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    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-005511-32
    A.3Full 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.3.1Title 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.4.1Sponsor's protocol code numberXEOLAS
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorXeolas Pharmaceuticals Ltd.
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportXeolas Pharmaceuticals Ltd.
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInternational University of Catalonia (UIC)
    B.5.2Functional name of contact pointJordi Caballé Serrano
    B.5.3 Address:
    B.5.3.1Street AddressCarrer de la Immaculada, 22
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08017
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932541800
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Soludronate Semanal 70 mg solución oral
    D.2.1.1.2Name of the Marketing Authorisation holderSoludronate
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSoludronate
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSoludronate Semanal
    D.3.9.2Current sponsor codeXEOLAS
    D.3.9.3Other descriptive nameALENDRONIC ACID
    D.3.9.4EV Substance CodeSUB05307MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical 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.1.1.1Medical 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.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(s) of evaluation of this end point
    15 days, 3 months
    15 días, 3 meses
    E.5.2Secondary end point(s)
    Not provided
    No disponible
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not provided
    No disponible
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-06
    P. End of Trial
    P.End of Trial StatusOngoing
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