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Een klinisch onderzoek om de veiligheid en de werkzaamheid tegen cariës te beoordelen van COL 101 (arginine) niet-fluoride tandpasta's in vergelijking met 0,24% natriumfluoride (1100 Ppm F) tandpastacontrole bij 10 tot 14-jarige kinderen

20 juli 2026 bijgewerkt door: Colgate Palmolive

Een fase 2 gerandomiseerde, dubbelblinde, actief gecontroleerde klinische studie in meerdere centra om de veiligheid en de werkzaamheid tegen cariës te beoordelen van COL 101 (arginine) niet-fluoride tandpasta's met elk 1,5%, 4,0% en 8,0% arginine in vergelijking Met 0,24% natriumfluoride (1100 Ppm F) Tandpastacontrole bij kinderen van 10 tot 14 jaar

Het doel van deze studie is om de veiligheid te beoordelen en de werkzaamheid tegen cariës te evalueren van COL101 (arginine) niet-fluoride tandpasta's in vergelijking met een 0,24% natriumfluoride tandpasta bij 10-14-jarige kinderen gedurende een periode van een jaar.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

In this phase 2, double-blind, randomized, active-controlled multi-center study, 2025 subjects were randomized in a ratio of 1:1:1:1 into one of four parallel study groups (1.5% arginine dentifrice, 4.0% arginine dentifrice, 8.0% arginine dentifrice or 0.24% NaF dentifrice with no arginine). Subjects were asked to brush their teeth twice daily at home (unsupervised use) with the assigned dentifrice for a duration of 1 year. Measurements for efficacy, safety and assessment of product use compliance were conducted at baseline, 6 months (±1 month) and 1 year (±1 month). Additional safety evaluations including evaluation of oral soft and hard tissues, as well as product use compliance assessment was performed at 3 months and 9 months (±1 month). All subjects were monitored for adverse events (AEs) during the course of the study.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

2025

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Puerto Rico
      • San Juan, Puerto Rico
        • University of Puerto Rico School of Dental Medicine
  • Verenigde Staten
    • California
      • Loma Linda, California, Verenigde Staten, 92350
        • Loma Linda University School of Dentistry
    • Florida
      • Gainesville, Florida, Verenigde Staten, 32610
        • University of Florida College of Dentistry
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46202-2876
        • Indiana University School of Dentistry
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02111
        • Tufts University School of Dental Medicine
      • Boston, Massachusetts, Verenigde Staten, 02142
        • The Forsyth Institute
    • New York
      • Buffalo, New York, Verenigde Staten, 14214
        • University at Buffalo School of Dental Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104-6003
        • University of Pennsylvania School of Dental Medicine
    • Texas
      • San Antonio, Texas, Verenigde Staten, 78229-3900
        • UT Health San Antonio School of Dentistry

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

10 jaar tot 14 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusiecriteria:

  • Proefpersonen die aan alle onderstaande criteria voldoen, zullen in het onderzoek worden opgenomen:

    1. Toestemming van de proefpersoon en geïnformeerde toestemming van ouder/voogd voor vrijwillige deelname.
    2. Bereidheid en mogelijkheid om de toegewezen producten te gebruiken volgens de instructies, beschikbaarheid voor alle afspraken en de waarschijnlijkheid dat de klinische proef wordt voltooid.
    3. Kinderen van 10-14 jaar bij baseline.
    4. Aanwezigheid van blijvende tweede kiezen of tekenen van uitbarsting van ten minste één blijvende tweede kies, zoals blijkt uit een doorbraak van de knobbel door het slijmvlies.
    5. Goede algemene gezondheid zoals blijkt uit een beoordeling van de medische geschiedenis.
    6. Proefpersonen die bij aanvang van het onderzoek twee of meer actieve cariëslaesies (ICDAS-scores van 2 of hoger) in blijvende tanden en eerdere cariëservaring (DMFT >1) hebben, D= Decayed wordt gedefinieerd als ICDAS-scores van 3 of hoger

Uitsluitingscriteria:

  • Onderwerpen die een van de onderstaande criteria vertonen, worden uitgesloten van het onderzoek:

    1. Aanwezigheid van een vaste of uitneembare prothese of orthodontische behandeling waarbij meer dan vier blijvende tanden betrokken zijn.

    2. Gebruik van medicijnen die het risico op tandcariës kunnen verhogen, d.w.z.

      medicijnen die de speekselvloed verminderen en medicijnen met een hoog suikergehalte.

    3. Langdurige antibiotische therapie.
    4. Kinderen met een bevestigde diagnose van cognitieve en/of motorische stoornissen.
    5. Ernstige malocclusie.
    6. Proefpersonen die bij aanvang van de studie ernstige cariës (ICDAS 5 of 6) hebben op vijf of meer permanente tanden.
    7. Bewijs van matige tot ernstige parodontitis.
    8. Deelname aan een andere klinische studie binnen de 30 dagen voorafgaand aan de start van de klinische studie.
    9. Bekende geschiedenis van allergieën of andere bijwerkingen van arginine, of mondverzorgingsproducten, of hun ingrediënten.
    10. Zelfgerapporteerde geschiedenis van momenteel zwanger zijn, van plan zijn zwanger te worden tijdens de proefperiode of borstvoeding geven.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 0,24% natriumfluoride tandpasta
Tandpasta
Geneesmiddel: 0,24% natriumfluoride tandpasta
De hele mond poetsen met een tandpasta, 2 keer per dag gedurende 2 minuten per keer voor de duur van het onderzoek
Experimenteel: 1,5% Arginine Tandpasta
Tandpasta
Geneesmiddel: 1,5% Arginine Tandpasta
De hele mond poetsen met een tandpasta, 2 keer per dag gedurende 2 minuten per keer voor de duur van het onderzoek
Experimenteel: 4,0% Arginine Tandpasta
Tandpasta
Geneesmiddel: 4,0% Arginine Tandpasta
De hele mond poetsen met een tandpasta, 2 keer per dag gedurende 2 minuten per keer voor de duur van het onderzoek
Experimenteel: 8,0% Arginine Tandpasta
Tandpasta
Geneesmiddel: 8,0% Arginine Tandpasta
De hele mond poetsen met een tandpasta, 2 keer per dag gedurende 2 minuten per keer voor de duur van het onderzoek

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits
Tijdsspanne: Between the Baseline and the Month 12 visits
The Decayed Missing or Filled Surfaces (DMFS) score is a measure of the extent of dental caries for a subject, defined as the number of scorable tooth surfaces among the up to 128 examined surfaces in the subject's mouth that were determined by the examiner to be decayed, missing, or filled. This score can range between 0 and 128, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFS is defined as the change in DMFS score between two examinations performed at specified time points, calculated by subtraction.
Between the Baseline and the Month 12 visits

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits
Tijdsspanne: Between the Baseline and the Month 6 visits
The Decayed Missing or Filled Surfaces (DMFS) score is a measure of the extent of dental caries for a subject, defined as the number of scorable tooth surfaces among the up to 128 examined surfaces in the subject's mouth that were determined by the examiner to be decayed, missing, or filled. This score can range between 0 and 128, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFS is defined as the change in DMFS score between two examinations performed at specified time points, calculated by subtraction.
Between the Baseline and the Month 6 visits
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Month 6 and Month 12 Visits
Tijdsspanne: Between the Month 6 and the Month 12 visits
The Decayed Missing or Filled Surfaces (DMFS) score is a measure of the extent of dental caries for a subject, defined as the number of scorable tooth surfaces among the up to 128 examined surfaces in the subject's mouth that were determined by the examiner to be decayed, missing, or filled. This score can range between 0 and 128, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFS is defined as the change in DMFS score between two examinations performed at specified time points, calculated by subtraction.
Between the Month 6 and the Month 12 visits
Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 6 Visits
Tijdsspanne: Between the Baseline and the Month 6 visits
The Decayed Missing or Filled Teeth (DMFT) score is a measure of the extent of dental caries for a subject, defined as the number of the up to 28 examined teeth in the subject's mouth on which the examiner determined at least one surface to be decayed, missing, or filled. This score can range between 0 and 28, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFT is defined as the change in DMFT score between two examinations performed at specified time points, calculated by subtraction.
Between the Baseline and the Month 6 visits
Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 12 Visits
Tijdsspanne: Between the Baseline and the Month 12 visits
The Decayed Missing or Filled Teeth (DMFT) score is a measure of the extent of dental caries for a subject, defined as the number of the up to 28 examined teeth in the subject's mouth on which the examiner determined at least one surface to be decayed, missing, or filled. This score can range between 0 and 28, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFT is defined as the change in DMFT score between two examinations performed at specified time points calculated by subtraction.
Between the Baseline and the Month 12 visits
Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Month 6 and the Month 12 Visits
Tijdsspanne: Between the Month 6 and the Month 12 visits
The Decayed Missing or Filled Teeth (DMFT) score is a measure of the extent of dental caries for a subject, defined as the number of the up to 28 examined teeth in the subject's mouth on which the examiner determined at least one surface to be decayed, missing, or filled. This score can range between 0 and 28, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFT is defined as the change in DMFT score between two examinations performed at specified time points, calculated by subtraction.
Between the Month 6 and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Severity Score Progressions Between the Baseline and the Month 6 Visits
Tijdsspanne: Between the Baseline and the Month 6 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 2 or higher; from a score of 1 or 2 to a score of 3 or higher; or from a score of 3 or 4 to a score of 5 or 6. Surfaces with scores between 0 and 4 at the earlier examination are defined as being at risk for caries severity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries progression was calculated.
Between the Baseline and the Month 6 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Severity Score Progressions Between the Baseline and the Month 12 Visits
Tijdsspanne: Between the Baseline and the Month 12 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 2 or higher; from a score of 1 or 2 to a score of 3 or higher; or from a score of 3 or 4 to a score of 5 or 6. Surfaces with scores between 0 and 4 at the earlier examination are defined as being at risk for caries severity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries progression was calculated.
Between the Baseline and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Severity Score Progressions Between the Month 6 and the Month 12 Visits
Tijdsspanne: Between the Month 6 and the Month 12 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 2 or higher; from a score of 1 or 2 to a score of 3 or higher; or from a score of 3 or 4 to a score of 5 or 6. Surfaces with scores between 0 and 4 at the earlier examination are defined as being at risk for caries severity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries progression was calculated.
Between the Month 6 and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Severity Score Regressions Between the Baseline and the Month 6 Visits
Tijdsspanne: Between the Baseline and the Month 6 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score severity score regression on a tooth surface is defined as an improvement from a score of 2 or higher to a score of 0 or 1. Tooth surfaces for which the earlier score was between 2 and 6 are defined as being at risk for caries severity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries regression was calculated.
Between the Baseline and the Month 6 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Severity Score Regressions Between the Baseline and the Month 12 Visits
Tijdsspanne: Between the Baseline and the Month 12 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score severity score regression on a tooth surface is defined as an improvement from a score of 2 or higher to a score of 0 or 1. Tooth surfaces for which the earlier score was between 2 and 6 are defined as being at risk for caries severity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries regression was calculated.
Between the Baseline and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Severity Score Regressions Between the Month 6 and the Month 12 Visits
Tijdsspanne: Between the Month 6 and the Month 12 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score severity score regression on a tooth surface is defined as an improvement from a score of 2 or higher to a score of 0 or 1. Tooth surfaces for which the earlier score was between 2 and 6 are defined as being at risk for caries severity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries regression was calculated.
Between the Month 6 and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Progressions Between the Baseline and the Month 6 Visits
Tijdsspanne: Between the Baseline and the Month 6 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 1. Surfaces with a score of 0 at the earlier examination are defined as being at risk for caries activity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity progression was calculated.
Between the Baseline and the Month 6 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Progressions Between the Baseline and the Month 12 Visits
Tijdsspanne: Between the Baseline and the Month 12 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 1. Surfaces with a score of 0 at the earlier examination are defined as being at risk for caries activity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity progression was calculated.
Between the Baseline and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Progressions Between the Month 6 and the Month 12 Visits
Tijdsspanne: Between the Month 6 and the Month 12 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 1. Surfaces with a score of 0 at the earlier examination are defined as being at risk for caries activity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity progression was calculated.
Between the Month 6 and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Regressions Between the Baseline and the Month 6 Visits
Tijdsspanne: Between the Baseline and the Month 6 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score regression is defined as an improvement from a score of 1 to a score of 0. Surfaces with a score of 1 at the earlier examination are defined as being at risk for caries activity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity regression was calculated.
Between the Baseline and the Month 6 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Regressions Between the Baseline and the Month 12 Visits
Tijdsspanne: Between the Baseline and the Month 12 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score regression is defined as an improvement from a score of 1 to a score of 0. Surfaces with a score of 1 at the earlier examination are defined as being at risk for caries activity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity regression was calculated.
Between the Baseline and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Regressions Between the Month 6 and the Month 12 Visits
Tijdsspanne: Between the Month 6 and the Month 12 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score regression is defined as an improvement from a score of 1 to a score of 0. Surfaces with a score of 1 at the earlier examination are defined as being at risk for caries activity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity regression was calculated
Between the Month 6 and the Month 12 visits

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Colgate Palmolive

Onderzoekers

  • Studie directeur: Maria E Ryan, DDS PhD, Colgate-Palmolive Company

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 januari 2021

Primaire voltooiing (Werkelijk)

28 februari 2024

Studie voltooiing (Werkelijk)

28 februari 2024

Studieregistratiedata

Eerst ingediend

8 februari 2021

Eerst ingediend dat voldeed aan de QC-criteria

10 februari 2021

Eerst geplaatst (Werkelijk)

11 februari 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

20 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CRO-2020-CAR-ARG-ED

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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