Et klinisk forsøg for at vurdere sikkerheden og anti-caries-effektiviteten af COL 101 (arginin) non-fluorid tandplejemidler i sammenligning med 0,24 % natriumfluorid (1100 ppm F) tandplejemiddelkontrol hos 10 til 14-årige børn
20. juli 2026 opdateret af: Colgate Palmolive
Et fase 2 randomiseret, dobbeltblindt, aktivt kontrolleret multicenter klinisk forsøg for at vurdere sikkerheden og anticarieseffektiviteten af COL 101 (arginin) non-fluorid tandplejemidler med 1,5 %, 4,0 % og 8,0 % arginin hver i sammenligning Med 0,24 % natriumfluorid (1100 ppm F) tandplejemiddelkontrol hos 10 til 14-årige børn
Formålet med denne undersøgelse er at vurdere sikkerheden og at evaluere anti-caries-effektiviteten af COL101 (arginin) non-fluorid tandplejemidler sammenlignet med et 0,24 % natriumfluorid tandplejemiddel hos 10-14-årige børn over en periode på et år.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2025
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Loma Linda, California, Forenede Stater, 92350
- Loma Linda University School of Dentistry
-
-
Florida
-
Gainesville, Florida, Forenede Stater, 32610
- University of Florida College of Dentistry
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202-2876
- Indiana University School of Dentistry
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02111
- Tufts University School of Dental Medicine
-
Boston, Massachusetts, Forenede Stater, 02142
- The Forsyth Institute
-
-
New York
-
Buffalo, New York, Forenede Stater, 14214
- University at Buffalo School of Dental Medicine
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104-6003
- University of Pennsylvania School of Dental Medicine
-
-
Texas
-
San Antonio, Texas, Forenede Stater, 78229-3900
- UT Health San Antonio School of Dentistry
-
-
-
-
-
San Juan, Puerto Rico
- University of Puerto Rico School of Dental Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
10 år til 14 år (Barn)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
Emner, der opfylder alle kriterier nedenfor, vil blive inkluderet i undersøgelsen:
- Emnets samtykke og informeret samtykke fra forældre/værge til frivillig deltagelse.
- Vilje og evne til at bruge de tildelte produkter i henhold til instruktionerne, tilgængelighed til alle aftaler og sandsynlighed for at gennemføre det kliniske forsøg.
- Børn i alderen 10-14 år ved baseline.
- Tilstedeværelse af permanente sekundære kindtænder eller tegn på, at mindst én permanent anden kindtand er udbrudt, som angivet ved cuspalbrud gennem slimhinden.
- Godt generelt helbred, som det fremgår af en gennemgang af sygehistorien.
- Forsøgspersoner, som ved studiestart har vist to eller flere aktive carieslæsioner (ICDAS-score på 2 eller mere) i permanente tænder og tidligere carieserfaring (DMFT >1), D= Decayed er defineret som ICDAS-score på 3 eller derover
Ekskluderingskriterier:
Emner, der præsenterer et af nedenstående kriterier, vil blive udelukket fra undersøgelsen:
- Tilstedeværelse af fast eller aftageligt proteseapparat eller ortodontisk behandling, der involverer mere end fire permanente tænder.
Brug af medicin, der kan øge risikoen for udvikling af tandkaries, dvs.
medicin, der reducerer spytstrømmen og dem med højt sukkerindhold.
- Langvarig antibiotikabehandling.
- Børn med en bekræftet diagnose af kognitiv og/eller motorisk svækkelse.
- Alvorlig malocclusion.
- Forsøgspersoner, der ved studiestart har til stede svær caries (ICDAS 5 eller 6) på fem eller flere permanente tænder.
- Bevis på moderat til svær paradentose.
- Deltagelse i enhver anden klinisk undersøgelse inden for de 30 dage forud for starten af den kliniske undersøgelse.
- Kendt historie med allergier eller andre negative reaktioner på arginin eller mundplejeprodukter eller deres ingredienser.
- Selvrapporteret historie om at være aktuelt gravid, påtænke at blive gravid i løbet af prøveperioden eller amning.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 0,24% natriumfluorid tandplejemiddel
Tandpasta
|
Børstning af hele munden med tandpasta 2 gange om dagen i 2 minutter hver gang i hele undersøgelsens varighed
|
|
Eksperimentel: 1,5% arginin tandplejemiddel
Tandpasta
|
Børstning af hele munden med tandpasta 2 gange om dagen i 2 minutter hver gang i hele undersøgelsens varighed
|
|
Eksperimentel: 4,0% arginin tandplejemiddel
Tandpasta
|
Børstning af hele munden med tandpasta 2 gange om dagen i 2 minutter hver gang i hele undersøgelsens varighed
|
|
Eksperimentel: 8,0% arginin tandplejemiddel
Tandpasta
|
Børstning af hele munden med tandpasta 2 gange om dagen i 2 minutter hver gang i hele undersøgelsens varighed
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Maria E Ryan, DDS PhD, Colgate-Palmolive Company
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. januar 2021
Primær færdiggørelse (Faktiske)
28. februar 2024
Studieafslutning (Faktiske)
28. februar 2024
Datoer for studieregistrering
Først indsendt
8. februar 2021
Først indsendt, der opfyldte QC-kriterier
10. februar 2021
Først opslået (Faktiske)
11. februar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRO-2020-CAR-ARG-ED
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .