Clinical Trials Register

Summary
EudraCT Number:	2011-002480-19
Sponsor's Protocol Code Number:	A0081275
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-11-17
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

Spain - AEMPS

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 (PROTOCOL A0081275)

Estudio de fase 3b, multicéntrico, doble ciego, aleatorizado, de pregabalina controlado con placebo y de diseño cruzado con dos grupos, en el tratamiento de la fibromialgia con tratamiento antidepresivo concomitante para la depresión comórbida.

A.3.1

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

In this fibromyalgia pain study in patients taking medication for depression, neither subjects nor investigators will know treatment assignments. The study is to determine if pregabalin demonstrates improvement compared to placebo (inactive substance)in improving pain associated with fibromyalgia. Subjects will be randomly assigned by chance(like the flip of a coin) to receive either pregabalin or placebo in one treatment period and then switch to the opposite for the second treatment period.

Estudio en sujetos con fibromialgia que toman medicación para la depresión. Ni los pacientes ni los investigadores conocen el tratamiento que se asignará. El objetivo es determinar si pregabalina es mejor que el placebo (una substancia inactiva) en la mejoría del dolor en la fibromialgia. Los sujetos serán asignados de forma aleatoria (como al lanzar una moneda) para recibir pregabalina o placebo en un período de tratamiento y a continuación cambiarán al otro tratamiento en el segundo período.

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, SLU
B.1.3.4	Country	Spain
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	0018007181021
B.5.5	Fax number	0013037391119
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	European Union
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.3.9.1	CAS number	148553-50-8
D.3.9.3	Other descriptive name	PREGABALIN
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	European Union
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.3.9.1	CAS number	148553-50-8
D.3.9.3	Other descriptive name	PREGABALIN
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	European Union
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.3.9.1	CAS number	148553-50-8
D.3.9.3	Other descriptive name	PREGABALIN
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.

Este estudio será realizado en sujetos con fibromialgia. Los sujetos estarán en tratamiento concomitante para la depresión comórbida.

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.

Dolor extendido y sensibilidad dolorosa en músculos, ligamentos y tendones; los pacientes tienen que estar tratados con medicación antidepresiva para la depresión.

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	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.

Evaluar la eficacia de la pregabalina en comparación con placebo en sujetos con fibromialgia y depresión comórbida que están recibiendo tratamiento con un ISRS o un IRSN estable principalmente para tratar la depresión.

E.2.2

Secondary objectives of the trial

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

Evaluar la seguridad y la tolerabilidad de la pregabalina en esta población.

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. Existencia de un documento de consentimiento informado, firmado y fechado personalmente, que indique que se ha informado al sujeto (o a su representante legal) de todos los aspectos pertinentes del estudio.
2. Sujetos que estén dispuestos a y sean capaces de cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio incluida la enseñanza del uso y la cumplimentación de los diarios del dolor y del sueño por medio del sistema interactivo de respuesta a la voz (SIRV).
3. Varones o mujeres de cualquier raza o grupo étnico de 18 años de edad o más.
4. Los varones o mujeres deben utilizar métodos anticonceptivos adecuados. Las mujeres no podrán estar embarazadas ni en período de lactancia, o deberán ser posmenopáusicas o bien estar esterilizadas por métodos quirúrgicos; las mujeres con capacidad de procrear deberán utilizar métodos anticonceptivos adecuados (como el método de barrera o un método hormonal); todas las mujeres deben tener una prueba de embarazo negativa confirmada en el período basal.
5. En la visita de selección (V1), los sujetos deben cumplir los criterios del ACR de 1990 de fibromialgia (es decir, dolor generalizado presente durante 3 meses o más y dolor en al menos en 11 de 18 puntos de dolor con la palpación específicos).
6. Diagnóstico documentado de depresión (por ejemplo, trastorno depresivo mayor, depresión no especificada o distimia) y tratamiento con una dosis estable de un ISRS o un IRSN aprobado para el tratamiento de la depresión durante al menos 3 meses (sin cambios en el tipo de medicación). Durante este período de 3 meses, los sujetos deberán haber estar tomando una dosis estable de ISRS o IRSN en los 2 últimos meses previos a la aleatorización (véase el apartado 5.6).
7. En las visitas de selección (V1) y aleatorización (V2), los sujetos deberán tener una puntuación ? 4 en la escala de valoración numérica del dolor (período de recuerdo de 1 semana).
8. En la visita de aleatorización (V2), se deberán haber cumplimentado satisfactoriamente al menos 4 diarios de dolor en los últimos 7 días, con una puntuación media de dolor ? 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. Ha fracasado en ellos el tratamiento con pregabalina por falta de eficacia en dosis terapéuticas ? 300 mg/d, presentan intolerancia a la pregabalina o a algún componente de la pregabalina o han participado en un ensayo clínico de pregabalina. Si el sujeto ha recibido pregabalina y se retiró por un motivo distinto de la falta de eficacia o la intolerancia, podrá participar en el estudio. No se permite el uso de pregabalina en los últimos 30 días (antes de V1).
2. Uso de medicamentos prohibidos para el dolor/sueño (por ejemplo, sedantes, hipnóticos, AINE, opiáceos, relajantes musculares) durante el estudio. Precisarán un lavado antes de la entrada en el estudio (véase el apartado 5.7).
3. Sujetos con depresión severa basada en: 1) una puntuación HADS en la categoría severa (>/= 15), ó0 2) en opinión del investigador, haría que el paciente no sea apto para la participación en este estudio.
4. Sujetos con dolor debido a otras enfermedades (como NPD o NPH) que pueda interferir en la evaluación o en la autoevaluación del dolor asociado a la fibromialgia.
5. Sujetos con trastornos osteomusculares inflamatorios generalizados, enfermedades reumáticas generalizadas distintas de la fibromialgia, infecciones activas, trastornos endocrinos no tratados o trastorno somatomorfo.
6. Sujetos con enfermedad cardiovascular, hematológica, autoinmunitaria, endocrina, renal, hepática, retiniana o gastrointestinal clínicamente inestable.
7. Sujetos que se considere que tienen riesgo de suicidio o de autolesionarse según el criterio del investigador o los detalles de una evaluación del riesgo (véase el apartado 7.2.6.3).
8. Sujetos con solicitudes de discapacidad en proceso de tramitación o que actualmente reciban compensación económica por fibromialgia o enfermedades asociadas.
9. Velocidad de sedimentación globular (VSG) > 40 mm/h o valores anormales de anticuerpos antinucleares anormal (título de ANA ? 1:160) o factor reumatoide (FR > 80 UI/ml).
10. Aclaramiento de creatinina (CLcr) estimado ? 60 ml/min (con la ecuación de Cockcroft-Gault). Si los sujetos presentan un aclaramiento de creatinina ? 60 ml/min según este método de selección, podrá determinarse su aclaramiento de creatinina, a criterio del investigador, con una muestra de orina de 24 horas en el laboratorio central. Si el aclaramiento de creatinina medido en la orina de 24 horas es > 60 ml/min, no se excluirá al sujeto.
11. Participación en cualquier otro estudio clínico en los 30 días previos a la visita de selección y/o durante la participación en el estudio.
12. Electrocardiograma (ECG) de selección con anomalías clínicamente significativas.
13. El sujeto ha padecido una neoplasia maligna distinta de un carcinoma basocelular o un carcinoma in situ del cuello uterino en los últimos 5 años.
14. Sujetos que tienen dificultades para tragar comprimidos o que no toleran la medicación oral.
15. Recuento de plaquetas < 100 x 109/l; recuento de leucocitos < 2,5 x 109/l; recuento de neutrófilos < 1,5 x 109/l.
16. Abuso o dependencia de alcohol o de sustancias en el año anterior conforme al criterio del investigador.
17. Cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier anomalía analítica que aumente el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o interfiera en la interpretación de los resultados del estudio y, en opinión del investigador, impida la participación en el mismo.
18. Sujetos que sean miembros del personal del centro de investigación o empleados de Pfizer directamente implicados en la realización del ensayo.

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)).

Puntuación media del dolor del momento de evaluación, basada en la media de las 7 últimas puntuaciones diarias de la escala NRS-Dolor registradas en los diarios del dolor durante el tratamiento con la medicación del estudio en cada período de tratamiento (por ejemplo, diario del dolor [escala de valoración numérica de 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 to14.

El diario telefónico de dolor que utiliza un sistema interactivo de respuesta a la voz (SIRV) será completado de forma continua desde la semana 0 a la 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).

? Cuestionario sobre la repercusión de la fibromialgia (FIQ, Fibromyalgia Impact Questionnaire).
? Impresión global del cambio por el paciente (PGIC, Patient Global Impression of Change) al final del período 1 (V6).
? Proporción de sujetos con una reducción del dolor ? 30% y ? 50% según el diario del dolor.
? Cuestionario subjetivo sobre el sueño (diario; 5 preguntas).
? Escala hospitalaria de ansiedad y depresión (HADS, Hospital Anxiety and Depression Scale).
? Cuestionario EuroQol de 5 dimensiones (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, semanas 0, 6,14; PGIC, semanas 6, 14, proporción de sujetos con reducción del dolor y cuestionario subjetivo sobre el sueño del diario de dolor, usando los mismos métodos de análisis que los especificados para el parámetro principal de eficacia, semanas 6 y 14, HADS, semanas -1, 0, 6, 14, EQ-5D, semanas 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

Tolerabilidad

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

Italy

Mexico

Spain

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

Last Subject Last Visit

Última visita del último paciente.

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:

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

Según el protocolo.

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

2012-01-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-13

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

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