Rhinitis, AllergicPhase 3NCT03855228

Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

A Phase 3 study testing Mometasone furoate nasal spray (MFNS) and Loratadine in people with Rhinitis, Allergic, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Rhinitis, Allergic
What is being tested?: Mometasone furoate nasal spray (MFNS) and Loratadine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 704 participants
Where: No sites listed yet
Study dates: 1 Mar 1995to 7 Aug 1995
Phase: Phase 3
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

2-year history of seasonal allergic rhinitis
Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Who cannot join

Women who are pregnant or breastfeeding
Women of childbearing potential who are not using an acceptable form of birth control
Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study
Use of any chronic medication which could affect the course of seasonal allergic rhinitis
Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment)
Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip

Show all 15Show fewer

Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening
Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
Has rhinitis medicamentosa
Evidence of clinically significant nasal candidiasis
Investigational drug use within the previous 30 days
Nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the Screening visit
History of multiple drug allergies, allergy to antihistamines or corticoids
History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study

About this study

Official title: Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in the Treatment of Seasonal Allergic Rhinitis (Study No. C94-145)

Conditions: Rhinitis, Allergic
Being tested: Mometasone furoate nasal spray (MFNS), Loratadine, Placebo nasal spray, Placebo tablet
Medical subject headings: Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mometasone furoate nasal spray (MFNS)Drug
Also called SCH 32088, MK-0887, NASONEX®
Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.
LoratadineDrug
Also called Claritin®
Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.
Placebo nasal sprayDrug
Daily dose of placebo administered as a nasal spray for 15 days.
Placebo tabletDrug
Daily dose of placebo administered as an oral tablet for 15 days.

Study groups in NCT03855228
Study group	Role	What they receive
MFNS 200 µg + Loratadine 10 mg	Experimental	Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet. Receives: Drug: Mometasone furoate nasal spray (MFNS); Drug: Loratadine
MFNS 200 µg	Active comparator	Daily administration of 200 µg of MFNS plus oral placebo tablet. Receives: Drug: Mometasone furoate nasal spray (MFNS); Drug: Placebo tablet
Loratadine 10 mg	Active comparator	Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray. Receives: Drug: Loratadine; Drug: Placebo nasal spray
Placebo	Placebo comparator	Daily administration of placebo nasal spray plus oral placebo tablet. Receives: Drug: Placebo nasal spray; Drug: Placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB.
CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
Measured: Baseline and days 1 through 15 (average of 15 days of treatment)
Change From Baseline in Total Symptom Score (Assessed by Participant)
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB.
CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
Measured: Baseline and days 1 through 15 (average of 15 days of treatment)

Secondary outcomes (8)

Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)
The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity.
A negative change from baseline indicates a decrease in symptom severity.
Measured: Baseline and study day 15
Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)
The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity.
A negative change from baseline indicates a decrease in symptom severity.
Measured: Baseline and study day 15
Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)
The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity.
A negative change from baseline indicates a decrease in symptom severity.
Measured: Baseline and study day 8
Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)
The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity.
A negative change from baseline indicates a decrease in symptom severity.
Measured: Baseline and study day 8
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)
The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity.
A negative change from baseline indicates a decrease in symptom severity.
Measured: Baseline and study day 15
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician)
The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity.
A negative change from baseline indicates a decrease in symptom severity.
Measured: Baseline and study day 8
Response to Therapy on Day 15 (Assessed by Physician)
Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response.
Measured: Study day 15
Response to Therapy on Day 8 (Assessed by Physician)
Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response.
Measured: Study day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 19957 Aug 1995

First posted26 Feb 2019
Study start1 Mar 1995
Primary completion7 Aug 1995
Study completion7 Aug 1995

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 Rhinitis, AllergicStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 704 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03855228
Sponsor's protocol ID: C94-145
Other IDs: C94-145
Status last verified: Feb 2022
First submitted: 25 Feb 2019
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Enrolling by invitationObservational study
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All Rhinitis, Allergic trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in the Treatment of Seasonal Allergic Rhinitis (Study No. C94-145)
ClinicalTrials.gov ID: NCT03855228
Acronym / sponsor ID: C94-145
Conditions: Rhinitis, Allergic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 704 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 1 Mar 1995 (actual)
Primary completion: 7 Aug 1995 (actual)
Study completion: 7 Aug 1995 (actual)
First posted: 26 Feb 2019 (actual)
Results: Posted 26 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
MFNS 200 µg + Loratadine 10 mg	Experimental	Drug: Mometasone furoate nasal spray (MFNS), Drug: LoratadineDaily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet.
MFNS 200 µg	Active comparator	Drug: Mometasone furoate nasal spray (MFNS), Drug: Placebo tabletDaily administration of 200 µg of MFNS plus oral placebo tablet.
Loratadine 10 mg	Active comparator	Drug: Loratadine, Drug: Placebo nasal sprayDaily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Placebo	Placebo comparator	Drug: Placebo nasal spray, Drug: Placebo tabletDaily administration of placebo nasal spray plus oral placebo tablet.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

2-year history of seasonal allergic rhinitis
Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Key exclusion criteria (15 listed)

Women who are pregnant or breastfeeding
Women of childbearing potential who are not using an acceptable form of birth control
Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study
Use of any chronic medication which could affect the course of seasonal allergic rhinitis
Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment)

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
Mometasone furoate nasal spray (MFNS)Also: SCH 32088, MK-0887, NASONEX®Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.	Drug	MFNS 200 µg, MFNS 200 µg + Loratadine 10 mg
LoratadineAlso: Claritin®Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.	Drug	Loratadine 10 mg, MFNS 200 µg + Loratadine 10 mg
Placebo nasal sprayDaily dose of placebo administered as a nasal spray for 15 days.	Drug	Loratadine 10 mg, Placebo
Placebo tabletDaily dose of placebo administered as an oral tablet for 15 days.	Drug	MFNS 200 µg, Placebo

Primary outcome

Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)
Time frame: Baseline and days 1 through 15 (average of 15 days of treatment)
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
Change From Baseline in Total Symptom Score (Assessed by Participant)
Time frame: Baseline and days 1 through 15 (average of 15 days of treatment)
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.

8 secondary outcomes

Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)
Time frame: Baseline and study day 15
Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)
Time frame: Baseline and study day 15
Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)
Time frame: Baseline and study day 8
Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)
Time frame: Baseline and study day 8
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)
Time frame: Baseline and study day 15
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician)
Time frame: Baseline and study day 8
Response to Therapy on Day 15 (Assessed by Physician)
Time frame: Study day 15
Response to Therapy on Day 8 (Assessed by Physician)
Time frame: Study day 8

Results and safety

Results posted to the registry on 26 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MFNS 200 μg + Loratadine 10 mg	169	166
MFNS 200 μg	176	167
Loratadine 10 mg	182	174
Placebo	177	158

Primary outcome: Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)

Time frame: Baseline and days 1 through 15 (average of 15 days of treatment). Mean (Standard Deviation). Unit: Score on a scale

Measure	MFNS 200 μg + Loratadine 10 mg n = 165	MFNS 200 μg n = 166	Loratadine 10 mg n = 175	Placebo n = 165
Baseline	7.9 (2.2)	7.8 (2.2)	7.9 (2.2)	8.0 (2.1)
Change From Baseline Days 1-15	-3.0 (2.6)	-2.7 (2.5)	-1.9 (2.2)	-1.4 (2.2)

MFNS 200 μg + Loratadine 10 mg vs MFNS 200 μg: p = 0.36, ANOVA
MFNS 200 μg + Loratadine 10 mg vs Loratadine 10 mg: p <0.01, ANOVA
MFNS 200 μg + Loratadine 10 mg vs Placebo: p <0.01, ANOVA

Population analysed: Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average.

Primary outcome: Change From Baseline in Total Symptom Score (Assessed by Participant)

Time frame: Baseline and days 1 through 15 (average of 15 days of treatment). Mean (Standard Deviation). Unit: Score on a scale

Measure	MFNS 200 μg + Loratadine 10 mg n = 165	MFNS 200 μg n = 166	Loratadine 10 mg n = 175	Placebo n = 165
Baseline	14.3 (4.1)	14.2 (4.4)	14.4 (4.5)	14.6 (4.3)
Change From Baseline Days 1-15	-5.4 (4.8)	-4.8 (4.7)	-3.8 (4.2)	-2.7 (4.2)

MFNS 200 μg + Loratadine 10 mg vs MFNS 200 μg: p = 0.35, ANOVA
MFNS 200 μg + Loratadine 10 mg vs Loratadine 10 mg: p <0.01, ANOVA
MFNS 200 μg + Loratadine 10 mg vs Placebo: p <0.01, ANOVA

Population analysed: Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 45 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MFNS Pus Loratadine	0 of 169 (0%)	22 of 169 (13%)	0 of 169
MFNS 200	0 of 176 (0%)	22 of 176 (12.5%)	0 of 176
Loratadine	0 of 181 (0%)	33 of 181 (18.2%)	0 of 181
Placebo	0 of 176 (0%)	21 of 176 (11.9%)	0 of 176

Limitations and caveats (from the sponsor): AE Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 12.0.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rhinitis, Allergic

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mometasone furoate nasal spray (MFNS) and Loratadine in people with Rhinitis, Allergic, run by Organon and Co.

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 3 inclusion and 15 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2019). 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 Total Nasal Symptom Score (Assessed by Participant) (time frame: Baseline and days 1 through 15 (average of 15 days of treatment)). The study lists 2 primary outcomes in all. 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 NCT03855228.

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 9 Feb 2022.