Clinical Trials Register

Summary
EudraCT Number:	2018-002929-36
Sponsor's Protocol Code Number:	TBFP2018
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:	2018-09-17
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

2018-002929-36

A.3

Full title of the trial

COMPARATIVE STUDY OF THE EFFICACY OF THE TREATMENT OF PLANTAR FASCITIS WITH INFILTRATION OF CORTICOIDS VS BOTULINIC TOXIN. ECOGRAPHIC FINDINGS

ESTUDIO COMPARATIVO DE LA EFICACIA DEL TRATAMIENTO DE LA FASCITIS PLANTAR CON INFILTRACIÓN DE CORTICOIDES VS TOXINA BOTULÍNICA. HALLAZGOS ECOGRAFICOS

A.3.1

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

EFFICACY OF CORTICOIDS VS BOTULINIC TOXIN IN THE TREATMENT OF PLANTAR FASCITIS

EFICACIA DE CORTICOIDES VS TOXINA BOTULÍNICA EN EL TRATAMIENTO DE LA FASCITIS PLANTAR

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

TBFP2018

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	Dra. Virginia Raquel Céspedes Nava
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	NA
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	Hospital Universitario Doce de Octubre
B.5.2	Functional name of contact point	Dra. Virginia Raquel Céspedes Nava
B.5.3	Address:
B.5.3.1	Street Address	Av. Córdoba, s/n
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28034
B.5.3.4	Country	Spain
B.5.6	E-mail	cespedesnvirginiar@gmail.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	Xeomin®
D.2.1.1.2	Name of the Marketing Authorisation holder	Merz Pharma España S.L.
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	IncobotulinumtoxinA
D.3.2	Product code	IncobotulinumtoxinA
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BOTULINUM TOXIN TYPE A
D.3.9.1	CAS number	93384-43-1
D.3.9.2	Current sponsor code	TBFP2018
D.3.9.3	Other descriptive name	BOTULINUM TOXIN TYPE A
D.3.9.4	EV Substance Code	SUB13117MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	TRIGON DEPOT®
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol - Myers Squibb, 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	Triamcinolona acetónido
D.3.2	Product code	Triamcinolona acetónido
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRIAMCINOLONE ACETONIDE
D.3.9.2	Current sponsor code	TBFP2018
D.3.9.4	EV Substance Code	SUB04936MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Plantar fasciitis

Fascitis plantar

E.1.1.1

Medical condition in easily understood language

Plantar fasciitis

Fascitis plantar

E.1.1.2

Therapeutic area

Body processes [G] - Physical Phenomena [G01]

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

To compare the efficacy of treatment with corticosteroids vs botulinum toxin in plantar fasciitis (EVA scale at 1 and 3 months after treatment).

Comparar la eficacia del tratamiento con corticoides vs toxina botulínica en la fascitis plantar (Escala EVA a 1 y 3 meses tras el tratamiento).

E.2.2

Secondary objectives of the trial

To compare the following parameters between both treatments:
-Efficacy of treatment with corticosteroids vs botulinum toxin in plantar fasciitis (EVA scale at 7-10 days and at 6 months after treatment).
-Quality of life (SF36)
-Consumption of analgesics
-Security and tolerability

Comparar los siguientes parámetros entre ambos tratamientos:
-Eficacia del tratamiento con corticoides vs toxina botulínica en la fascitis plantar (Escala EVA a los 7-10 días y a los 6 meses tras el tratamiento).
-Calidad de vida (SF36)
-Consumo de analgésicos
-Seguridad y tolerabilidad

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-EVA ≥ 6.
-Over 18 years.
-Being able to read and write in Spanish.
-Diagnosticated plantar fasciitis with clinical symptoms of 3 months or more in duration.
- Written informed consent of the patients

-EVA ≥ 6.
-Mayores de 18 años.
-Saber leer y escribir en español.
-Diagnosticadas de fascitis plantar con sintomatología clínica de 3 meses o más de duración.
-Consentimiento informado por escrito de los pacientes.

E.4

Principal exclusion criteria

-Patients who have suffered serious infectious processes or serious injuries to the feet in the last 6 months.
-Patients with serious systemic diseases.
-Patients with active oncological diseases.
-Patients in which the use of botulinum toxin or corticoids is contraindicated according to the respective technical data sheets.
-Pregnant or nursing patients.
-Patients who cannot answer the questionnaires properly.
-Previous treatment with botulinum toxin, in any of its preparations, without clinical response.
-Patients that have been infiltrated in the affected foot previously.
-Patients who have undergone surgery in the affected region in the 6 months prior to inclusion.
-Patients with bilateral plantar fasciitis.
-Patients anticoagulated.

-Pacientes que hayan sufrido procesos infecciosos graves o traumatismos graves en los pies en los últimos 6 meses.
-Pacientes con enfermedades sistémicas graves.
-Pacientes con enfermedades oncológicas activas.
-Pacientes en los que esté contraindicado el uso de toxina botulínica o corticoides según las respectivas fichas técnicas.
-Pacientes embarazadas o en periodo de lactancia.
-Pacientes que no puedan contestar adecuadamente los cuestionarios.
-Tratamiento previo con toxina botulínica, en cualquiera de sus preparaciones, sin respuesta clínica.
-Pacientes que han sido infiltrados en el pie afecto previamente.
-Pacientes que hayan sido sometidos a intervención quirúrgica en la región afecta en los 6 meses previos a la inclusión.
-Pacientes con fascitis plantar bilateral.
-Pacientes anticoagulados.

E.5 End points

E.5.1

Primary end point(s)

Pain: Variation in the EVA scale (0-10)

Dolor: Variación en la escala EVA (0-10)

E.5.1.1

Timepoint(s) of evaluation of this end point

At month and 3 months after treatment.

Al mes y a los 3 meses del tratamiento.

E.5.2

Secondary end point(s)

- Effect to other times different from the infiltration of drugs
- Quality of life: Questionnaire SF36
- Presence of ultrasound findings: variations in the thickness of the plantar fascia or echogenicity
- Consumption of analgesics for plantar fasciitis for which a regular analgesic medication diary is provided

- Efecto a otros tiempos diferentes desde infiltración de los medicamentos
- Calidad vida: Cuestionario SF36
- Presencia de hallazgos ecográficos: variaciones en el grosor de la fascia plantar o de la ecogenicidad
- Consumo de analgésicos para la fascitis plantar para lo cual se facilitará un diario de medicación analgésica habitual.

E.5.2.1

Timepoint(s) of evaluation of this end point

1st secondary end point: at 7-10 days to assess possible complications after treatment and at 6 months to assess the maintenance of the treatment effect.
2st secondary end point: at month, 3 months and 6 months after treatment.
3st secondary end point: at month 3 and 6 months after treatment.
4st secondary end point: throughout treatment

1ª variable secundaria: a los 7-10 días para valorar posibles complicaciones tras el tratamiento y a los 6 meses para valorar el mantenimiento del efecto del tratamiento.
2ª variable secundaria: al mes, a los 3 y 6 meses postratamiento.
3ª variable secundaria: al mes, a los 3 y 6 meses postratamiento.
4ª variable secundaria: durante todo el tratamiento.

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

Quality of life

Calidad de vida

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

Yes

E.8.1.7.1

Other trial design description

Bajo nivel de intervención

Low-intervention

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

Yes

E.8.4

The trial involves multiple sites in the 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

LVLS. There will be the possibility of follow-up after 12 months after completing the study. The validation and analysis of the data will occupy 2 more months, at the end of which the final report and plan of communication of results will be made.

Última visita del último paciente. Existirá la posibilidad de realizar seguimiento posterior a los 12 meses tras finalizar el estudio. La validación y análisis de los datos ocuparán 2 meses más, al término de los cuales se realizará el informe final y plan de comunicación de resultados.

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:

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.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

2019-04-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-04-25

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

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