HealthyPhase 1NCT06823284
To Assess the Bioavailability of TK-254RX in Comparison with Oral Flurbiprofen Tablets and the Adhesion of TK-254RX in Healthy Subjects
A Phase 1 study testing Esflurbiprofen Topical System and Flurbiprofen tablet in people with Healthy, run by Teikoku Seiyaku Co., Ltd. at 1 site in Germany.
Trial summary
This study is a single-center, open-label, multiple-dose trial performed in a 2-period, 2- sequence-cross-over design in healthy volunteers. The primary purpose of this study is to assess non-superiority of the bioavailability of TK-254RX compared with that of a marketed oral flurbiprofen-containing tablet formulation… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Esflurbiprofen Topical System and Flurbiprofen tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jan 2025to 24 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 18 years to 64 years (inclusive)
- body-mass index (BMI): ≥18.5 kg/m² and ≤ 30.0 kg/m²
- good state of health
- non-smoker or ex-smoker for at least 3 months
- written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical triall
Who cannot join
- existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- existing or history of hypertension and/or heart failure
- existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- history of gastrointestinal bleeding or perforation related to previous NSAID therapy
- active, or history of ulcerative colitis, Crohn's disease, peptic ulceration or gastrointestinal haemorrhage
Show all 42Show fewer
- existing metabolic, endocrine and/or immunologic diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- diabetes mellitus
- hyperlipidaemia (LDL > 4.16 mmol/l, HDL < 0.91 mmol/l, triglycerides > 2.28 mmol/l, cholesterol > 6.24 mmol/l)
- history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- presence or history of acute or chronic diseases of the skin (e.g., atopic dermatitis (eczema), neurodermatitis, contact allergy, psoriasis, vitiligo, melanoma, squamous cell carcinoma), any dermatological condition or skin sensitivity which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- existing or history of bronchial asthma
- known allergic reactions (e.g., bronchospasm, rhinitis, angioedema, or urticaria) to the active ingredients used, to acetylsalicylic acid or other NSAIDs, or to constituents of the pharmaceutical preparations
- history of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
- galactose intolerance or Lapp lactase deficiency
- systolic blood pressure < 90 or > 139 mmHg
- diastolic blood pressure < 60 or > 89 mmHg
- heart rate < 50 bpm or > 90 bpm
- QTc interval > 450 ms for men and > 470 ms for women
- laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
- ASAT > 20% ULN, ALAT > 10% ULN, bilirubin > 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine > 0.1 mg/dL ULN (limit of > 0.1 mg/dL correspondents to > 9 µmol/l ULN)
- positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or anti-HCV-test
- vaccination against COVID-19 within the last 4 weeks prior to individual intended IMP administration
- skin abnormality (e.g., tattoo (including tattoo that was removed), scar, sunburn, or obvious difference in skin colour), open sores, or excessive hair at the application sites
- acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
- history of or current drug or alcohol dependence
- positive alcohol or drug test at screening examination
- regular intake of alcoholic food or beverages of ≥ 24 g pure ethanol for male or ≥ 12 g pure ethanol for female per day
- subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
- regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
- blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the subject
- participation in a clinical trial with administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the subject
- simultaneous participation in another clinical trial with active ingredients
- regular treatment with any systemically available medication (except sexual and thyroid hormones)
- subjects, who report a frequent occurrence of migraine attacks
- positive pregnancy test at screening examination
- pregnant or lactating women
- female subjects who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods)
- subject is vulnerable such as detained or committed to an institution by a court of law or by legal authorities or close affiliation with the sponsor or the investigational site (e.g., a close relative of the investigator, dependent person (e.g., employee of or student at the investigational site), employee of the sponsor or affiliates)
- subject suspected or known not to follow instructions
- subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
SocraTec R&D GmbH Clinical Pharmacology Unit
Mainzerhofplatz 14, Erfurt, 99084
About this study
Official title: Characterization of Relative Bioavailability of a Newly Developed Esflurbiprofen Topical System (EFTS) in Comparison with a Marketed Oral Flurbiprofen-containing Tablet Formulation After Multiple-dose Administration Including EFTS Adhesion Assessment - a Phase I, Open-label, Randomized, 2-period, Cross-over Study in Healthy Subjects
This study is a single-center, open-label, multiple-dose trial performed in a 2-period, 2- sequence-cross-over design in healthy volunteers. The primary purpose of this study is to assess non-superiority of the bioavailability of TK-254RX compared with that of a marketed oral flurbiprofen-containing tablet formulation in healthy volunteers in a 2-period, 2- sequence-cross-over design and evaluate adhesion of TK-254RX. Secondary purpose is to assess safety of TK-254RX and residual amount of the patch.
- Conditions
- Healthy
- Being tested
- Esflurbiprofen Topical System, Flurbiprofen tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esflurbiprofen Topical SystemDrug
The total of two TK-254RX per day for 5 days (one patch applied to left and right lower leg above ankle)
Flurbiprofen tabletDrug
3 tablets per day for 4 days
| Study group | Role | What they receive |
|---|---|---|
| TK-254RX | Experimental | TK-254RX will be applied to left and right lower leg above ankle once daily over 5 consecutive days i.e. 10 patches will be applied totally. Receives: Drug: Esflurbiprofen Topical System |
| Tablet (reference product) | Experimental | Tablets containing 100mg flurbiprofen will be administered three times daily (every 8 h) over 4 consecutive days i.e. 12 tablets will be administered totally. Receives: Drug: Flurbiprofen tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve over 24 hours of S-flurbiprofen for TK-254RX and tablet under steady-state conditions
Measured: Day 5 to Day 6
Peak Plasma Concentration of S-flurbiprofen for TK-254RX and tablet under steady-state conditions
Measured: Day 5 to Day 6
Characterization of patch adhesion
Measuring patch adhesion area by percentage of visually by site staff with remaining patch adhered
Measured: Day 1 to Day 6
Secondary outcomes (34)
Area under the plasma concentration versus time curve over 24 hours of S-flurbiprofen for TK-254RX on Day 1
Measured: Day 1 to Day 2
Peak Plasma Concentration of S-flurbiprofen for TK-254RX on Day 1
Measured: Day 1 to Day 2
Time to reach Peak Plasma Concentration of TK-254RX after the first two patches application on Day 1
Measured: Day 1
Time before first concentration value above the lower limit of quantitation of TK-254RX after the first two patches application on Day 1
Measured: Day 1
Trough concentration of TK-254RX
minimum concentration at the end of each dosing
Measured: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours after first TK-254RX application
Trough concentration of tablet
minimum concentration at the end of each dosing
Measured: 24 hours, 48 hours, 72 hours, 96 hours after first tablet application
Area under the plasma concentration versus time curve of R- flurbiprofen and metabolites from the last two TK-254RX application to the time point of 24 hours under steady condition
Measured: Day 5
Peak Plasma Concentration of R-flurbiprofen and metabolites under steady condition
Measured: Day 5
Minimum plasma concentration of TK-254RX under steady condition
Measured: Day 5
Time to reach Peak Plasma Concentration of TK-254RX under steady condition
Measured: Day 5
Percentage of peak trough fluction of TK-254RX under steady condition
Measured: Day 5
Average concentration at time points on Day 5 under steady condition
Measured: Day 5
Area under the plasma concentration versus time curve from the last two TK-254RX application to last measurement time point with a concentration value above lower limit of quantitation
Measured: Day 5 to Day 8
Percentage of area under the plasma concentration versus time curve extrapolated to infinity to area under the plasma concentration versus time curve from 0 hour to infinity of the last TK-254RX application
Measured: Day 5 to Day 8
Area under the plasma concentration versus time curve from 0 hour to infinity of the last TK-254RX application
Measured: Day 5 to Day 8
Concentration at the last time point with concentration value above the lower limit of quantitation of the last TK-254RX application
Measured: Day 5 to Day 8
Last time point with concentration value above the lower limit of quantitation of the last TK-254RX application
Measured: Day 5 to Day 8
Apparent terminal elimination half-life of TK-254RX
Measured: Day 5 to Day 8
Apparent terminal elimination rate constant determined by log-linear regression of TK-254RX
Measured: Day 5 to Day 8
Area under the plasma concentration versus time curve of R-flurbiprofen and metabolites over 24 hours under steady condition
Measured: Day 4 to Day 7
Peak plasma concentration of R-flurbiprofen and metabolites of tablet under steady condition
Measured: Day 4 to Day 7
Minimum plasma concentration of tablet under steady condition
Measured: Day 4 to Day 7
Time to reach Peak Plasma Concentration of tablet under steady condition
Measured: Day 4 to Day 7
Percentage of peak trough fluction of tablet under steady condition
Measured: Day 4 to Day 7
Average concentration at time points of tablet under steady condition
Measured: Day 4 to Day 7
Area under the plasma concentration versus time curve from the first tablet administration on day 4 to last measurement time point with a concentration value above lower limit of quantitation
Measured: Day 4 to Day 7
Area under the plasma concentration versus time curve from 0 hour to infinity of tablet of administration on 4th day
Measured: Day 4 to Day 7
Percentage of area under the plasma concentration versus time curve extrapolated to infinity to area under the plasma concentration versus time curve from 0 hour to infinity of tablet of administration on 4th day
Measured: Day 4 to Day 7
Concentration at the last time point with concentration value above the lower limit of quantitation of tablet of administration on 4th day
Measured: Day 4 to Day 7
Last time point with concentration value above the lower limit of quantitation of tablet of administration on 4th day
Measured: Day 4 to Day 7
Apparent terminal elimination half-life of tablet
Measured: Day 4 to Day 7
Apparent terminal elimination rate constant determined by log-linear regression of tablet
Measured: Day 4 to Day 7
Local tolerability
Assessing the local tolerability by using the 8-point dermal response and other effects score according to FDA recommendation
Measured: within 5 min after removal of each patch as well as 12 h, 24 h, and 36 h after removal of the last 2 patches on study Day 6
Residual amount of S-flurbiprofen
residual amount of S-flurbiprofen in used patch applied on Day 5
Measured: Day 5 to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start21 Jan 2025
- Primary completion12 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teikoku Seiyaku Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SocraTec R&D GmbH, SocraMetrics GmbH, HWI pharma services GmbH
- Responsible party
- Sponsor
- Investigators
- Kenichi Nishiyama, Study chair, Teikoku Seiyaku Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823284
- Sponsor's protocol ID
- TK-254RX-0102
- Other IDs
- 2024-513058-31-00
- Status last verified
- Mar 2025
- First submitted
- 19 Jan 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Relative Bioavailability of a Newly Developed Esflurbiprofen Topical System (EFTS) in Comparison with a Marketed Oral Flurbiprofen-containing Tablet Formulation After Multiple-dose Administration Including EFTS Adhesion Assessment - a Phase I, Open-label, Randomized, 2-period, Cross-over Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06823284
- Acronym / sponsor ID
- TK-254RX-0102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Teikoku Seiyaku Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- SocraTec R&D GmbH, SocraMetrics GmbH, HWI pharma services GmbH
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, open-label, multiple-dose trial performed in a 2-period, 2- sequence-cross-over design in healthy volunteers. The primary purpose of this study is to assess non-superiority of the bioavailability of TK-254RX compared with that of a marketed oral flurbiprofen-containing tablet formulation in healthy volunteers in a 2-period, 2- sequence-cross-over design and evaluate adhesion of TK-254RX. Secondary purpose is to assess safety of TK-254RX and residual amount of the patch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TK-254RX | Experimental | Drug: Esflurbiprofen Topical SystemTK-254RX will be applied to left and right lower leg above ankle once daily over 5 consecutive days i.e. 10 patches will be applied totally. |
| Tablet (reference product) | Experimental | Drug: Flurbiprofen tabletTablets containing 100mg flurbiprofen will be administered three times daily (every 8 h) over 4 consecutive days i.e. 12 tablets will be administered totally. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age: 18 years to 64 years (inclusive)
- body-mass index (BMI): ≥18.5 kg/m² and ≤ 30.0 kg/m²
- good state of health
- non-smoker or ex-smoker for at least 3 months
- written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical triall
Key exclusion criteria (42 listed)
- existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- existing or history of hypertension and/or heart failure
- existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- history of gastrointestinal bleeding or perforation related to previous NSAID therapy
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 |
|---|---|---|
| Esflurbiprofen Topical SystemThe total of two TK-254RX per day for 5 days (one patch applied to left and right lower leg above ankle) | Drug | TK-254RX |
| Flurbiprofen tablet3 tablets per day for 4 days | Drug | Tablet (reference product) |
Primary outcome
Area under the plasma concentration versus time curve over 24 hours of S-flurbiprofen for TK-254RX and tablet under steady-state conditions
Time frame: Day 5 to Day 6
Peak Plasma Concentration of S-flurbiprofen for TK-254RX and tablet under steady-state conditions
Time frame: Day 5 to Day 6
Characterization of patch adhesion
Time frame: Day 1 to Day 6
Measuring patch adhesion area by percentage of visually by site staff with remaining patch adhered
34 secondary outcomes
Area under the plasma concentration versus time curve over 24 hours of S-flurbiprofen for TK-254RX on Day 1
Time frame: Day 1 to Day 2
Peak Plasma Concentration of S-flurbiprofen for TK-254RX on Day 1
Time frame: Day 1 to Day 2
Time to reach Peak Plasma Concentration of TK-254RX after the first two patches application on Day 1
Time frame: Day 1
Time before first concentration value above the lower limit of quantitation of TK-254RX after the first two patches application on Day 1
Time frame: Day 1
Trough concentration of TK-254RX
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours after first TK-254RX application
Trough concentration of tablet
Time frame: 24 hours, 48 hours, 72 hours, 96 hours after first tablet application
Area under the plasma concentration versus time curve of R- flurbiprofen and metabolites from the last two TK-254RX application to the time point of 24 hours under steady condition
Time frame: Day 5
Peak Plasma Concentration of R-flurbiprofen and metabolites under steady condition
Time frame: Day 5
Minimum plasma concentration of TK-254RX under steady condition
Time frame: Day 5
Time to reach Peak Plasma Concentration of TK-254RX under steady condition
Time frame: Day 5
Percentage of peak trough fluction of TK-254RX under steady condition
Time frame: Day 5
Average concentration at time points on Day 5 under steady condition
Time frame: Day 5
Area under the plasma concentration versus time curve from the last two TK-254RX application to last measurement time point with a concentration value above lower limit of quantitation
Time frame: Day 5 to Day 8
Percentage of area under the plasma concentration versus time curve extrapolated to infinity to area under the plasma concentration versus time curve from 0 hour to infinity of the last TK-254RX application
Time frame: Day 5 to Day 8
Area under the plasma concentration versus time curve from 0 hour to infinity of the last TK-254RX application
Time frame: Day 5 to Day 8
Concentration at the last time point with concentration value above the lower limit of quantitation of the last TK-254RX application
Time frame: Day 5 to Day 8
Last time point with concentration value above the lower limit of quantitation of the last TK-254RX application
Time frame: Day 5 to Day 8
Apparent terminal elimination half-life of TK-254RX
Time frame: Day 5 to Day 8
Apparent terminal elimination rate constant determined by log-linear regression of TK-254RX
Time frame: Day 5 to Day 8
Area under the plasma concentration versus time curve of R-flurbiprofen and metabolites over 24 hours under steady condition
Time frame: Day 4 to Day 7
Peak plasma concentration of R-flurbiprofen and metabolites of tablet under steady condition
Time frame: Day 4 to Day 7
Minimum plasma concentration of tablet under steady condition
Time frame: Day 4 to Day 7
Time to reach Peak Plasma Concentration of tablet under steady condition
Time frame: Day 4 to Day 7
Percentage of peak trough fluction of tablet under steady condition
Time frame: Day 4 to Day 7
Average concentration at time points of tablet under steady condition
Time frame: Day 4 to Day 7
Area under the plasma concentration versus time curve from the first tablet administration on day 4 to last measurement time point with a concentration value above lower limit of quantitation
Time frame: Day 4 to Day 7
Area under the plasma concentration versus time curve from 0 hour to infinity of tablet of administration on 4th day
Time frame: Day 4 to Day 7
Percentage of area under the plasma concentration versus time curve extrapolated to infinity to area under the plasma concentration versus time curve from 0 hour to infinity of tablet of administration on 4th day
Time frame: Day 4 to Day 7
Concentration at the last time point with concentration value above the lower limit of quantitation of tablet of administration on 4th day
Time frame: Day 4 to Day 7
Last time point with concentration value above the lower limit of quantitation of tablet of administration on 4th day
Time frame: Day 4 to Day 7
Apparent terminal elimination half-life of tablet
Time frame: Day 4 to Day 7
Apparent terminal elimination rate constant determined by log-linear regression of tablet
Time frame: Day 4 to Day 7
Local tolerability
Time frame: within 5 min after removal of each patch as well as 12 h, 24 h, and 36 h after removal of the last 2 patches on study Day 6
Residual amount of S-flurbiprofen
Time frame: Day 5 to Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Kenichi Nishiyama study chair
Teikoku Seiyaku Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Esflurbiprofen Topical System and Flurbiprofen tablet in people with Healthy, run by Teikoku Seiyaku Co., Ltd. at 1 site in Germany.
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 5 inclusion and 42 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 11 Mar 2025. 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 Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the plasma concentration versus time curve over 24 hours of S-flurbiprofen for TK-254RX and tablet under steady-state conditions (time frame: Day 5 to Day 6). The study lists 3 primary outcomes in all. 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 11 Mar 2025.