom Inventory (NPSI) score at week 2; Change from baseline in Douleur Neuropathique en 4 Questions (DN4) score at week 2; Number of Participants Withdrawn Due to Lack of Efficacy; Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2; Change from Baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 2; Patient Global Impression of Change (PGI-C) Score; Change From Baseline in European Quality of Life Questionnaire-5 Dimension-5 Level (EQ-5D-5L) to Week 2; Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 2; Number of rescue interventions; Change from baseline in Douleur Neuropathique en 4 Questions (DN4) score at the follow-up visit

Variazione rispetto alla visita basale dell'intensità media giornaliera della lombalgia (LBP), valutata con la scala numerica di valutazione (NRS) a 11 punti alla settimana 1; Variazione rispetto alla visita basale nel punteggio LBP come misurato secondo la scala numerica di valutazione (NRS) a 11 punti alla visita di follow up; Variazione rispetto alla visita basale nel punteggio dell’inventario dei sintomi del dolore neuropatico NPSI (Neuropathic Pain Symptom Inventory) alla settimana 2; Variazione rispetto alla visita basale nel punteggio della scala di valutazione del dolore neuropatico DN4 (Douleur Neuropatique en 4 Questions) alla settimana 2; Numero di partecipanti ritirati per mancanza di efficacia; Variazione rispetto alla visita basale nel punteggio totale valutato con il questionario sulla disabilità Roland-Morris (RMDQ) alla settimana 2; Variazione rispetto alla visita basale nel punteggio totale della scala dell'ansia e della depressione ospedaliera (HADS) alla settimana 2; Punteggio di impressione globale del cambiamento del paziente (PGI-C); Variazione rispetto al basale nel questionario europeo sulla qualità della vita (EQ-5D-5L) alla settimana 2; Variazione rispetto alla visita basale del punteggio nello strumento di valutazione per la produttività lavorativa e il deterioramento dell'attività (WPAI) alla settimana 2; Numero di interventi di emergenza; Variazione rispetto alla visita basale nel punteggio della scala di valutazione del dolore neuropatico DN4 (Douleur Neuropatique en 4 Questions) alla visita di follow up

E.5.2.1

Timepoint(s) of evaluation of this end point

Time Frame: Baseline, Week 1; Time Frame: Baseline, Day 28; Time Frame: Baseline, Week 2; Time Frame: Baseline, Week 2; Time Frame: Baseline, Week 2; Time Frame: Baseline, Week 2; Time Frame: Baseline, Week 2; Time Frame: Week 2; Time Frame: Baseline, Week 2; Time Frame: Baseline, Week 2; Time Frame: week 2; Time Frame: Baseline, Day 28

Periodo: visita basale, settimana 1; Periodo: visita basale, giorno 28; Periodo: visita basale, Settimana 2; Periodo: visita basale, Settimana 2; Periodo di tempo: visita basale, settimana 2; Periodo: visita basale, settimana 2; Periodo: visita basale, settimana 2; Periodo: settimana 2; Periodo: visita basale, settimana 2; Periodo: valore di riferimento, settimana 2; Periodo: settimana 2; Periodo: visita basale, giorno 28

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

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

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

140

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

150

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-08-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-15

P. End of Trial
P.	End of Trial Status	Ongoing

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