A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children

July 20, 2026 updated by: Colgate Palmolive

A Phase 2 Randomized, Double-blind, Active-controlled Multi-center Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices With 1.5%, 4.0% and 8.0% Arginine Each in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children

The objective of this study is to assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2025

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects meeting all criteria below will be included in the study:

    1. Subject assent and parental/guardian informed consent for voluntary participation.
    2. Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial.
    3. Children ages 10-14 years at baseline.
    4. Presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa.
    5. Good general health as evidenced by a review of the medical history.
    6. Subjects who, at study entry, have present two or more active caries lesions (ICDAS scores of 2 or greater) in permanent teeth and previous caries experience (DMFT >1), D= Decayed is defined as ICDAS scores of 3 or greater

Exclusion Criteria:

  • Subjects presenting any of the criteria below will be excluded from the study:

    1. Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth.

    2. Use of medication that could increase the risk of developing dental caries, i.e.

      medications that reduce saliva flow and those with high sugar content.

    3. Long-term antibiotic therapy.
    4. Children with a confirmed diagnosis of cognitive and/or motor impairment.
    5. Severe malocclusion.
    6. Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth.
    7. Evidence of moderate to severe periodontal disease.
    8. Participation in any other clinical study within the 30 days preceding the start of the clinical study.
    9. Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
    10. Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 0.24% Sodium Fluoride Dentifrice
Toothpaste
Drug: 0.24% Sodium Fluoride Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Experimental: 1.5% Arginine Dentifrice
Toothpaste
Drug: 1.5% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Experimental: 4.0% Arginine Dentifrice
Toothpaste
Drug: 4.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Experimental: 8.0% Arginine Dentifrice
Toothpaste
Drug: 8.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Colgate Palmolive

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maria E Ryan, DDS PhD, Colgate-Palmolive Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRO-2020-CAR-ARG-ED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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