Neuropathic PainPhase 1/2NCT04603066

Tariquidar-ondansetron Combination in Neuropathic Pain

A Phase 1/2 study testing Ondansetron 16 mg with Tariquidar in people with Neuropathic Pain, run by Washington University School of Medicine 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

Search all trials

Trial summary

Prospective, randomized, double-blind, placebo controlled, cross-over proof of concept study. To determine the pharmacokinetics and tolerability of co-administration of 5-HT3R antagonist ondansetron with a P-glycoprotein inhibitor tariquidar, in patients with neuropathic pain. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Neuropathic Pain
What is being tested?: Ondansetron 16 mg with Tariquidar
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 31 Jan 2021to 3 Nov 2023
Phase: Phase 1/2
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-65;
Documented diagnosis of neuropathic pain due to damage or disease affecting the peripheral nervous system;
At least Probable neuropathic pain grading1;
Pain duration >3 months;
Average pain intensity ≥4 on 0-10 numerical rating scale (NRS).

Who cannot join

Current pregnancy or lactation;
Moderate-severe kidney or liver dysfunction;
Active cardiac arrhythmias (non-sinus rhythm), Long QT syndrome, or QTc interval >450msec;
Congestive heart failure
Abnormal troponin values at screening visit;
Current treatment with MAO inhibitors, mirtazapine, SSRI antidepressants, or SNRI medications duloxetine or venlafaxine;

Show all 12Show fewer

Current treatment with tapentadol, tramadol, or fentanyl;
Current treatment with P-glycoprotein substrate drugs with narrow therapeutic window, e.g. digoxin;
Current treatment with tricyclic antidepressant medications (e.g. amitriptyline, desipramine, imipramine) at a dose >25mg/day;
Ongoing use of any of the following medications with known effects on Pgp function: carbamazepine, phenytoin, phenobarbital, cyclosporine, clarithromycin, erythromycin, ritonavir, verapamil, rifampicin, St. John's wort;
Current treatment with QT-prolonging drugs, and drugs known to have a significant interaction with ondansetron or other P-glycoprotein substrates (see section 2.3.3.);
Current treatment with anticoagulant drugs;

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Administration of Ondansetron With P-glycoprotein Inhibitor Tariquidar in Patients With Neuropathic Pain

Prospective, randomized, double-blind, placebo controlled, cross-over proof of concept study.

To determine the pharmacokinetics and tolerability of co-administration of 5-HT3R antagonist ondansetron with a P-glycoprotein inhibitor tariquidar, in patients with neuropathic pain.

Read the detailed description

The investigators hypothesize that co-administration of a 5-HT3 receptor antagonist ondansetron (single 16mg dose) with p-glycoprotein inhibitor tariquidar (single 4mg/kg dose) vs placebo in a cross-over prospective randomized study, will:

Be tolerable in patients with neuropathic pain.
Increase the cerebrospinal fluid (CSF) to plasma ratio of ondansetron after intravenous administration, compare to ondansetron alone
Result in a greater reduction in pain intensity than with ondansetron alone.

Conditions: Neuropathic Pain
Being tested: Ondansetron 16 mg with Tariquidar, Ondansetron 16 mg with Placebo
Medical subject headings: Neuralgia

What participants receive

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

Ondansetron 16 mg with TariquidarDrug
Also called Ondansetron/Tariquidar
In randomized order, each participant will receive two IV infusions of ondansetron, 3 weeks apart; one with placebo (D5W), and one with tariquidar (4mg/kg dose in D5W) administered IV over 60 minutes. Ondansetron will be diluted in 100mL 0.9% normal saline, and tariquidar will be diluted in 500mL D5W.
Ondansetron 16 mg with PlaceboDrug
Also called Ondansetron/ Placebo
In randomized order, each participant will receive two IV infusions of ondansetron, 3 weeks apart; one with placebo (D5W), and one with tariquidar (4mg/kg dose in D5W) administered IV over 60 minutes. Ondansetron will be diluted in 100mL 0.9% normal saline, and tariquidar will be diluted in 500mL D5W.

Study groups in NCT04603066
Study group	Role	What they receive
Ondansetron/Placebo first, then Ondansetron/Tariquidar	Other	The study group where patients received Ondansetron with Placebo during Visit 1, and after a washout period of 3 weeks Ondansetron with Tariquidar at Visit 2 per the randomization schedule. Ondansetron 16 mg was administered IV over 60 minutes with placebo (D5W) or with tariquidar (4mg/kg dose in D5W). Ondansetron was diluted in 100mL 0.9% normal saline, and tariquidar was diluted in 500mL D5W. Receives: Drug: Ondansetron 16 mg with Tariquidar; Drug: Ondansetron 16 mg with Placebo
Ondansetron/Tariquidar first, then Ondansetron/Placebo	Other	The study group where patients received Ondansetron with Tariquidar during Visit 1, and after 3 weeks of washout period Ondansetron with Placebo at Visit 2 per the randomization schedule. Ondansetron 16 mg was administered IV over 60 minutes with tariquidar (4mg/kg dose in D5W) or with placebo (D5W). Ondansetron was diluted in 100mL 0.9% normal saline, and tariquidar was diluted in 500mL D5W. Receives: Drug: Ondansetron 16 mg with Tariquidar; Drug: Ondansetron 16 mg with Placebo

What is being measured

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

Concertation-time Profile of Ondansetron in Plasma, Measured by the Area Under the Concentration-time Curve (AUC)
AUCinf for Ondansetron concentration in plasma based on venous blood sampling for plasma concentrations of ondansetron obtained at 0, 15, 30, 60, 90, 120, 180, and 240 minutes from the beginning of ondansetron infusion.
Measured: Measurements over 240 minutes, extrapolated to infinity
Cerebrospinal Fluid to Plasma Concentration Ratio of Ondansetron
The level of ondansetron in plasma and CSF (cerebrospinal fluid) in samples, taken around the same time, was measured, and the ratio of the two values was calculated. This ratio (partition coefficient, Kp) of ondansetron, compared between the two sessions, with placebo vs tariquidar
Measured: anytime between 0-240 minutes

Secondary outcomes (4)

% Change in Pain Intensity
Change in spontaneous pain intensity (measured on a 0-10 numerical rating scale; 0=no pain, 10=worst imaginable pain) from baseline to 90 minutes after ondansetron IV infusion, compared between two sessions with and without tariquidar. Values are presented as a percentage change from baseline.
Measured: baseline to 90 minutes after ondansetron IV infusion
Conditioned Pain Modulation (CPM) Magnitude (ΔCPM)
Conditioned Pain Modulation (CPM) is a psychophysical test to assess the efficiency of descending pain inhibition. CPM is calculated as difference in heat pain threshold with and without pain conditioning - i.e. immersion of a hand in cold water. Conditioned Pain Modulation (CPM) Negative CPM values represent efficient pain modulation/inhibition.
This test was administered at baseline, and again 90-min after the end of ondansetron infusion. CPM values can range from -100 to 100, CPM<0 (i.e. decreased pain to heat stimulus following conditioning) implies descending pain inhibition.
CPM Magnitude (ΔCPM) is the calculated by subtracting the measurement of CPM at baseline [possible range of CPM scores 0-100] from the measurement of CPM 90 min after the intervention [possible range of CPM scores 0-100]. A larger negative ΔCPM value indicates increased pain modulation efficiency following treatment, and therefore, a desired outcome.
Measured: Baseline and 90 minutes after the end of ondansetron infusion
Correlation Between CPM Magnitude (ΔCPM) and Change in Pain Intensity
The association between baseline Conditioned Pain Modulation (CPM) magnitude (ΔCPM) and the % pain reduction from baseline will be determined by bivariate regression.
Measured: 0-240 min from infusion
Change in Neuropathic Pain Symptom Inventory (NPSI) Score
Changes in the Neuropathic Pain Symptom Inventory (NPSI) total score will be compared between treatment sessions.
NPSI is a questionnaire used to assess and quantify neuropathic pain by asking patients to rate the severity of different pain sensations on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The version administered in the study consists of seven questions, each rated on a scale from 0 to 10, with the total score being the sum of all ratings.
The possible range of the NPSI score of the version administered in the study is 70, and, since we measure the difference in scores, the changes in the NPSI score of the version administered in the study is -70 to 70. Higher NPSI scores indicate more severe neuropathic pain symptoms. Since the analysis is conducted on changes in NPSI scores from baseline, a more negative value corresponds to a greater reduction in neuropathic pain symptoms following treatment.
Measured: baseline to 70 min after infusion

Timeline

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

31 Jan 20213 Nov 2023

First posted26 Oct 2020
Study start31 Jan 2021
Primary completion21 Oct 2023
Study completion3 Nov 2023

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 (3)Papers the sponsor has linked to this study.
Other trials for Neuropathic PainStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Prospective, randomized, double blind, crossover study
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04603066
Sponsor's protocol ID: 202008183
Status last verified: Jul 2025
First submitted: 21 Sep 2020
Last updated: 14 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.
PubMed 27115670
Yawn BP, Wollan PC, Weingarten TN, Watson JC, Hooten WM, Melton LJ 3rd. The prevalence of neuropathic pain: clinical evaluation compared with screening tools in a community population. Pain Med. 2009 Apr;10(3):586-93. doi: 10.1111/j.1526-4637.2009.00588.x. Epub 2009 Mar 17.
PubMed 20849570
Smith BH, Torrance N. Epidemiology of neuropathic pain and its impact on quality of life. Curr Pain Headache Rep. 2012 Jun;16(3):191-8. doi: 10.1007/s11916-012-0256-0.
PubMed 22395856

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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A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
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Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain

All Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Administration of Ondansetron With P-glycoprotein Inhibitor Tariquidar in Patients With Neuropathic Pain
ClinicalTrials.gov ID: NCT04603066
Acronym / sponsor ID: 202008183
Conditions: Neuropathic Pain
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 31 Jan 2021 (actual)
Primary completion: 21 Oct 2023 (actual)
Study completion: 3 Nov 2023 (actual)
First posted: 26 Oct 2020 (actual)
Results: Posted 14 Aug 2025

Clinical summary

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

Prospective, randomized, double-blind, placebo controlled, cross-over proof of concept study.

To determine the pharmacokinetics and tolerability of co-administration of 5-HT3R antagonist ondansetron with a P-glycoprotein inhibitor tariquidar, in patients with neuropathic pain.

Detailed description

Be tolerable in patients with neuropathic pain.
Increase the cerebrospinal fluid (CSF) to plasma ratio of ondansetron after intravenous administration, compare to ondansetron alone
Result in a greater reduction in pain intensity than with ondansetron alone.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Prospective, randomized, double blind, crossover study

Arm	Type	Receives
Ondansetron/Placebo first, then Ondansetron/Tariquidar	Other	Drug: Ondansetron 16 mg with Tariquidar, Drug: Ondansetron 16 mg with PlaceboThe study group where patients received Ondansetron with Placebo during Visit 1, and after a washout period of 3 weeks Ondansetron with Tariquidar at Visit 2 per the randomization schedule. Ondansetron 16 mg was administered IV over 60 minutes with placebo (D5W) or with tariquidar (4mg/kg dose in D5W). Ondansetron was diluted in 100mL 0.9% normal saline, and tariquidar was diluted in 500mL D5W.
Ondansetron/Tariquidar first, then Ondansetron/Placebo	Other	Drug: Ondansetron 16 mg with Tariquidar, Drug: Ondansetron 16 mg with PlaceboThe study group where patients received Ondansetron with Tariquidar during Visit 1, and after 3 weeks of washout period Ondansetron with Placebo at Visit 2 per the randomization schedule. Ondansetron 16 mg was administered IV over 60 minutes with tariquidar (4mg/kg dose in D5W) or with placebo (D5W). Ondansetron was diluted in 100mL 0.9% normal saline, and tariquidar was diluted in 500mL D5W.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 18-65;
Documented diagnosis of neuropathic pain due to damage or disease affecting the peripheral nervous system;
At least Probable neuropathic pain grading1;
Pain duration >3 months;
Average pain intensity ≥4 on 0-10 numerical rating scale (NRS).

Key exclusion criteria (12 listed)

Current pregnancy or lactation;
Moderate-severe kidney or liver dysfunction;
Active cardiac arrhythmias (non-sinus rhythm), Long QT syndrome, or QTc interval >450msec;
Congestive heart failure
Abnormal troponin values at screening visit;

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
Ondansetron 16 mg with TariquidarAlso: Ondansetron/TariquidarIn randomized order, each participant will receive two IV infusions of ondansetron, 3 weeks apart; one with placebo (D5W), and one with tariquidar (4mg/kg dose in D5W) administered IV over 60 minutes. Ondansetron will be diluted in 100mL 0.9% normal saline, and tariquidar will be diluted in 500mL D5W.	Drug	Ondansetron/Placebo first, then Ondansetron/Tariquidar, Ondansetron/Tariquidar first, then Ondansetron/Placebo
Ondansetron 16 mg with PlaceboAlso: Ondansetron/ PlaceboIn randomized order, each participant will receive two IV infusions of ondansetron, 3 weeks apart; one with placebo (D5W), and one with tariquidar (4mg/kg dose in D5W) administered IV over 60 minutes. Ondansetron will be diluted in 100mL 0.9% normal saline, and tariquidar will be diluted in 500mL D5W.	Drug	Ondansetron/Placebo first, then Ondansetron/Tariquidar, Ondansetron/Tariquidar first, then Ondansetron/Placebo

Primary outcome

Concertation-time Profile of Ondansetron in Plasma, Measured by the Area Under the Concentration-time Curve (AUC)
Time frame: Measurements over 240 minutes, extrapolated to infinity
AUCinf for Ondansetron concentration in plasma based on venous blood sampling for plasma concentrations of ondansetron obtained at 0, 15, 30, 60, 90, 120, 180, and 240 minutes from the beginning of ondansetron infusion.
Cerebrospinal Fluid to Plasma Concentration Ratio of Ondansetron
Time frame: anytime between 0-240 minutes
The level of ondansetron in plasma and CSF (cerebrospinal fluid) in samples, taken around the same time, was measured, and the ratio of the two values was calculated. This ratio (partition coefficient, Kp) of ondansetron, compared between the two sessions, with placebo vs tariquidar

4 secondary outcomes

% Change in Pain Intensity
Time frame: baseline to 90 minutes after ondansetron IV infusion
Conditioned Pain Modulation (CPM) Magnitude (ΔCPM)
Time frame: Baseline and 90 minutes after the end of ondansetron infusion
Correlation Between CPM Magnitude (ΔCPM) and Change in Pain Intensity
Time frame: 0-240 min from infusion
Change in Neuropathic Pain Symptom Inventory (NPSI) Score
Time frame: baseline to 70 min after infusion

Results and safety

Results posted to the registry on 14 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ondansetron/Placebo First, Then Ondasetron/Tariquidar	12	12
Ondansetron/Tariquidar First, Then Ondansetron/Placebo	12	12

Primary outcome: Concertation-time Profile of Ondansetron in Plasma, Measured by the Area Under the Concentration-time Curve (AUC)

Time frame: Measurements over 240 minutes, extrapolated to infinity. Mean (Standard Deviation). Unit: mg*hr/L

Measure	Ondansetron + Tariquidar n = 22	Ondansetron + Placebo n = 22
Value	0.89 (0.29)	0.87 (0.45)

Ondansetron + Tariquidar vs Ondansetron + Placebo: Mean Difference (Final Values): 0.0204257 (95% CI -0.2624635 to 0.2216122), p = 0.8651, t-test, 2 sided

Population analysed: participants who completed both sessions

Primary outcome: Cerebrospinal Fluid to Plasma Concentration Ratio of Ondansetron

Time frame: anytime between 0-240 minutes. Mean (Standard Error). Unit: ratio

Measure	Ondansetron + Tariquidar n = 7	Ondansetron + Placebo n = 7
Value	0.132 (0.017)	0.112 (0.018)

Ondansetron + Tariquidar vs Ondansetron + Placebo: Mean Difference (Net): 0.01727052 (95% CI -0.0005895 to 0.03513063), p = 0.056, t-test, 2 sided

Population analysed: Participant who had both CSF and plasma samples drawn at the same time, at both sessions.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ondansetron + Tariquidar	0 of 23 (0%)	12 of 23 (52.2%)	0 of 23
Ondansetron + Placebo	0 of 24 (0%)	19 of 24 (79.2%)	0 of 24

Limitations and caveats (from the sponsor): Due to ethical considerations, cerebrospinal fluid (CSF) sampling was optional in the study, therefore data on plasma/CSF ratio is not available for all patients. A total of 24 patients were enrolled out of 28 participant planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27115670Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.
Background: PubMed 20849570Yawn BP, Wollan PC, Weingarten TN, Watson JC, Hooten WM, Melton LJ 3rd. The prevalence of neuropathic pain: clinical evaluation compared with screening tools in a community population. Pain Med. 2009 Apr;10(3):586-93. doi: 10.1111/j.1526-4637.2009.00588.x. Epub 2009 Mar 17.
Background: PubMed 22395856Smith BH, Torrance N. Epidemiology of neuropathic pain and its impact on quality of life. Curr Pain Headache Rep. 2012 Jun;16(3):191-8. doi: 10.1007/s11916-012-0256-0.

Related trials for Neuropathic Pain

RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
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Not yet recruitingPhase 1
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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.

Simon Haroutounian, PhD principal investigator

Washington University School of Medicine

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ondansetron 16 mg with Tariquidar in people with Neuropathic Pain, run by Washington University School of Medicine 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 5 inclusion and 12 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 Aug 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 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.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Aug 2025). 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?

Concertation-time Profile of Ondansetron in Plasma, Measured by the Area Under the Concentration-time Curve (AUC) (time frame: Measurements over 240 minutes, extrapolated to infinity). 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 NCT04603066, which also lists 3 linked publications.

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 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.