Clinical Trials Register

Summary
EudraCT Number:	2010-024010-61
Sponsor's Protocol Code Number:	DRO/IV-ART-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2011-11-18
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

Spain - AEMPS

A.2

EudraCT number

2010-024010-61

A.3

Full title of the trial

Ensayo clínico de no inferioridad para evaluar la eficacia y seguridad de la combinación de Condroitín sulfato e Hidrocloruro de glucosamina frente a Celecoxib en pacientes afectos de artrosis de rodilla (Non-inferiority clinical trial on the efficacy and safety of chondroitin sulphate and glucosamine hydrochoryde versus Celecoxib in patients with knee ostoarthritis)

A.3.1

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

Clininical trial on the efficacy and safety of chondroitin sulphate and glucosamine hydrochoryde versus Celecoxib in patients with knee ostoarthritis

Ensayo clínico para evaluar la eficacia y seguridad de la combinación de Condroitín sulfato e Hidrocloruro de glucosamina frente a Celecoxib en pacientes afectos de artrosis de rodilla

A.3.2

Name or abbreviated title of the trial where available

MOVES

A.4.1

Sponsor's protocol code number

DRO/IV-ART-01

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	BIOIBÉRICA 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	BIOIBÉRICA S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	BIOIBÉRICA S.A.
B.5.2	Functional name of contact point	CLINICAL RESEARCH AREA
B.5.3	Address:
B.5.3.1	Street Address	PLAZA FRANCESC MACIÀ 7
B.5.3.2	Town/ city	BARCELONA
B.5.3.3	Post code	08029
B.5.3.4	Country	Spain
B.5.4	Telephone number	34934904908
B.5.5	Fax number	34934909711
B.5.6	E-mail	mherrero@bioiberica.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	DROGLICAN 200 mg/250 mg cápsulas duras
D.2.1.1.2	Name of the Marketing Authorisation holder	BIOIBERICA, S.A.
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.3.4	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	GLUCOSAMINA HIDROCLORURO
D.3.9.3	Other descriptive name	GLUCOSAMINE HYDROCHLORIDE
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	250
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CONDROITIN SULFATO
D.3.9.1	CAS number	24967-93-9
D.3.9.3	Other descriptive name	CHONDROITIN SULFATE
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	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	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	Yes
D.2.1.1.1	Trade name	CELEBREX 200 mg cápsulas duras
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER, S.A.
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.3.4	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	CELECOXIB
D.3.9.3	Other descriptive name	CELECOXIB
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	200
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

Artrosis de rodilla (Knee osteoarthritis)

E.1.1.1

Medical condition in easily understood language

Artrosis de rodilla (Knee osteoarthritis)

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	LLT
E.1.2	Classification code	10003416
E.1.2	Term	Arthrosis
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

demostrar que el tratamiento combinado con CS/HG tiene una eficacia similar al CE en la reducción del dolor desde el inicio hasta los 6 meses de tratamiento (subescala del dolor del índice WOMAC) en pacientes con artrosis de rodilla con dolor moderado a severoD

E.2.2

Secondary objectives of the trial

la comparación de otros criterios de valoración relacionados con síntomas y signos de artrosis de rodilla y de la seguridad y tolerabilidad en los dos grupos de tratamiento.

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

Recogida de muestras de suero para el análisis de biomarcadores relacionados con la inflamación de la articulación, la destrucción del cartílago y la formación de hueso

E.3

Principal inclusion criteria

- Diagnóstico de artrosis primaria de rodilla según los criterios del ACR
- Pacientes con artrosis en estadio radiológico II o III según Kellgren y Lawrence
- Pacientes con dolor de rodilla moderado a severo: puntuación en la subescala del dolor del índice WOMAC> 301 en la visita de inclusión

E.4

Principal exclusion criteria

- Reumatismos articulares concurrentes (antecedentes y/o presencia actual de signos) que pudieran dar lugar a una interpretación errónea de la evaluación de la eficacia en el dolor o que interfirieran en dicha evaluación, como condrocalcinosis, enfermedad de Paget de la extremidad ipsolateral en relación con la rodilla afectada, artritis reumatoide, osteonecrosis aséptica, gota, artritis séptica, ocronosis, acromegalia, hemocromatosis, enfermedad de Wilson, osteocondromatosis, espondiloartropatía seronegativa, enfermedad mixta del tejido conjuntivo, enfermedad vascular del colágeno, psoriasis, enfermedad inflamatoria intestinal
- Pacientes con antecedentes de infarto de miocardio o ictus, o que hayan experimentado dolor torácico relacionado con una cardiopatía, o que hayan padecido enfermedades cardíacas graves, tales como insuficiencia cardíaca congestiva
- Pacientes con enfermedades o procesos de importancia, tales como trastornos psicológicos o psiquiátricos o consumo de drogas que, en opinión del investigador, es probable que alteren la evolución de la artrosis o la capacidad del paciente para completar el estudio

E.5 End points

E.5.1

Primary end point(s)

- Cambio desde el inicio del estudio (reducción media) en la puntuación en la subescala del dolor del índice WOMAC

E.5.1.1

Timepoint(s) of evaluation of this end point

6 meses

E.5.2

Secondary end point(s)

- Cambio desde el inicio del estudio (reducción media) en la puntuación de las subescalas de la función física y de rigidez del índice WOMAC
- Cambio desde el inicio del estudio (reducción media) del dolor según la puntuación de la escala visual analógica (EVA) de Huskisson
- Conjunto de criterios de respuesta al tratamiento de la Osteoarthritis Research Society International (OARSI).
- Evaluación de la presencia o ausencia de inflamación y/o derrame articular.
- Consumo de medicación de rescate.
- Evaluación global de la actividad de la enfermedad por parte del paciente.
- Evaluación global de la actividad de la enfermedad por parte del investigador.
- Evaluación global de la respuesta al tratamiento por parte del paciente.
- Evaluación global de la respuesta al tratamiento por parte del investigador.
- Estado de salud según el cuestionario de calidad de vida EuroQoL-5D.

E.5.2.1

Timepoint(s) of evaluation of this end point

6 meses

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Última visita del último paciente incluido en el ensayo clínico

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

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.1.2.1

Number of subjects for this age range:

360

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

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

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

560

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)

No se tiene previsto ningún plan específico para el tratamiento de los pacientes diferente del tratamiento habitual en artrosis de rodilla

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

2011-07-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-05-11

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

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