Clinical Trials Register

Summary
EudraCT Number:	2021-005511-32
Sponsor's Protocol Code Number:	XEOLAS
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:	2022-03-10
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

2021-005511-32

A.3

Full title of the trial

A Randomized Control Trial Phase (IIIa) Unicentric, Placebo Controlled, Double-Blinded Study to confirm the Efficacy and Safety of “Effects of topical Alendronic Acid on alveolar bone remodeling after tooth extraction: a pilot study”.

Ensayo aleatorizado en fase IIIa unicéntrico, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de los “Efectos del ácido alendrónico tópico en la remodelación del hueso alveolar tras la extracción dental: estudio piloto”

A.3.1

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

Clinical trial to confirm the effectiveness and safety of a topical medicine, on a bone remodeling after a tooth extraction.

Ensayo clínico para comprobar la efectividad y seguridad de un medicamento tópico , en una remodelación ósea tras extracción dental.

A.4.1

Sponsor's protocol code number

XEOLAS

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	Xeolas Pharmaceuticals Ltd.
B.1.3.4	Country	Ireland
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	Xeolas Pharmaceuticals Ltd.
B.4.2	Country	Ireland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	International University of Catalonia (UIC)
B.5.2	Functional name of contact point	Jordi Caballé Serrano
B.5.3	Address:
B.5.3.1	Street Address	Carrer de la Immaculada, 22
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08017
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34932541800

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	Soludronate Semanal 70 mg solución oral
D.2.1.1.2	Name of the Marketing Authorisation holder	Soludronate
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	Soludronate
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Buccal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Soludronate Semanal
D.3.9.2	Current sponsor code	XEOLAS
D.3.9.3	Other descriptive name	ALENDRONIC ACID
D.3.9.4	EV Substance Code	SUB05307MIG
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	70
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	Oral solution
D.8.4	Route of administration of the placebo	Buccal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Healthy patients periodontal disease, that qualify for oral surgery of the alveolar bone(ASA I and II)

Pacientes sanos con enfermedad periodontal, que cumplen los requisitos para cirugía oral del hueso alveolar (ASA I y II)

E.1.1.1

Medical condition in easily understood language

Periodontal disease, can cause damage of gums and bones that support the teeth.

Enfermedad periodontal, puede producir el deterioro de hueso y encias que soportan los dientes.

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

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 assess the maintenance of at least 6 mm of bone width and 75% of volume at the tooth extraction location in Soludronate, treated teeth extraction sockets.

Evaluar el mantenimiento de al menos 6 mm de ancho óseo y 75% del volumen en el lugar de extracción del diente en alveolos de extracción de dientes tratados con Soludronate®.

E.2.2

Secondary objectives of the trial

Not applicable

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provide signed and dated informed consent form.
2. Overall, healthy patients that qualify for oral surgery (ASA I and II).
3. Male and female patients 18-90 (inclusive) years of age.
4. Requiring extraction of 1 tooth (maxillary or mandibular).
5. Stable post-extraction socket walls with at least 4 walls.
6. Adequate oral hygiene: plaque index < 25% before the surgery.
7. Non-smoker or smoker of <10 cigarettes per day.
8. Able to follow the instructions and able to meet the follow-ups.
9. Healthy or controlled periodontal disease.

1. Entregar un consentimiento informado firmado y actualizado.
2. Pacientes sanos, que cumplen los requisitos para cirugía oral (ASA I y II).
3. Mujeres y hombres de 18-90 de años (inclusive).
4. Necesidad de extracción de un diente (maxilar o mandibular).
5.Paredes alveolares estables post-extracción con al menos 4 paredes.
6. Higiene oral adecuada: índice de placa< 25% antes de la cirugía.
7. No fumadores o fumadores de <10 cigarros al día.
8. Ser capaz de seguir instrucciones e ir a las consultas
9. Tener enfermedad periodontal controlada o sana.

E.4

Principal exclusion criteria

1. Patients who not agree with informed consent.
2. Male and female patients are not 18-90 (inclusive) years of age.
3. Untreated periodontal disease.
4. Presence of dehiscence and/or fenestration at buccal plate of the extraction tooth/teeth.
5. Patient who will need guided bone regeneration (GBR) or Block Regeneration after the extraction.
6.History of head and/or neck radiation.
7. History of chemotherapy in the five years prior of the surgery.
8. Non controlled Diabetes.
9. Chronic corticoids medication that may influence healing and/or osseointegration.
10. Smoker of >10 cigars per day.
11. Pregnant woman.
12. Alcohol or drugs.

1. Pacientes que no estén de acuerdo con el consentimiento informado.
2. Pacientes menores de 18 años y mayores de 90 años.
3. Enfermedad periodontal sin tratar.
4. Presencia de dehiscencia y / o fenestración en la placa vestibular del diente / dientes de extracción.
5. Paciente que necesitará regeneración ósea guiada o regeneración en bloque después de la extracción.
6. Pacientes con historia de radioterapia en cabeza y/o cuello.
7.Pacientes que hayan pasado por quimioterapia 5 años antes de la operación.
8. Pacientes medicados con corticoides que puedan influir en el proceso de osteointegración.
9. Diabetes no controlada.
10. Fumadores de > 10 cigarros diarios
11. Mujeres embarazadas
12. Alcohol o drogas
13. Pacientes medicados con bisfosfonato o Denosumab (Prolia®).

E.5 End points

E.5.1

Primary end point(s)

Buccal and lingual vertical and horizontal bone socket dimensions will be measured by CBCT. Three dimensional volumetric changes in hard tissue will be measured in (mm).

Las dimensiones de la cavidad ósea vertical y horizontal bucal y lingual se medirán mediante CBCT dental. Los cambios volumétricos tridimensionales en el tejido duro se medirán en (mm).

E.5.1.1

Timepoint(s) of evaluation of this end point

15 days, 3 months

15 días, 3 meses

E.5.2

Secondary end point(s)

Not provided

No disponible

E.5.2.1

Timepoint(s) of evaluation of this end point

Not provided

No disponible

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

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.8.2.4

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

ultima visita 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:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

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

2022-09-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-06

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

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