PainPhase 4NCT04307940

Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed

A Phase 4 study testing Naproxen Sodium (Aleve, BAY117031) and Hydrocodone/Acetaminophen in people with Pain, run by Bayer at 1 site in United States.

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

With this study researchers want to collect information on how long the pain relief lasts after a fixed dose of naproxen sodium or hydrocodone/acetaminophen or placebo (contains no medication) over 12 hours in subjects experiencing moderate to severe pain after having their wisdom teeth removed. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Pain
What is being tested?: Naproxen Sodium (Aleve, BAY117031) and Hydrocodone/Acetaminophen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 221 participants
Where: 1 siteUnited States
Study dates: 12 Mar 2020to 5 Oct 2020
Phase: Phase 4
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 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Healthy, ambulatory, male or female volunteers 18 to 40 years of age;
Subjects will undergo surgical extraction of three or four third molars, two of which must be mandibular molars. Maxillary third molars may be removed regardless of impaction level. The mandibular extractions must have a trauma rating of mild or moderate and meet one of the following scenarios:
two full bony impactions
two partial bony impactions
one full bony impaction in combination with one partial bony impaction Supernumerary teeth present may also be removed at the discretion of the oral surgeon;
Have not consumed alcoholic beverages, or foods and beverages containing caffeine (examples; coffee, tea, chocolate, and colas) after midnight prior to surgery and agree not to consume any of these foods or beverages throughout their stay at the study site;

Show all 10Show fewer

Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine) preoperatively, with or without a vasoconstrictor and nitrous oxide at the discretion of the Investigator;
Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of ≥ 5 on the 0-10 pain intensity NRS within 4.5 hours postsurgery;
Ability to understand and follow study-related instructions;
Be willing and able to participate in all scheduled visits, treatment plan, and trial procedures according to the clinical protocol;

Who cannot join

History of hypersensitivity to naproxen sodium, hydrocodone/acetaminophen, ibuprofen, NSAIDS, aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension), hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
Subjects with the following medical conditions may be eligible at the discretion of the investigator: ADHD on a stable dose regimen of methylphenidate/(dextro)amphetamine for at least 6 months; subjects with hypothyroidism on a stable dose of synthetic thyroid hormone for at least 6 months;
Have received any form of treatment in the form of medication for depression in the past 6 months or any form of psychotropic agent (including selective serotonin uptake inhibitors [SSRI] but excluding ADHD medications described above) within the last 6 months;
Use of any OTC or prescription medications with which the administration of naproxen, hydrocodone/acetaminophen, acetaminophen, ibuprofen, any other NSAID, (e.g., tramadol) or if a medication is contraindicated;
Females who are planning to become pregnant, pregnant or lactating;

Show all 10Show fewer

Habituation to analgesic drugs including opioids (i.e., routine use of oral analgesics 5 or more times per week for greater than 3 weeks within the past 2 years);
Alcoholism or drug abuse within 2 years prior to the Screening Visit or routine consumption of 3 or more alcohol containing beverages per day; Alcohol containing beverages are defined as one beer (5%), one glass of wine (11%) and one shot (40%) hard liquor;
Surgeon's trauma rating of severe following surgery;
Unwilling or unable to comply with all requirements outlined in the protocol;

Trial locations and contacts

1 site in 1 country.

United States1 site

JBR Clinical Research
Salt Lake City, Utah, 84107

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain

Hydrocodone/Acetaminophen is a combination drug used to relieve moderate to severe pain. It contains an opioid (narcotic) pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).

Conditions: Pain
Being tested: Naproxen Sodium (Aleve, BAY117031), Hydrocodone/Acetaminophen, Placebo
Keywords: Postsurgical Dental Pain
Medical subject headings: Pain

What participants receive

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

Naproxen Sodium (Aleve, BAY117031)Drug
220 mg per tablet, two tablets (440 mg), intake a single dose orally.
Hydrocodone/AcetaminophenDrug
5/325 mg per tablet, two tablets (10/650 mg), intake a single dose orally.
PlaceboDrug
two tablets, intake a single dose orally.

Study groups in NCT04307940
Study group	Role	What they receive
Naproxen sodium	Experimental	After completion of the surgical teeth extractions, qualified participants will be randomized into one of three treatments with a 2:2:1 ratio. (Naproxen sodium=2, Hydrocodone/Acetaminophen=2, Placebo=1) Receives: Drug: Naproxen Sodium (Aleve, BAY117031)
Hydrocodone/Acetaminophen	Active comparator	After completion of the surgical teeth extractions, qualified participants will be randomized into one of three treatments with a 2:2:1 ratio. (Naproxen sodium=2, Hydrocodone/Acetaminophen=2, Placebo=1) Receives: Drug: Hydrocodone/Acetaminophen
Placebo	Placebo comparator	After completion of the surgical teeth extractions, qualified participants will be randomized into one of three treatments with a 2:2:1 ratio. (Naproxen sodium=2, Hydrocodone/Acetaminophen=2, Placebo=1) Receives: Drug: Placebo

What is being measured

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

Sum of Pain Intensity Difference Over 12 Hours (SPID 0-12)
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 12 hours ranges from -120 to 120. A higher value indicates a better pain reduction.
Measured: Up to 12 hours postdose

Secondary outcomes (8)

Total Pain Relief Over 12 Hours (TOTPAR 0-12)
Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 12 hours ranges from 0 to 48, a higher value indicates more pain relief.
Measured: Up to 12 hours postdose
Total Pain Relief Over 6 Hours (TOTPAR 0-6)
Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 6 hours ranges from 0 to 24, a higher value indicates more pain relief.
Measured: Up to 6 hours postdose
Sum of Pain Intensity Difference Over 6 Hours (SPID 0-6)
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 6 hours ranges from -60 to 60. A higher value indicates a better pain reduction.
Measured: Up to 6 hours postdose
Number of Participants Required or Did Not Reqiure Rescue Pain Medication
Measured: Up to 12 hours postdose
Amount of Rescue Medication
To quantify the use of opioid analgesics in treatment of post-operative dental pain, the amount of rescue medications (opioids) was converted to a standard unit, which was Morphine Milligram Equivalent (MME) using below formula:
MME/Day = Strength per Unit × (Number of units / Days supply) × MME conversion factor
Measured: Up to 12 hours postdose
Time to First Use of Rescue Medication
If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.
Measured: Up to 12 hours postdose
Duration of Pain at Least Half Gone Over 12 Hours
Measured: Up to 12 hours postdose
Duration of Pain at Least Half Gone Over 6 Hours
Measured: Up to 6 hours postdose

Timeline

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

12 Mar 20205 Oct 2020

First posted13 Mar 2020
Study start12 Mar 2020
Primary completion2 Oct 2020
Study completion5 Oct 2020

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 PainStudies of the same condition, open and under way.
More trials run by BayerThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04307940
Sponsor's protocol ID: 20536
Status last verified: Jul 2022
First submitted: 5 Mar 2020
Last updated: 14 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

Cooper SA, Desjardins PJ, Bertoch T, Paredes-Diaz A, Troullos E, Tajaddini A, Centofanti R, An R, Morella D. Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial. Postgrad Med. 2022 Jun;134(5):463-470. doi: 10.1080/00325481.2021.2008180. Epub 2021 Dec 8.
PubMed 34878953

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain
ClinicalTrials.gov ID: NCT04307940
Acronym / sponsor ID: 20536
Conditions: Pain
Keywords: Postsurgical Dental Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 12 Mar 2020 (actual)
Primary completion: 2 Oct 2020 (actual)
Study completion: 5 Oct 2020 (actual)
First posted: 13 Mar 2020 (actual)
Results: Posted 7 Oct 2021

Clinical summary

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

Hydrocodone/Acetaminophen is a combination drug used to relieve moderate to severe pain. It contains an opioid (narcotic) pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).

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
Naproxen sodium	Experimental	Drug: Naproxen Sodium (Aleve, BAY117031)After completion of the surgical teeth extractions, qualified participants will be randomized into one of three treatments with a 2:2:1 ratio. (Naproxen sodium=2, Hydrocodone/Acetaminophen=2, Placebo=1)
Hydrocodone/Acetaminophen	Active comparator	Drug: Hydrocodone/AcetaminophenAfter completion of the surgical teeth extractions, qualified participants will be randomized into one of three treatments with a 2:2:1 ratio. (Naproxen sodium=2, Hydrocodone/Acetaminophen=2, Placebo=1)
Placebo	Placebo comparator	Drug: PlaceboAfter completion of the surgical teeth extractions, qualified participants will be randomized into one of three treatments with a 2:2:1 ratio. (Naproxen sodium=2, Hydrocodone/Acetaminophen=2, Placebo=1)

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy, ambulatory, male or female volunteers 18 to 40 years of age;
Subjects will undergo surgical extraction of three or four third molars, two of which must be mandibular molars. Maxillary third molars may be removed regardless of impaction level. The mandibular extractions must have a trauma rating of mild or moderate and meet one of the following scenarios:
Have not consumed alcoholic beverages, or foods and beverages containing caffeine (examples; coffee, tea, chocolate, and colas) after midnight prior to surgery and agree not to consume any of these foods or beverages throughout their stay at the study site;
Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine) preoperatively, with or without a vasoconstrictor and nitrous oxide at the discretion of the Investigator;
Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of ≥ 5 on the 0-10 pain intensity NRS within 4.5 hours postsurgery;

Key exclusion criteria (10 listed)

History of hypersensitivity to naproxen sodium, hydrocodone/acetaminophen, ibuprofen, NSAIDS, aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension), hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
Subjects with the following medical conditions may be eligible at the discretion of the investigator: ADHD on a stable dose regimen of methylphenidate/(dextro)amphetamine for at least 6 months; subjects with hypothyroidism on a stable dose of synthetic thyroid hormone for at least 6 months;
Have received any form of treatment in the form of medication for depression in the past 6 months or any form of psychotropic agent (including selective serotonin uptake inhibitors [SSRI] but excluding ADHD medications described above) within the last 6 months;
Use of any OTC or prescription medications with which the administration of naproxen, hydrocodone/acetaminophen, acetaminophen, ibuprofen, any other NSAID, (e.g., tramadol) or if a medication is contraindicated;

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
Naproxen Sodium (Aleve, BAY117031)220 mg per tablet, two tablets (440 mg), intake a single dose orally.	Drug	Naproxen sodium
Hydrocodone/Acetaminophen5/325 mg per tablet, two tablets (10/650 mg), intake a single dose orally.	Drug	Hydrocodone/Acetaminophen
Placebotwo tablets, intake a single dose orally.	Drug	Placebo

Primary outcome

Sum of Pain Intensity Difference Over 12 Hours (SPID 0-12)
Time frame: Up to 12 hours postdose
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 12 hours ranges from -120 to 120. A higher value indicates a better pain reduction.

8 secondary outcomes

Total Pain Relief Over 12 Hours (TOTPAR 0-12)
Time frame: Up to 12 hours postdose
Total Pain Relief Over 6 Hours (TOTPAR 0-6)
Time frame: Up to 6 hours postdose
Sum of Pain Intensity Difference Over 6 Hours (SPID 0-6)
Time frame: Up to 6 hours postdose
Number of Participants Required or Did Not Reqiure Rescue Pain Medication
Time frame: Up to 12 hours postdose
Amount of Rescue Medication
Time frame: Up to 12 hours postdose
Time to First Use of Rescue Medication
Time frame: Up to 12 hours postdose
Duration of Pain at Least Half Gone Over 12 Hours
Time frame: Up to 12 hours postdose
Duration of Pain at Least Half Gone Over 6 Hours
Time frame: Up to 6 hours postdose

Results and safety

Results posted to the registry on 7 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Naproxen Sodium	90	85
Hydrocodone / APAP	87	84
Placebo	44	42

Primary outcome: Sum of Pain Intensity Difference Over 12 Hours (SPID 0-12)

Time frame: Up to 12 hours postdose. Least squares mean (Standard Error). Unit: Scores on a scale*hours

Measure	Naproxen Sodium n = 86	Hydrocodone / APAP n = 83	Placebo n = 43
Value	53.20 (3.09)	38.39 (3.14)	13.57 (4.35)

Naproxen Sodium vs Hydrocodone / APAP: LS Mean Difference: 14.81 (95% CI 6.10 to 23.51), p = 0.001, ANCOVA
Naproxen Sodium vs Placebo: LS Mean Difference: 39.63 (95% CI 29.08 to 50.18), p <0.001, ANCOVA
Hydrocodone / APAP vs Placebo: LS Mean Difference: 24.82 (95% CI 14.26 to 35.39), p <0.001, ANCOVA

Population analysed: PP Population: all subjects in safety population who provided at least one pain assessment after the first dose of study drug and did not have any major protocol violations and completed the 12-hour assessments.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of the study drug administration until end of study treatment, up to 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naproxen Sodium	0 of 90 (0%)	2 of 90 (2.2%)	0 of 90
Hydrocodone/APAP	0 of 87 (0%)	33 of 87 (37.9%)	0 of 87
Placebo	0 of 44 (0%)	11 of 44 (25%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34878953Cooper SA, Desjardins PJ, Bertoch T, Paredes-Diaz A, Troullos E, Tajaddini A, Centofanti R, An R, Morella D. Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial. Postgrad Med. 2022 Jun;134(5):463-470. doi: 10.1080/00325481.2021.2008180. Epub 2021 Dec 8.
Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Naproxen Sodium (Aleve, BAY117031) and Hydrocodone/Acetaminophen in people with Pain, run by Bayer 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 10 inclusion and 10 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 14 Jul 2022. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 7 Oct 2021). 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?

Sum of Pain Intensity Difference Over 12 Hours (SPID 0-12) (time frame: Up to 12 hours postdose). 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 NCT04307940, 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 14 Jul 2022.