Clinical Trials Register

Summary
EudraCT Number:	2011-002480-19
Sponsor's Protocol Code Number:	A0081275
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-07-23
Trial results	View 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

2011-002480-19

A.3

Full title of the trial

A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 2-WAY CROSSOVER STUDY OF PREGABALIN IN THE TREATMENT OF FIBROMYALGIA WITH CONCURRENT ANTIDEPRESSANT THERAPY FOR COMORBID DEPRESSION

STUDIO DI FASE 3B, MULTICENTRICO, IN DOPPIO CIECO, RANDOMIZZATO, CONTROLLATO CON PLACEBO, CON CROSSOVER A 2 VIE SU PREGABALIN NEL TRATTAMENTO DELLA FIBROMIALGIA CON TERAPIA ANTIDEPRESSIVA CONCOMITANTE PER DEPRESSIONE IN COMORBIDITA'

A.3.1

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

The study objective is to determine if pregabalin demonstrates improvement compared to placebo in improving pain associated with fibromyalgia. Neither subjects nor investigators will know treatment assignments. Subjects will be randomly assigned by chance to receive either pregabalin or placebo in one treatment period and then switch to the opposite for the second treatment period.

L’ obiettivo di questo studio e' valutare l’efficacia di Pregabalin rispetto al placebo (sostanza inattiva) in pazienti affetti da fibromialgia che assumono farmaci antidepressivi. Ne' gli sperimentatori ne' i soggetti saranno al corrente del trattamento assegnato. I soggetti saranno assegnati casualmente a trattamento con pregabalin o placebo, nel primo periodo e successivamente passeranno al trattamento opposto.

A.4.1

Sponsor's protocol code number

A0081275

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	PFIZER INC.
B.1.3.4	Country	United States
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	Pfizer Inc
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc
B.5.2	Functional name of contact point	Clinical Trials.gov Call Centre
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	001 800 7181021
B.5.5	Fax number	001 303 7391119
B.5.6	E-mail	clinicaltrials.govcallcenter@pfizer.com

D. IMP Identification
D.IMP: 1
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	Yes
D.2.1.1.1	Trade name	Lyrica
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	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	PREGABALIN
D.3.9.1	CAS number	148553-50-8
D.3.9.2	Current sponsor code	PD 144,723
D.3.9.4	EV Substance Code	SUB10023MIG
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	75
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Yes
D.2.1.1.1	Trade name	Lyrica
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	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	PREGABALIN
D.3.9.1	CAS number	148553-50-8
D.3.9.2	Current sponsor code	PD 144,723
D.3.9.4	EV Substance Code	SUB10023MIG
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	150
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Yes
D.2.1.1.1	Trade name	Lyrica
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	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	PREGABALIN
D.3.9.1	CAS number	148553-50-8
D.3.9.2	Current sponsor code	PD 144,723
D.3.9.4	EV Substance Code	SUB10023MIG
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	225
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

This study will be conducted in subjects with fibromyalgia. Subjects will also be on concurrent medication for comorbid depression

Lo studio verrà condotto s soggetti affetti da fibromialgia. I soggetti saranno anche in terapia per comorbidità con depressione

E.1.1.1

Medical condition in easily understood language

Widespread pain and tenderness in muscles, ligaments, and tendons, and patients must be treated with an antidepressant medication for depression.

dolori diffusi e debolezza muscolare, a legamenti e ai tendini. I pazienti devono anche essere in terapia con un farmaco antidepressivo per la depressione.

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	15.1
E.1.2	Level	PT
E.1.2	Classification code	10048439
E.1.2	Term	Fibromyalgia
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

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 pregabalin compared with placebo in subjects with fibromyalgia and comorbid depression currently on a stable SSRI or SNRI primarily being used to treat the depression.

Valutare l'efficacia di Pregabalin rispetto al placebo in soggetti con fibromialgia e in comorbidità per depressione, in terapia stabile con SSRI o SNRI, principalmente usata per trattare la depressione.

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of pregabalin in this population.

Valutare la sicurezza e tollerabilità di Pregabalin nella popolazione in studio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including the training and completion of the daily pain and sleep diaries using Interactive Voice Response System (IVRS). 3. Men or women of any race or ethnicity who are at least 18 years of age. 4. Men or women must use appropriate methods of contraception. Women must be nonpregnant and nonlactating,postmenopausal, or surgically sterilized; women of childbearing potential must use appropriate methods of contraception (including barrier or hormonal method); all women must have a confirmed negative serum pregnancy test at baseline. 5. At screening (V1), subjects must meet the 1990 ACR criteria for fibromyalgia (eg, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites). 6. Documented diagnosis of depression (eg, major depressive disorder, depression not otherwise specified (NOS), or dysthymia) and on stable dose of a single approved SSRI or SNRI agent for the treatment of depression for at least 3 months (with no change in medication type). During this 3 month period, subjects must be on a stable dose of SSRI or SNRI for the final 2 months prior to randomization. 7. At screening (V1) and randomization (V2), subjects must have a score of ≥4 on the Numeric Rating Scale for Pain (1-week recall period). 8. At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be ≥4.

1.Prova di documento di consenso informato firmato e datato personalmente, che indichi che il soggetto (o un suo rappresentante legalmente accettabile) è stato informato di tutti gli aspetti pertinenti dello studio. 2.Soggetti disponibili e in grado di rispettare le visite programmate, il piano di trattamento, gli esami di laboratorio e le altre procedure dello studio, tra cui apprendimento e completamento dei diari giornalieri relativi a dolore e sonno tramite sistema di risposta vocale interattiva (IVRS). 3.Uomini o donne appartenenti a qualunque razza o etnia che abbiano compiuto il 18° anno di età. 4.Uomini o donne che fanno uso di adeguati metodi contraccettivi. Le donne non devono essere gravide né allattare al seno, devono essere in post-menopausa o essere state sottoposte a sterilizzazione chirurgica; le donne fertili devono utilizzare adeguati metodi contraccettivi (tra cui metodo a barriera o ormonale); tutte le donne devono presentare un test di gravidanza sul siero negativo al basale. 5.In fase di screening (V1), i soggetti devono soddisfare i criteri 1990 ACR per la fibromialgia (es. dolore diffuso presente da almeno 3 mesi e dolore in almeno 11 dei 18 siti dolorabili specifici). 6. Diagnosi documentata di depressione (es. disturbo depressivo maggiore, depressione NAS o distimia) e dose stabile di un singolo agente SSRI o SNRI approvato per il trattamento della depressione da almeno 3 mesi (senza variazione del tipo di farmaco). Durante questo periodo di 3 mesi, i soggetti devono assumere una dose stabile di SSRI o SNRI per i 2 mesi finali prima della randomizzazione. 7.In fase di screening (V1) e di randomizzazione (V2), i soggetti devono avere un punteggio ≥4 nella scala numerica di valutazione (NRS) del dolore (periodo di richiamo di 1 settimana). 8.In fase di randomizzazione (V2), devono essere completati in maniera soddisfacente almeno 4 diari sul dolore negli ultimi 7 giorni e il punteggio medio del dolore deve essere ≥4.

E.4

Principal exclusion criteria

1. Have failed pregabalin treatment due to lack of efficacy at therapeutic doses of ≥300 mg daily, have intolerance to pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of efficacy or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted. 2. Use of prohibited pain/sleep medications, (eg, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry. 3. Subjects with severe depression based on either 1) a HADS score in the severe category (>/= 15), or 2) in the judgment of the investigator, would make the patient inappropriate for entry into this trial. 4. Subjects with pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia. 5. Subjects with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, untreated endocrine disorders, or somatoform disorder. 6. Subjects with any clinically unstable, cardiovascular, hematological, autoimmune, endocrine, renal, hepatic, retinal or gastrointestinal disease. 7. Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment. 8. Subjects with pending disability claims or currently receiving monetary compensation pertinent to the subject’s fibromyalgia or co-morbid diseases. 9. Erythrocyte sedimentation rate (ESR) >40 mm/h, abnormal antinuclear antibody (ANA ≥1:160 titer), or rheumatoid factor (RF >80 IU/mL). 10. Estimated creatinine clearance (CLcr) ≤60 mL/min (using Cockcroft-Gault equation). Subjects who have an estimated CLcr ≤60 mL/min by this screening method may have their CLcr measured, at the investigator’s discretion, with a 24-hour urine collection performed at the central laboratory. If this 24-hour urine CLcr is >60 mL/min, the subject is not excluded. 11. Participation in any clinical trial within the 30 days prior to screening and/or during study participation. 12. Screening electrocardiogram (ECG) with any clinically significant abnormality. 13. Have had a malignancy other than basal cell carcinoma or carcinoma in situ of the cervix within the past 5 years. 14. Subjects with difficulties swallowing capsules or unable to tolerate oral medication. 15. Platelet count <100x109/L; white blood cell (WBC) count <2.5x109/L; neutrophil count <1.5x109/L. 16. Alcohol or substance abuse or dependence within the previous year per investigator judgment. 17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 18. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

1. Non hanno risposto al trattamento con pregabalin a causa della mancanza di efficacia alle dosi terapeutiche di ≥300 mg al giorno, hanno mostrato intolleranza a pregabalin o a uno dei suoi ingredienti o hanno partecipato a una sperimentazione clinica sul pregabalin. Se il soggetto ha assunto pregabalin e ne ha interrotto l’uso per motivi diversi dalla mancanza di efficacia o intolleranza, sarà comunque considerato idoneo. L’uso di pregabalin negli ultimi 30 giorni (prima di V1) non è consentito. 2. Fanno uso di farmaci antidolorifici/sonniferi non consentiti (es. sedativi, ipnotici, FANS, oppiacei, miorilassanti) durante lo studio. Washout necessario prima dell’ingresso nello studio. 3. Soggetti con grave depressione basata su 1) punteggio HADS nella categoria di gravità (>/= 15) oppure 2) a discrezione dello sperimentatore, soggetti che non risultano adeguati alla partecipazione a questa sperimentazione. 4. Soggetti affetti da dolore dovuto ad altre condizioni (es. neuropatia periferica diabetica o neuropatia posterpetica) che possono confondere la valutazione o l’auto-valutazione del dolore associato alla fibromialgia. 5. Soggetti con patologie muscoloscheletriche infiammatorie diffuse, patologie reumatiche diffuse diverse da fibromialgia, infezioni attive, patologie endocrine non trattate o disturbi somatizzati. 6. Soggetti affetti da qualunque patologia clinicamente instabile, cardiovascolare, ematologica, autoimmune, endocrina, renale, epatica, retinica o gastrointestinale. 7. Qualunque soggetto considerato a rischio di suicidio o di auto-lesionismo in base al giudizio dello sperimentatore e/o ai dettagli di una valutazione dei rischi. 8. Soggetti con richieste di risarcimento in corso per disabilità o che stanno ricevendo compensi finanziari in relazione alla fibromialgia o alle patologie in comorbilità. 9. Velocità di eritrosedimentazione (VES) >40 mm/h, anticorpi antinucleo anomali (ANA ≥1:160 titolo) o fattore reumatoide (RF >80 IU/ml). 10. Clearance stimata della creatinina (CLcr) ≤60 ml/min (calcolata con l’equazione di Cockcroft-Gault). I soggetti con CLcr stimata ≤60 ml/min tramite questo metodo di screening possono essere sottoposti a misurazione della CLcr, a discrezione dello sperimentatore, con raccolta delle urine delle 24 ore presso il laboratorio centrale. Se la CLcr nelle urine delle 24 ore è >60 ml/min, il soggetto non viene escluso. 11. Partecipazione a una qualsiasi sperimentazione clinica nei 30 giorni precedenti alla visita di screening e/o durante la partecipazione allo studio. 12. Elettrocardiogramma (ECG) di screening che evidenzi una anomalia clinicamente significativa. 13. Soggetti con tumore maligno diverso dal carcinoma basocellulare o carcinoma in situ della cervice negli ultimi 5 anni. 14. Soggetti con difficoltà di deglutizione di capsule o incapaci di tollerare i farmaci orali. 15. Conta piastrinica <100x109/l; conta leucocitaria <2,5x109/l; conta dei neutrofili <1,5x109/l. 16. Abuso o dipendenza da alcool o sostanze nell’anno precedente a seconda del giudizio dello sperimentatore. 17. Altre condizioni mediche o psichiatriche gravi, acute o croniche, oppure valori di laboratorio fuori norma che potrebbero aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del prodotto sperimentale, o che potrebbero interferire con l’interpretazione dei risultati dello studio e che, secondo il giudizio dello sperimentatore, renderebbero il soggetto inadeguato alla partecipazione allo studio. 18. Soggetti appartenenti al personale del centro di sperimentazione o soggetti che sono dipendenti di Pfizer direttamente coinvolti nella conduzione della sperimentazione.

E.5 End points

E.5.1

Primary end point(s)

Endpoint mean pain score, based on the mean of the last 7 daily pain NRS scores from the daily pain diaries while receiving study medication in each treatment period (eg, daily pain diary (0-10 numeric rating scale)).

Punteggio medio del dolore endpoint, sulla base della media degli ultimi 7 punteggi NRS dai diari quotidiani del dolore, durante l’assunzione di farmaco in studio in ciascun periodo di trattamento (scala di valutazione numerica 0-10).

E.5.1.1

Timepoint(s) of evaluation of this end point

Daily pain IVRS diaries will be completed continuously from week 0 to 14

I diari quotidiani del dolore IVRS, saranno completati continuamente dalla settimana 0 alla 14.

E.5.2

Secondary end point(s)

Fibromyalgia Impact Questionnaire (FIQ); - Patient Global Impression of Change (PGIC) at the end of Period 1 (V6); - Proportions of subjects with ≥30% and ≥50% pain reduction based on daily pain diary; - Subjective Sleep Questionnaire (daily diary; 5 questions); - Hospital Anxiety and Depression Scale (HADS); and - EuroQoL 5-Dimensions (EQ-5D).

Fibromyalgia Impact Questionnaire (FIQ); - Patient Global Impression of Change (PGIC) alla fine del Periodo 1(V6); -Proporzione dei soggetti con riduzione del dolore ≥30% e ≥50% basata su i diari quotidiani sul dolore; - Questionario soggettivo sul sonno (diario giornaliero; 5 domande); - Hospital Anxiety and Depression Scale (HADS); - EuroQoL 5-Dimensions (EQ-5D).

E.5.2.1

Timepoint(s) of evaluation of this end point

FIQ, weeks 0, 6,14, PGIC, weeks 6, 14; daily pain diary proportions of subjects with pain reduction and Subjective Sleep Questionnaire, using the same analysis methods as specified for the primary efficacy endpoint, weeks 6 and 14, HADS, weeks -1, 0, 6, 14, EQ-5D, weeks 0, 6, 14.

FIQ, settimane 0, 6,14; PGIC, settimane 6, 14; proporzione di soggetti con riduzione del dolore e questionario sul sonno soggettivo,valutati usando lo stesso metodo analitico descritto per l’endpoint primario di efficacia, alle settimane 6 e 14; HADS, settimane -1, 0, 6, 14; EQ-5D, settimane 0, 6, 14.

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tollerabilità

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

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

Canada

Mexico

United States

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

LSLV

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

Number of subjects for this age range:

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:

275

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

300

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)

As per protocol

Come descritto sul protocollo

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

2012-02-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-03-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-07-22

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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