En klinisk prövning för att utvärdera säkerheten och anti-karieseffekten av COL 101 (arginin) icke-fluorid-tandkrämer i jämförelse med 0,24 % natriumfluorid (1100 ppm F) tandkrämskontroll hos 10 till 14-åriga barn
20 juli 2026 uppdaterad av: Colgate Palmolive
En fas 2 randomiserad, dubbelblind, aktivt kontrollerad multicenter klinisk prövning för att bedöma säkerheten och anti-karieseffektiviteten av COL 101 (arginin) icke-fluorid tandkrämer med 1,5 %, 4,0 % och 8,0 % arginin vardera i jämförelse Med 0,24 % natriumfluorid (1100 ppm F) tandkrämskontroll hos 10 till 14-åriga barn
Syftet med denna studie är att utvärdera säkerheten och att utvärdera anti-karies-effekten av COL101 (arginin) icke-fluorid-tandkrämer jämfört med en 0,24% natriumfluorid-tandkräm hos 10-14-åriga barn under en ettårsperiod.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
2025
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Loma Linda, California, Förenta staterna, 92350
- Loma Linda University School of Dentistry
-
-
Florida
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Gainesville, Florida, Förenta staterna, 32610
- University of Florida College of Dentistry
-
-
Indiana
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Indianapolis, Indiana, Förenta staterna, 46202-2876
- Indiana University School of Dentistry
-
-
Massachusetts
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Boston, Massachusetts, Förenta staterna, 02111
- Tufts University School of Dental Medicine
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Boston, Massachusetts, Förenta staterna, 02142
- The Forsyth Institute
-
-
New York
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Buffalo, New York, Förenta staterna, 14214
- University at Buffalo School of Dental Medicine
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-
Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104-6003
- University of Pennsylvania School of Dental Medicine
-
-
Texas
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San Antonio, Texas, Förenta staterna, 78229-3900
- UT Health San Antonio School of Dentistry
-
-
-
-
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San Juan, Puerto Rico
- University of Puerto Rico School of Dental Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
10 år till 14 år (Barn)
Tar emot friska volontärer
Ja
Beskrivning
Inklusionskriterier:
Ämnen som uppfyller alla kriterier nedan kommer att inkluderas i studien:
- Subjektets samtycke och informerat samtycke från föräldrar/vårdnadshavare för frivilligt deltagande.
- Vilja och förmåga att använda de tilldelade produkterna enligt instruktioner, tillgänglighet för alla möten och sannolikhet att slutföra den kliniska prövningen.
- Barn i åldrarna 10-14 år vid baslinjen.
- Närvaro av permanenta andra molarer eller tecken på att minst en permanent andra molar bryter ut, vilket indikeras av cuspal genombrott genom slemhinnan.
- God allmän hälsa vilket framgår av en genomgång av sjukdomshistorien.
- Försökspersoner som vid studiestart har uppvisat två eller flera aktiva karieslesioner (ICDAS-poäng på 2 eller högre) i permanenta tänder och tidigare karieserfarenhet (DMFT >1), D= Decayed definieras som ICDAS-poäng på 3 eller mer
Exklusions kriterier:
Ämnen som presenterar något av kriterierna nedan kommer att exkluderas från studien:
- Förekomst av fast eller avtagbar protesanordning eller ortodontisk behandling som involverar fler än fyra permanenta tänder.
Användning av läkemedel som skulle kunna öka risken för att utveckla tandkaries, d.v.s.
mediciner som minskar salivflödet och de med högt sockerinnehåll.
- Långvarig antibiotikabehandling.
- Barn med en bekräftad diagnos av kognitiv och/eller motorisk funktionsnedsättning.
- Allvarlig malocklusion.
- Försökspersoner som vid studiestart har allvarlig karies (ICDAS 5 eller 6) på fem eller fler permanenta tänder.
- Bevis på måttlig till svår periodontal sjukdom.
- Deltagande i någon annan klinisk studie inom 30 dagar före starten av den kliniska studien.
- Känd historia av allergier eller andra biverkningar mot arginin, eller munvårdsprodukter, eller deras ingredienser.
- Självrapporterad historia av att vara gravid, avser att bli gravid under försöksperioden eller amning.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 0,24% natriumfluorid tandkräm
Tandkräm
|
Hela munnen borsta med en tandkräm, 2 gånger/dag i 2 minuter varje gång under hela studien
|
|
Experimentell: 1,5% arginin tandkräm
Tandkräm
|
Hela munnen borsta med en tandkräm, 2 gånger/dag i 2 minuter varje gång under hela studien
|
|
Experimentell: 4,0% arginin tandkräm
Tandkräm
|
Hela munnen borsta med en tandkräm, 2 gånger/dag i 2 minuter varje gång under hela studien
|
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Experimentell: 8,0% arginin tandkräm
Tandkräm
|
Hela munnen borsta med en tandkräm, 2 gånger/dag i 2 minuter varje gång under hela studien
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Maria E Ryan, DDS PhD, Colgate-Palmolive Company
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
21 januari 2021
Primärt slutförande (Faktisk)
28 februari 2024
Avslutad studie (Faktisk)
28 februari 2024
Studieregistreringsdatum
Först inskickad
8 februari 2021
Först inskickad som uppfyllde QC-kriterierna
10 februari 2021
Första postat (Faktisk)
11 februari 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CRO-2020-CAR-ARG-ED
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .