Tooth StainNCT02151058
A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal
A study testing Colgate® Regular Cavity Protection, Experimental Mouth Rinse and Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint in people with Tooth Stain, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial summary
The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest® 3D White Multi-Care Whitening Rinse, Glamorous… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Stain
- What is being tested?
- Colgate® Regular Cavity Protection, Experimental Mouth Rinse and Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years.
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
- Able to provide written informed consent;
- Male or non-pregnant, non-lactating female (self-reported)
- Male and female subjects with reproductive potential must agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product
- Medically acceptable forms of birth control that may be used by the subject and/or his/her partner
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- Able to read and understand the local language;
- Able to follow study procedures;
- Willing for this to be the only investigational product used during this time period; and
- Willing and able to comply with all study procedures and attend the scheduled visits for the duration of the study.
- Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator
Who cannot join
- Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, and marijuana) opiates.
- Females who are pregnant or breastfeeding.
- Males with a pregnant partner or a partner who is currently trying to become pregnant.
- Known sensitivity or history of significant adverse effects to any of the investigational products.
- Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study.
- Participated in tooth stain removal trials in the least 3 months
Show all 9Show fewer
- Participation in any other clinical study within 30 days of Visit 1.
- Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each).
- Other severe 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, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whitening Action of a Hydrogen Peroxide/Sodium Fluoride Containing Mouth Rinse: A 2 Week Randomized Controlled Trial
The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint). A currently marketed toothpaste (Colgate® Cavity Protection) will be included as the negative control in order to compare to brushing alone.
225 healthy volunteers will be enrolled in this two week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of 5 clinic visits including 1) screening, 2) baseline 3) Day 4 (after 3 days of use), Day 8 (after 7 days of use) and Day 15 (after 14 days of use). Volunteers will maintain a diary at home to record each treatment use. Examinations for oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with water and floss will be completed at Baseline and repeated at Clinic Visits 3, 4, and 5, which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use).
Read the detailed description
Approximately 225 generally healthy subjects that meet the required inclusion/exclusion criteria will be enrolled in this 2 week, examiner-blind, single center, randomized, controlled, parallel-group clinical trial to ensure that approximately 215 subjects complete the study. At baseline, the prescreened subjects will present to the clinical site for baseline examinations (oral tissue assessment, extrinsic tooth stain assessment). Subjects will brush with water, then floss, have an oral exam and tooth stain assessment. Subjects will be randomly assigned to one of three groups using a randomized code provided by the sponsor:
- Negative Control - Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate® Cavity Protection).
- Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate® Cavity Protection) followed by rinsing twice daily with 10 ml for 60 seconds with an investigative peroxide and fluoride containing mouth rinse
- Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate® Cavity Protection) followed by rinsing twice daily with 15 ml for 60 seconds with Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint
Immediately after randomization, subjects will begin use of their assigned test treatment. The site staff will supervise the first rinse treatment, and rinse treatments occurring on examination days. The negative control group will not have supervised brushing at the clinic to avoid the possibility of changing their usual brushing habits. All home use will be unsupervised and following label instructions. Subjects will be required to maintain a diary card to document twice-daily product use by recording their assigned oral care routine. For Clinic Visit 3, 4, and 5, subjects will be instructed to not use the treatment rinse in the morning prior to their clinic visit, because that treatment rinse will be supervised during their clinic visit. Subjects may brush as normal in the morning prior to these clinic visits.
During the study, subjects will follow their usual interdental cleaning (e.g. flossing) and dietary habits. Subjects will not be allowed to use any other unassigned oral care products (mouth rinse, dentifrice, or other tooth whitening products), or have their teeth professionally polished, bleached, or whitened by a dentist or hygienist.
Examinations for oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with water and floss will be repeated at Clinic Visits 3, 4, and 5, which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use). Compliance will be evaluated at Visits 3, 4, and 5 by weighing residual volumes of returned mouth rinses and by reviewing the subject diary. Subjects will receive the ADA-Accepted fluoride containing dentifrice and a soft bristled toothbrush at their baseline visit.
During the course of the study, subjects may use an interdental cleaning device to remove impacted food between the teeth and may continue using an interdental cleaning device regularly if it is part of their usual oral care regimen.
- Conditions
- Tooth Stain
- Being tested
- Colgate® Regular Cavity Protection, Experimental Mouth Rinse, Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint
- Keywords
- Staining, Intensity, Area
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colgate® Regular Cavity ProtectionDrug
Brushing twice daily with an ADA - Accepted fluoride - containing dentifrice (Colgate Cavity Protection)
Experimental Mouth RinseDrug
Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 10 mL for 60 seconds with the investigational product.
Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh MintOther
Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 15 mL for 60 seconds with the active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Negative Control, 035000513007 | Other | Colgate® Regular Cavity Protection Receives: Drug: Colgate® Regular Cavity Protection |
| Experimental Mouth Rinse, 19545-118 | Experimental | Not described Receives: Drug: Experimental Mouth Rinse |
| Active Comparator: Mouth Rinse 037000089872 | Active comparator | Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint Receives: Other: Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lobene Stain Index Composite Score at Day 15
Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.
The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).
Measured: 15 Days
Secondary outcomes (8)
Lobene Stain Index Composite Score at Day 4
Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.
The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).
Measured: 4 Days
Lobene Stain Index Composite Score at Day 8
Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.
The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).
Measured: 8 Days
Lobene Stain Index Area Scores at Day 4
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.
Measured: 4 Days
Lobene Stain Index Area Scores at Day 8
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.
Measured: 8 Days
Lobene Stain Index Area Scores at Day 15
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.
Measured: 15 Days
Lobene Stain Index Intensity Scores at Day 4
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.
Measured: 4 Days
Lobene Stain Index Intensity Scores at Day 8
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.
Measured: 8 Days
Lobene Stain Index Intensity Scores at Day 15
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.
Measured: 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
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.
- Other trials for Tooth StainStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Milleman Milleman, DDS, MPA, Principal investigator, Salus Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151058
- Sponsor's protocol ID
- CO-131219112750-CTOC
- Status last verified
- Oct 2014
- First submitted
- 27 May 2014
- Last updated
- 1 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whitening Action of a Hydrogen Peroxide/Sodium Fluoride Containing Mouth Rinse: A 2 Week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02151058
- Acronym / sponsor ID
- CO-131219112750-CTOC
- Conditions
- Tooth Stain
- Keywords
- Staining, Intensity, Area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Posted 1 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint). A currently marketed toothpaste (Colgate® Cavity Protection) will be included as the negative control in order to compare to brushing alone.
225 healthy volunteers will be enrolled in this two week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of 5 clinic visits including 1) screening, 2) baseline 3) Day 4 (after 3 days of use), Day 8 (after 7 days of use) and Day 15 (after 14 days of use). Volunteers will maintain a diary at home to record each treatment use. Examinations for oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with water and floss will be completed at Baseline and repeated at Clinic Visits 3, 4, and 5, which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use).
Detailed description
Approximately 225 generally healthy subjects that meet the required inclusion/exclusion criteria will be enrolled in this 2 week, examiner-blind, single center, randomized, controlled, parallel-group clinical trial to ensure that approximately 215 subjects complete the study. At baseline, the prescreened subjects will present to the clinical site for baseline examinations (oral tissue assessment, extrinsic tooth stain assessment). Subjects will brush with water, then floss, have an oral exam and tooth stain assessment. Subjects will be randomly assigned to one of three groups using a randomized code provided by the sponsor:
- Negative Control - Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate® Cavity Protection).
- Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate® Cavity Protection) followed by rinsing twice daily with 10 ml for 60 seconds with an investigative peroxide and fluoride containing mouth rinse
- Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate® Cavity Protection) followed by rinsing twice daily with 15 ml for 60 seconds with Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint
Immediately after randomization, subjects will begin use of their assigned test treatment. The site staff will supervise the first rinse treatment, and rinse treatments occurring on examination days. The negative control group will not have supervised brushing at the clinic to avoid the possibility of changing their usual brushing habits. All home use will be unsupervised and following label instructions. Subjects will be required to maintain a diary card to document twice-daily product use by recording their assigned oral care routine. For Clinic Visit 3, 4, and 5, subjects will be instructed to not use the treatment rinse in the morning prior to their clinic visit, because that treatment rinse will be supervised during their clinic visit. Subjects may brush as normal in the morning prior to these clinic visits.
During the study, subjects will follow their usual interdental cleaning (e.g. flossing) and dietary habits. Subjects will not be allowed to use any other unassigned oral care products (mouth rinse, dentifrice, or other tooth whitening products), or have their teeth professionally polished, bleached, or whitened by a dentist or hygienist.
Examinations for oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with water and floss will be repeated at Clinic Visits 3, 4, and 5, which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use). Compliance will be evaluated at Visits 3, 4, and 5 by weighing residual volumes of returned mouth rinses and by reviewing the subject diary. Subjects will receive the ADA-Accepted fluoride containing dentifrice and a soft bristled toothbrush at their baseline visit.
During the course of the study, subjects may use an interdental cleaning device to remove impacted food between the teeth and may continue using an interdental cleaning device regularly if it is part of their usual oral care regimen.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Negative Control, 035000513007 | Other | Drug: Colgate® Regular Cavity ProtectionColgate® Regular Cavity Protection |
| Experimental Mouth Rinse, 19545-118 | Experimental | Drug: Experimental Mouth Rinse |
| Active Comparator: Mouth Rinse 037000089872 | Active comparator | Other: Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh MintCrest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 - 65 years.
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
- Able to provide written informed consent;
- Male or non-pregnant, non-lactating female (self-reported)
- Male and female subjects with reproductive potential must agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product
Key exclusion criteria (9 listed)
- Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, and marijuana) opiates.
- Females who are pregnant or breastfeeding.
- Males with a pregnant partner or a partner who is currently trying to become pregnant.
- Known sensitivity or history of significant adverse effects to any of the investigational products.
- Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study.
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 |
|---|---|---|
| Colgate® Regular Cavity ProtectionBrushing twice daily with an ADA - Accepted fluoride - containing dentifrice (Colgate Cavity Protection) | Drug | Negative Control, 035000513007 |
| Experimental Mouth RinseBrushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 10 mL for 60 seconds with the investigational product. | Drug | Experimental Mouth Rinse, 19545-118 |
| Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh MintBrushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 15 mL for 60 seconds with the active comparator. | Other | Active Comparator: Mouth Rinse 037000089872 |
Primary outcome
Lobene Stain Index Composite Score at Day 15
Time frame: 15 Days
Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region. The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).
8 secondary outcomes
Lobene Stain Index Composite Score at Day 4
Time frame: 4 Days
Lobene Stain Index Composite Score at Day 8
Time frame: 8 Days
Lobene Stain Index Area Scores at Day 4
Time frame: 4 Days
Lobene Stain Index Area Scores at Day 8
Time frame: 8 Days
Lobene Stain Index Area Scores at Day 15
Time frame: 15 Days
Lobene Stain Index Intensity Scores at Day 4
Time frame: 4 Days
Lobene Stain Index Intensity Scores at Day 8
Time frame: 8 Days
Lobene Stain Index Intensity Scores at Day 15
Time frame: 15 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffery Milleman Milleman, DDS, MPA principal investigator
Salus Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colgate® Regular Cavity Protection, Experimental Mouth Rinse and Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint in people with Tooth Stain, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
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 11 inclusion and 9 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 1 Jun 2015. 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 United States. 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 1 Jun 2015). 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?
Lobene Stain Index Composite Score at Day 15 (time frame: 15 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2015.