Clinical Trials Register

Summary
EudraCT Number:	2018-000138-37
Sponsor's Protocol Code Number:	FMLD-HUNGRIA-2-42_FIII
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:	2018-02-15
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

2018-000138-37

A.3

Full title of the trial

PHASE III CLINICAL TRIAL FOR THE EVALUATION OF THE EFFICACY AND SAFETY OF A PARACETAMOL + IBUPROFEN COMBINATION IN PATIENTS WITH PRIMARY DYSMENORRHOEA

Ensayo clínico en fase III para evaluar la eficacia analgésica y seguridad de una combinación de Paracetamol + Ibuprofeno en pacientes con dismenorrea primaria.

A.3.1

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

PHASE III CLINICAL TRIAL FOR THE EVALUATION OF THE EFFICACY AND SAFETY OF A PARACETAMOL + IBUPROFEN COMBINATION IN PATIENTS WITH mENSTRUAL PAIN

Ensayo clínico en fase III para evaluar la eficacia analgésica y seguridad de una combinación de Paracetamol + Ibuprofeno en pacientes con dolor menstrual

A.4.1

Sponsor's protocol code number

FMLD-HUNGRIA-2-42_FIII

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	Laboratorios Farmalíder 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	Laboratorios Farmalíder 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	Laboratorios Farmalíder S.A.
B.5.2	Functional name of contact point	Miriam Bellido
B.5.3	Address:
B.5.3.1	Street Address	calle la Granja 1 3C
B.5.3.2	Town/ city	Alcobendas/Madrid
B.5.3.3	Post code	28108
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034916 612 335
B.5.6	E-mail	miriambellido@farmalider.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	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	Ibuprofen/paracetamol 200/500 mg granules
D.3.4	Pharmaceutical form	Granules for oral solution
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	IBUPROFEN
D.3.9.1	CAS number	15687-27-1
D.3.9.4	EV Substance Code	SUB08098MIG
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Paracetamol
D.3.9.1	CAS number	103-90-2
D.3.9.3	Other descriptive name	PARACETAMOL
D.3.9.4	EV Substance Code	SUB09611MIG
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	500
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	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	Codramol 200 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	FARMALIDER, 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.3.1	Product name	Codramol 200 mg
D.3.4	Pharmaceutical form	Powder for oral suspension
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	IBUPROFEN
D.3.9.1	CAS number	15687-27-1
D.3.9.4	EV Substance Code	SUB08098MIG
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.IMP: 3
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	Gelocatil 500
D.2.1.1.2	Name of the Marketing Authorisation holder	Ferrer Internacional, 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.3.1	Product name	Gelocatil 500
D.3.4	Pharmaceutical form	Granules
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	PARACETAMOL
D.3.9.3	Other descriptive name	PARACETAMOL
D.3.9.4	EV Substance Code	SUB09611MIG
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	500
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	Granules
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

DYSMENORRHOEA

E.1.1.1

Medical condition in easily understood language

MENSTRUAL PAIN

DOLOR MENSTRUAL

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The principal objective will be the evaluation of the analgesic effect of the fixed dose combination of Ibuprofen 200 mg and Paracetamol 500 mg for oral administration compared with Paracetamol 500 mg and Ibuprofen 200 mg alone and placebo in patients with dysmenorrhoea with moderate to severe pain.

El objetivo principal consiste en evaluar la eficacia analgésica de la combinación a dosis fija de ibuprofeno 200 mg y paracetamol 500 mg, en administración oral, frente a ibuprofeno 200 mg y paracetamol 500 mg por separado y placebo, en pacientes con dismenorrea con dolor de moderado a intenso.

E.2.2

Secondary objectives of the trial

Evaluation of safety and tolerability of the Ibuprofen-Paracetamol formulation and the monocomponents will be the secondary objective of the study.

Como objetivo secundario se evaluará la seguridad y la tolerabilidad de la formulación Ibuprofeno‐Paracetamol y los monocomponentes.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Female subjects able to understand and sign the informed consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and the right to deny their collaboration at any time throughout the study
2) Females aged > 18 years.
3) Primary Dysmenorrhoea with moderate or severe pain, with pain score higher or equal than 50 mm in the Visual Assessment Scale (VAS ≥ 50 mm)
4) At least four menstrual painful periods in the last six months that has needed analgesic treatment.
5) Regular menstrual cycle (28 ± 7 days).
6) Clinical History, physical examination and laboratory results without clinically relevant alterations.
7) Women who commit to use a reliable method of contraception, in opinion of the investigators, throughout the study.
8) Who agree not to take other analgesic drug different from the study drugs or the rescue medication during the study (until 72 hours after the first study drug administration).

1) Mujeres capaces de comprender y firmar el consentimiento informado para participar en el estudio, tras haber recibido información verbal y por escrito a propósito de los objetivos, diseño y riesgos potenciales derivados de su participación en el estudio, así como que conozcan que puedan modificar su decisión en cualquier momento durante su participación en el estudio.
2) Mujeres de edad ≥ 18 años.
3) Dismenorrea primaria con dolor de moderado a intenso alcanzando una puntuación mayor o igual de 50 mm en la Escala Analógica Visual (EVA ≥50 mm)
4) Al menos 4 ciclos menstruales dolorosos en los 6 meses anteriores, que hayan requerido medicación analgésica.
5) Ciclos menstruales regulares (28 ± 7 días).
6) Historia Clínica, exploración física y resultados de los análisis de laboratorio sin alteraciones clínicas relevantes.
7) Comprometerse a utilizar, en opinión del investigador, un método de anticoncepción fiable y estar en disposición de continuar con ese método anticonceptivo durante todo el estudio.
8) Que acepten no tomar analgésicos a excepción de los que el protocolo define como medicación de rescate durante el período de tratamiento (hasta pasadas 72 horas tras la administración de la primera dosis de la medicación del estudio).

E.4

Principal exclusion criteria

1) History of allergy or hypersensitivity to the study drugs, including rescue medication or any other NSAID or their excipients.
2) History of bronchial asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic edema.
3) History of peptic ulcer, NSAID gastrointestinal adverse reactions, gastrointestinal bleeding or other active bleeding disorders.
4) Moderate or severe hepatic, renal or cardiac active diseases.
5) Active disorders of blood coagulation.
6) Uncontrolled Epilepsy.
7) Ulcerative colitis or Crohn´s disease.
8) History of drug or alcohol abuse or dependency. Alcohol dependency must be considered as a weekly alcohol consumption of more than 14 units or a daily consumption of more than 2 units (One unit corresponds to 125 mL wine, 200 mL beer or 25 mL spirits).
9) Patients unable to abstain of alcohol, psychotropic or sedative drugs (i.e. benzodiazepines) or other forbidden medicines (see below) at least 48 hours or five elimination half-lives before or 24 h alter drug study administration. Forbidden drugs are NSAIDs other than those of the study, anticoagulants, thrombolytics and platelet antiaggregants, corticoids, MAO inhibitors, antipsychotics, antiepileptic drugs, SSRI, tricyclic antidepressants, sulfamides, methotrexate and lithium.
10) Patients who have taken any analgesic, anti-inflammatory, antispasmodic or other treatment for dysmenorrhoea within six hours before study drug administration.
11) Participants in any clinical trial (with experimental drugs or experimental medical devices) within the 30 days before the screening process.
12) Pregnant or lactating women.
13) History of any medical condition which in the opinion of investigators, may constitute a risk for the patient, or modify the study results.
14) Subjects who cannot meet the requirements of the study or that in the opinion of the researchers cannot participate.

1) Antecedentes de alergia o hipersensibilidad a la medicación del estudio, la medicación de rescate o a cualquier otro antiinflamatorio no esteroideo (AINE), o a alguno de sus excipientes.
2) Antecedentes de asma, broncoespasmo, rinitis aguda, pólipos nasales, urticaria o edema
angioneurótico.
3) Antecedentes de úlcera péptica, trastornos gastrointestinales por AINE, hemorragia gastrointestinal u otras hemorragias activas.
4) Insuficiencia renal, hepática o cardiaca de moderada a grave.
5) Diátesis hemorrágica u otros trastornos de la coagulación.
6) Epilepsia no controlada.
7) Enfermedad de Crohn o colitis ulcerosa.
8) Historial de dependencia de drogas de abuso o alcohol. A efectos del estudio, la dependencia de alcohol se define de la siguiente manera: consumo semanal promedio >21 unidades (hombres) y >14 unidades (mujeres), o consu o diario promedio de >3 unidades (hombres) y >2 unidades (mujeres) (Una unidad corresponde a aprox. 125 ml de vino, 200 ml de cerveza, 25 ml de licores).
9) Pacientes incapaces de abstenerse de alcohol, drogas psicotrópicas o sedantes (es decir,
benzodiazepinas) u otros medicamentos prohibidos (ver a continuación) al menos 48 horas o cinco semividas de eliminación antes o 24 horas después de la administración del estudio de fármacos. Los fármacos prohibidos son los AINE distintos de los del estudio, anticoagulantes, trombolíticos y antiagregantes plaquetarios, corticoides, inhibidores de la MAO, antipsicóticos, antiepilépticos, ISRS, antidepresivos tricíclicos, sulfamidas, metotrexato y litio.
10) Pacientes que hayan recibido algún analgésico, antiinflamatorio, antiespasmódico u otro tratamiento para la dismenorrea en las 6 horas previas a tomar la medicación de estudio
11) Que hayan recibido un fármaco experimental o usado un dispositivo médico experimental en el plazo de los 30 días previos a la selección.
12) Mujeres embarazadas o en período de lactancia.
13) Antecedentes de cualquier enfermedad o trastorno que, a criterio del investigador, pudiera constituir un riesgo para la paciente o alterar los resultados del estudio.
14) Que no puedan cumplir con los requisitos del estudio o que en opinión del investigador no deben participar.

E.5 End points

E.5.1

Primary end point(s)

Main Efficacy Variable: The study main variable will be the pain relief observed 6 hours after beginning of treatment, evaluated as Pain Intensity difference (PID) VAS measured (0‐100 mm).

Variable Principal de eficacia: la variable principal del estudio será la disminución del dolor a las 6 h de inicio del tratamiento, medida
en términos de diferencia de intensidad del dolor (PID) según la puntuación de la EVA (0‐100mm).

E.5.1.1

Timepoint(s) of evaluation of this end point

6 hours

6 horas

E.5.2

Secondary end point(s)

Secondary Efficacy Variables: also will be analyzed:
• Total Pain Relief (TOTPAR) at TOTPAR0-6h, TOTPAR0-12h, TOTPAR0-24h, and the Sum of Pain Intensity Difference (SPID) at SPID0-6h, SPID0-12h, SPID0-24h
• Pain Relief at every time-point (hour) from 0 to 6 hours.
• Frequency of rescue medication use.
• Time to significant pain relief.
• Rate of responding patients.
• Patient global assessment.
Safety Variables:
Safety evaluation will include physical examination, including vital signs (BP, HR, BT), adverse events counting. Safety Follow-up visit will include results of laboratory test.

Variables de eficacia secundarias:
 Alivio total del dolor (TOTPAR) en TOTPAR0‐6h, TOTPAR0‐12h, TOTPAR0‐24h y la suma de las diferencias de la intensidad del dolor en, SPID0‐6h, SPID0‐12h, SPID0‐24h
. Alivio del dolor a todos los tiempos de evaluación del dolor (horas) comprendidos entre 0 y 6 horas
. Frecuencia de la utilización de la medicación de rescate.
. Tiempo hasta conseguir alivio significativo del dolor.
. Tasa de pacientes respondedores al tratamiento.
. Evaluación global del tratamiento por el paciente.

Variables de seguridad:
Las evaluaciones de seguridad incluirán una exploración física general, constantes vitales (presión arterial, frecuencia cardíaca, temperatura corpora) y la tasa de acontecimientos adversos. La visita de seguimiento de seguridad incluirá además las pruebas analíticas.

E.5.2.1

Timepoint(s) of evaluation of this end point

12h, 24h, 1 month, 1month +1 week

12 h, 24h, 1 mes, 1 mes + 1 semana

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)

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)

Yes

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

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

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 patient last visit

Ultima visita del ultimo 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

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:

480

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

480

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)

None

Ninguno

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

2018-04-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-03-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-02-06

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