Clinical Trials Register

Summary
EudraCT Number:	2009-010008-27
Sponsor's Protocol Code Number:	F1J-MC-HMGP
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:	2009-05-06
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

2009-010008-27

A.3

Full title of the trial

Duloxetine 60 mg Once Daily Versus Placebo in the Treatment of Patients with Osteoarthritis Knee Pain

Duloxetina 60 mg, Administrado una Vez al Día, Frente a Placebo en el Tratamiento de Pacientes con Dolor Artrósico de Rodilla

A.4.1

Sponsor's protocol code number

F1J-MC-HMGP

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Lilly S.A.
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	CYMBALTA 30 mg cápsulas duras gastrorresistentes
D.2.1.1.2	Name of the Marketing Authorisation holder	ELI LILLY NETHERLAND BV
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	CYMBALTA
D.3.4	Pharmaceutical form	Gastro-resistant capsule, hard
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	DULOXETINA HIDROCLORURO
D.3.9.3	Other descriptive name	DULOXETINA HIDROCLORURO
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	30
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	CYMBALTA 60 mg cápsulas duras gastrorresistentes
D.2.1.1.2	Name of the Marketing Authorisation holder	ELI LILLY NETHERLAND BV
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	CYMBALTA
D.3.4	Pharmaceutical form	Gastro-resistant capsule, hard
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	DULOXETINA HIDROCLORURO
D.3.9.3	Other descriptive name	DULOXETINA HIDROCLORURO
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	60
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Gastro-resistant capsule*
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

Dolor Artrosico de Rodilla

Osteoarthritis Knee Pain

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9
E.1.2	Level	LLT
E.1.2	Classification code	10031166
E.1.2	Term	Osteoarthritis knees

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

El objetivo principal de este estudio es evaluar la eficacia de duloxetina 60 mg, administrado una vez al día, en comparación con placebo, en la reducción de la intensidad del dolor, determinada por la puntuación media del dolor sufrido en 24 horas a partir del Cuestionario breve para la evaluación del dolor -versión corta modificada en pacientes con dolor artrósico de la rodilla, durante un periodo de tratamiento doble ciego de 13 semanas.

E.2.2

Secondary objectives of the trial

Objetivos secundarios de contención:
• Evaluar la mejoría que percibe el paciente (determinada por la puntuación obtenida en la escala sobre la Impresión Global de Mejoría de la enfermedad percibida por el Paciente), durante el periodo de tratamiento
• Evaluar el cambio observado en la función física del paciente durante el periodo de tratamiento de 13 semanas (determinado por la subescala de función física de las Universidades Western Ontario y McMasters [WOMAC]).

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Addendda 1 al protocolo F1J-MC-HMGP para el almacenamiento de muestras tituladoDuloxetina 60 mg, Administrado una Vez al Día, Frente a Placebo en el Tratamiento de Pacientes con Dolor Artrósico de Rodilla.

E.3

Principal inclusion criteria

Mujeres y varones ambulatorios de al menos 40 años de edad, que cumplan los criterios clínicos y radiológicos del Colegio Americano de Reumatología (ACR) para el diagnóstico de artrosis en la rodilla, que presenta dolor durante ≥ 14 días en cada uno de los 3 meses previos a la inclusión en el estudio, así como una puntuación media del dolor en el cuestionario BPI mayor o igual a 4, tanto en la Visita 1 como en la Visita 2.Mujeres y varones ambulatorios de al menos 40 años de edad, que cumplan los criterios clínicos y radiológicos del Colegio Americano de Reumatología (ACR) para el diagnóstico de artrosis en la rodilla, que presenta dolor durante ≥ 14 días en cada uno de los 3 meses previos a la inclusión en el estudio, así como una puntuación media del dolor en el cuestionario BPI mayor o igual a 4, tanto en la Visita 1 como en la Visita 2.

E.4

Principal exclusion criteria

•Exposición previa a duloxetina;
•Presentar trastorno depresivo mayor (TDM), según se determina mediante el módulo de depresión de la Mini Entrevista Neuropsiquiátrica Internacional (M.I.N.I.);
•Haber sido previamente diagnosticado de psicosis, trastorno bipolar o trastorno esquizoafectivo;
•Haberse sometido previamente a un análisis del líquido sinovial, en el que se haya observado un valor de leucocitos ≥2000 mm3, lo que constituye un indicio de un diagnóstico distinto al de artrosis;
•Presentar antecedentes de abuso o dependencia de sustancias dentro del último año, con excepción de la nicotina o la cafeína;
•Haber recibido hialuronato o esteroides por vía intraarticular o haberse sometido a lavado articular, u otros tratamientos invasivos de la rodilla, en el transcurso de los últimos 3 meses;
•Haberse sometido a una artroscopia en el último año o artroplastia en la rodilla afectada en cualquier momento;
•Tener previsto someterse a una intervención quirúrgica durante el transcurso del estudio en la articulación afectada;
•Pacientes no ambulatorios, o que requieran el uso de muletas o andadores;
•Pacientes que se consideren que presentan un alto riesgo de suicidio según la escala C-SSRS;
•Estar recibiendo medicación excluida, cuya administración no pueda discontinuarse en la Visita 1.
•Posibilidad de requerir durante el transcurso del estudio, según el criterio del investigador, el uso de analgésicos, incluidos, a título enunciativo pero no restrictivo, antiinflamatorios no esteroideos (AINEs), acetaminofen/paracetamol, analgésicos opioideos u otras medicaciones excluidas por el protocolo.

E.5 End points

E.5.1

Primary end point(s)

La medida principal de eficacia es la media del dolor en 24 h obtenida a partir del cuestionario breve para la evaluacion del dolor (BPI).

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

Yes

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

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

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)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

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

Information not present in EudraCT

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

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	30
F.4.2	For a multinational trial
F.4.2.1	In the EEA	120
F.4.2.2	In the whole clinical trial	422

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

2009-06-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-06-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-05-20

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