Dentin SensitivityNCT04950465
A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population
A study testing Sensodyne Sensitivity & Gum, Crest Cavity Protection Fresh Lime and Sensodyne Repair and Protect in people with Dentin Sensitivity, run by HALEON at 1 site in China.
Trial summary
The purpose of this study is to support long-term dentinal hypersensitivity (DH) relief claims of 0.454 percent (%) stannous fluoride (SnF2) containing toothpastes in China. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Sensodyne Sensitivity & Gum, Crest Cavity Protection Fresh Lime and Sensodyne Repair and Protect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2021to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- A participant who presents the following oral and dental inclusions will apply at Screening (Visit 1):
- Self-reported history of dentinal hypersensitivity lasting more than six months but not more than 10 years.
- Good general oral health, with a minimum of 20 natural teeth.
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- Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:
- Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
- Tooth with MGI score ≤1 adjacent to the test area (exposed dentine) only and a clinical mobility of less than or equal to (<=)1.
- Tooth with signs of sensitivity measured by a qualifying tactile stimulus (yeaple [<=] 20 gram [g]) and qualifying evaporative air assessment (Schiff sensitivity score more than or equal to (>=) 2).
- The following dental inclusions will apply at Baseline (Visit 2):
- Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), with signs of sensitivity, measured by response to a qualifying tactile stimulus (yeaple <= 20g) and evaporative air assessment (Schiff sensitivity score >=2). The 2 selected 'test teeth' must have also qualified at Screening for this criteria.
- Participant must own a smartphone with the WeChat application installed.
Who cannot join
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
- A Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A participant who has participated in another tooth desensitising treatment study within 8 weeks of the Screening visit.
- A participant with, in the opinion of the investigator or medically qualified designee, has an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- A participant who is pregnant or intending to become pregnant over the duration of the study. This will be confirmed verbally at Screening.
- A participant who is breastfeeding.
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- A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- A participant who rinses with water during the first minute of toothbrushing at the Screening visit.
- A participant unwilling or unable to comply with product usage instructions or Lifestyle Considerations that will be described in the protocol.
- A participant with history of regular alcohol and/or substance abuse.
- A participant who has received treatment with another investigational product within 30 days of the first dose of investigational product.
- A participant who has had dental prophylaxis within 4 weeks of Screening, or who requires antibiotic prophylaxis for dental procedures.
- A participant with a tongue or lip piercing.
- A participant with advanced periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
- A participant who has had teeth bleaching within 8 weeks of Screening.
- A participant who has used an over-the-counter (OTC) desensitising product (Eg. dentifrice) and/or professional desensitising treatment within 8 weeks of Screening. Participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients.
- A participant with exposed tooth dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel.
- A participant with sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine Eg. current or recent dental caries, or reported treatment of decay within 12 months of Screening.
- A participant who has taken daily doses of medication/treatments or traditional herbal ingredients/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, antidepressants, mood-altering and anti-inflammatory drugs. Examples of herbal ingredients/treatments include clove oil, olive oil, or other treatments that are directly applied to the oral cavity for the treatment of oral health conditions.
- A participant who is taking antibiotics and/or has taken antibiotics within 2 weeks of Screening and/or Baseline.
- A participant who has taken daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
- Any participant who, in the judgment of the investigator, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An 8 Week, Randomised, Examiner-blind, Controlled Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population
The purpose of this study is to support long-term dentinal hypersensitivity (DH) relief claims of 0.454 percent (%) stannous fluoride (SnF2) containing toothpastes in China.
Read the detailed description
This study will be a single centre, randomised, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the 2 selected 'test teeth'), with a treatment period of 8 weeks, to investigate the clinical efficacy of a SnF2 dentifrice in the reduction of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialised negative and positive control dentifrices. Participants will be instructed to brush teeth with their assigned dentifrice according to the product use instructions provided. DH assessments will be conducted at Baseline, 4 and 8 weeks. Participants will also be requested to complete a short-form version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) at the Baseline and Week 8 Visits.
- Conditions
- Dentin Sensitivity
- Being tested
- Sensodyne Sensitivity & Gum, Crest Cavity Protection Fresh Lime, Sensodyne Repair and Protect
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensodyne Sensitivity & GumOther
Sensodyne Sensitivity \& Gum toothpaste containing 0.454% SnF2.
Crest Cavity Protection Fresh LimeOther
Crest Cavity Protection Fresh Lime is containing 1150 parts per million fluoride as Sodium fluoride.
Sensodyne Repair and ProtectOther
Sensodyne Repair and Protect dentifrice containing 5.0% weight/weight calcium sodium phosphosilicate.
| Study group | Role | What they receive |
|---|---|---|
| Test Dentifrice | Experimental | Apply a full ribbon of toothpaste on the head of the toothbrush provided. Brush teeth for 1*-timed minute, followed by brushing of the qualifying sensitive teeth. Following brushing rinse once with 10 milliliter (ml) of water from the rinsing cup provided. Receives: Other: Sensodyne Sensitivity & Gum |
| Negative Control | Active comparator | Apply a full ribbon of toothpaste on the head of the toothbrush provided; brush teeth for 1* timed minute. Following brushing rinse once with 10 ml of water from the rinsing cup provided. Receives: Other: Crest Cavity Protection Fresh Lime |
| Positive Control | Active comparator | Apply a full ribbon of toothpaste on the head of the toothbrush provided; brush teeth for 1* timed minute. Following brushing rinse once with 10 ml of water from the rinsing cup provided. Receives: Other: Sensodyne Repair and Protect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participants were scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
Measured: Baseline and Week 8
Secondary outcomes (4)
Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control)
Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20 gram (g) and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth were determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses were recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
Measured: Baseline, Week 4 and 8
Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
Measured: Baseline and Week 4
Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
Measured: Baseline, Week 4 and Week 8
Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control)
Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20g and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses would be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
Measured: Baseline, Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start27 Jul 2021
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, Preventive Dentistry Depart-ment, Shanghai Ninth Peo-ple's Hospital, Shanghai Jiao-tong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950465
- Sponsor's protocol ID
- 216954
- Status last verified
- Oct 2023
- First submitted
- 29 Jun 2021
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Li R, Yang W, Grimaldi R, Zeng P, Smith G, Chen X. Efficacy of a stannous fluoride dentifrice for relieving dentinal hypersensitivity in Chinese population: an 8-week randomized clinical trial. Clin Oral Investig. 2024 Mar 26;28(4):230. doi: 10.1007/s00784-024-05610-9.
PubMed 38530474
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8 Week, Randomised, Examiner-blind, Controlled Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population
- ClinicalTrials.gov ID
- NCT04950465
- Acronym / sponsor ID
- 216954
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to support long-term dentinal hypersensitivity (DH) relief claims of 0.454 percent (%) stannous fluoride (SnF2) containing toothpastes in China.
Detailed description
This study will be a single centre, randomised, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the 2 selected 'test teeth'), with a treatment period of 8 weeks, to investigate the clinical efficacy of a SnF2 dentifrice in the reduction of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialised negative and positive control dentifrices. Participants will be instructed to brush teeth with their assigned dentifrice according to the product use instructions provided. DH assessments will be conducted at Baseline, 4 and 8 weeks. Participants will also be requested to complete a short-form version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) at the Baseline and Week 8 Visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Dentifrice | Experimental | Other: Sensodyne Sensitivity & GumApply a full ribbon of toothpaste on the head of the toothbrush provided. Brush teeth for 1*-timed minute, followed by brushing of the qualifying sensitive teeth. Following brushing rinse once with 10 milliliter (ml) of water from the rinsing cup provided. |
| Negative Control | Active comparator | Other: Crest Cavity Protection Fresh LimeApply a full ribbon of toothpaste on the head of the toothbrush provided; brush teeth for 1* timed minute. Following brushing rinse once with 10 ml of water from the rinsing cup provided. |
| Positive Control | Active comparator | Other: Sensodyne Repair and ProtectApply a full ribbon of toothpaste on the head of the toothbrush provided; brush teeth for 1* timed minute. Following brushing rinse once with 10 ml of water from the rinsing cup provided. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- A participant who presents the following oral and dental inclusions will apply at Screening (Visit 1):
- Tooth with MGI score ≤1 adjacent to the test area (exposed dentine) only and a clinical mobility of less than or equal to (<=)1.
Key exclusion criteria (22 listed)
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
- A Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A participant who has participated in another tooth desensitising treatment study within 8 weeks of the Screening visit.
- A participant with, in the opinion of the investigator or medically qualified designee, has an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- A participant who is pregnant or intending to become pregnant over the duration of the study. This will be confirmed verbally at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensodyne Sensitivity & GumSensodyne Sensitivity \& Gum toothpaste containing 0.454% SnF2. | Other | Test Dentifrice |
| Crest Cavity Protection Fresh LimeCrest Cavity Protection Fresh Lime is containing 1150 parts per million fluoride as Sodium fluoride. | Other | Negative Control |
| Sensodyne Repair and ProtectSensodyne Repair and Protect dentifrice containing 5.0% weight/weight calcium sodium phosphosilicate. | Other | Positive Control |
Primary outcome
Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control)
Time frame: Baseline and Week 8
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participants were scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
4 secondary outcomes
Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control)
Time frame: Baseline, Week 4 and 8
Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control)
Time frame: Baseline and Week 4
Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control)
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control)
Time frame: Baseline, Week 4 and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38530474Li R, Yang W, Grimaldi R, Zeng P, Smith G, Chen X. Efficacy of a stannous fluoride dentifrice for relieving dentinal hypersensitivity in Chinese population: an 8-week randomized clinical trial. Clin Oral Investig. 2024 Mar 26;28(4):230. doi: 10.1007/s00784-024-05610-9.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
Preventive Dentistry Depart-ment, Shanghai Ninth Peo-ple's Hospital, Shanghai Jiao-tong University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensodyne Sensitivity & Gum, Crest Cavity Protection Fresh Lime and Sensodyne Repair and Protect in people with Dentin Sensitivity, run by HALEON at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04950465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.