PainPhase 3NCT05761574

A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

A Phase 3 study testing Acetaminophen/Naproxen Sodium Fixed Combination, Naproxen Sodium and Acetaminophen in people with Pain, run by Johnson & Johnson Consumer Inc. (J&JCI) 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

The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo. Read more about this study

Who is it for?: Ages 16 to 50 years
Conditions the study is for: Pain
What is being tested?: Acetaminophen/Naproxen Sodium Fixed Combination, Naproxen Sodium and Acetaminophen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 447 participants
Where: 1 siteUnited States
Study dates: 22 May 2023to 30 May 2024
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 16 to 50 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
Surgical removal of three or four third molars, of which, two must be mandibular impactions
Meets requirements for post-surgical pain level
Females of childbearing potential and males agree to contraceptive requirements of study
Have a negative urine drug screen at screening, and on day of surgical procedure

Who cannot join

Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
Have a known allergy or hypersensitivity to naproxen (or other NSAIDs including aspirin) or to acetaminophen, oxycodone or other opioids
Not able to swallow whole large tablets or capsules
History of any condition(s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
Use analgesics 5 or more times per week
History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years
Use any immunosuppressive drugs within 2 weeks of surgical procedure
History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

Trial locations and contacts

1 site in 1 country.

United States1 site

JBR Clinical Research LLC
Salt Lake City, Utah, 84107

Other trials in United States

About this study

Official title: A Full-Factorial, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Efficacy and Safety Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen, and Naproxen Sodium in Postoperative Dental Pain

The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, single-dose full-factorial study to evaluate the analgesic efficacy and safety of a fixed combination of acetaminophen and naproxen sodium, compared with acetaminophen or naproxen sodium alone, and placebo following surgical extraction of three or four third molars.

Conditions: Pain
Being tested: Acetaminophen/Naproxen Sodium Fixed Combination, Naproxen Sodium, Acetaminophen, Placebo
Keywords: Analgesics, Dental Pain, Acetaminophen, Naproxen Sodium, Pain, Fixed-Dose
Medical subject headings: Pain, Toothache

What participants receive

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

Acetaminophen/Naproxen Sodium Fixed CombinationDrug
Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
Naproxen SodiumDrug
Naproxen Sodium will be administered orally.
AcetaminophenDrug
Acetaminophen will be administered orally.
PlaceboDrug
Placebo will be administered orally.

Study groups in NCT05761574
Study group	Role	What they receive
Acetaminophen/Naproxen Sodium Fixed Combination	Experimental	Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets. Receives: Drug: Acetaminophen/Naproxen Sodium Fixed Combination
Naproxen Sodium	Active comparator	Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule. Receives: Drug: Naproxen Sodium; Drug: Placebo
Acetaminophen	Active comparator	Participants will receive a single oral dose of two Acetaminophen tablets. Receives: Drug: Acetaminophen
Placebo	Placebo comparator	Participants will receive a single oral dose of two Placebo capsules. Receives: Drug: Placebo

What is being measured

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

Time-weighted Sum of Pain Intensity Difference From 0 to 12 Hours After Dosing (SPID 0-12)
Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity.
The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 0-12 hours. PID is ranging from 0 to 10 point and SPID 0-12 ranging from 0 to 120. A higher value of SPID indicated greater pain relief.
Measured: Baseline (0 hour) up to 12 hours post-dose

Secondary outcomes (3)

Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12)
Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity.
The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 6-12 hours. PID is ranging from 0 to 10 point and SPID6-12 ranging from 0 to 60. A higher value of SPID indicated greater pain relief.
Measured: From 6 to 12 hours
Time to First Request of Rescue Analgesic
Time to first request for rescue medication was measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested.
Measured: 0 to 24 hours
Proportion of Subjects Who Request Rescue Analgesic During the First 12 Hours
Proportion of participants who requested rescue analgesic during the first 12 hours was reported.
Measured: Up to 12 hours

Timeline

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

22 May 202330 May 2024

First posted9 Mar 2023
Study start22 May 2023
Primary completion17 May 2024
Study completion30 May 2024

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 (21)Papers the sponsor has linked to this study.
Other trials for PainStudies 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: Factorial
Model description: Post-operative dental pain following third molar extraction.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 447 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05761574
Sponsor's protocol ID: CCSPAA005199
Other IDs: CCSPAA005199
Status last verified: Aug 2026
First submitted: 27 Feb 2023
Last updated: 3 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Publications

World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
PubMed 24141714
GUZMAN F, BRAUN C, LIM RK, POTTER GD, RODGERS DW. NARCOTIC AND NON-NARCOTIC ANALGESICS WHICH BLOCK VISCERAL PAIN EVOKED BY INTRA-ARTERIAL INJECTION OF BRADYKININ AND OTHER ALGESIC AGENTS. Arch Int Pharmacodyn Ther. 1964 Jun 1;149:571-88. No abstract available.
PubMed 14191090
LIM RK, GUZMAN F, RODGERS DW, GOTO K, BRAUN C, DICKERSON GD, ENGLE RJ. SITE OF ACTION OF NARCOTIC AND NON-NARCOTIC ANALGESICS DETERMINED BY BLOCKING BRADYKININ-EVOKED VISCERAL PAIN. Arch Int Pharmacodyn Ther. 1964 Nov 1;152:25-58. No abstract available.
PubMed 14248351
Aronoff DM, Oates JA, Boutaud O. New insights into the mechanism of action of acetaminophen: Its clinical pharmacologic characteristics reflect its inhibition of the two prostaglandin H2 synthases. Clin Pharmacol Ther. 2006 Jan;79(1):9-19. doi: 10.1016/j.clpt.2005.09.009. No abstract available.
PubMed 16413237
Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.
PubMed 16580905
Mallet C, Daulhac L, Bonnefont J, Ledent C, Etienne M, Chapuy E, Libert F, Eschalier A. Endocannabinoid and serotonergic systems are needed for acetaminophen-induced analgesia. Pain. 2008 Sep 30;139(1):190-200. doi: 10.1016/j.pain.2008.03.030. Epub 2008 May 15.
PubMed 18485596
Koch-Weser J. Drug therapy. Acetaminophen. N Engl J Med. 1976 Dec 2;295(23):1297-300. doi: 10.1056/NEJM197612022952306. No abstract available.
PubMed 790189
Milton AS. Modern views on the pathogenesis of fever and the mode of action of antipyretic drugs. J Pharm Pharmacol. 1976 Apr;28(4 SUPPL):393-9. doi: 10.1111/j.2042-7158.1976.tb04186.x. No abstract available.
PubMed 6743
Ameer B, Greenblatt DJ. Acetaminophen. Ann Intern Med. 1977 Aug;87(2):202-9. doi: 10.7326/0003-4819-87-2-202.
PubMed 329728
Product Monograph for Aleve (Naproxen Sodium Tablets USP/Liquid Gels/Capsules 220 mg). Bayer Inc. Consumer Care. Revised 8 January 2015
Todd PA, Clissold SP. Naproxen. A reappraisal of its pharmacology, and therapeutic use in rheumatic diseases and pain states. Drugs. 1990 Jul;40(1):91-137. doi: 10.2165/00003495-199040010-00006.
PubMed 2202585
Davies NM, Anderson KE. Clinical pharmacokinetics of naproxen. Clin Pharmacokinet. 1997 Apr;32(4):268-93. doi: 10.2165/00003088-199732040-00002.
PubMed 9113437
Cooper SA, Desjardins PJ. The value of the dental impaction pain model in drug development. Methods Mol Biol. 2010;617:175-90. doi: 10.1007/978-1-60327-323-7_15.
PubMed 20336423
Cooper SA, Desjardins PJ, Turk DC, Dworkin RH, Katz NP, Kehlet H, Ballantyne JC, Burke LB, Carragee E, Cowan P, Croll S, Dionne RA, Farrar JT, Gilron I, Gordon DB, Iyengar S, Jay GW, Kalso EA, Kerns RD, McDermott MP, Raja SN, Rappaport BA, Rauschkolb C, Royal MA, Segerdahl M, Stauffer JW, Todd KH, Vanhove GF, Wallace MS, West C, White RE, Wu C. Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations. Pain. 2016 Feb;157(2):288-301. doi: 10.1097/j.pain.0000000000000375.
PubMed 26683233
Lipkovich I, Ratitch B, O'Kelly M. Sensitivity to censored-at-random assumption in the analysis of time-to-event endpoints. Pharm Stat. 2016 May;15(3):216-29. doi: 10.1002/pst.1738. Epub 2016 Mar 21.
PubMed 26997353

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?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Full-Factorial, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Efficacy and Safety Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen, and Naproxen Sodium in Postoperative Dental Pain
ClinicalTrials.gov ID: NCT05761574
Acronym / sponsor ID: CCSPAA005199
Conditions: Pain
Keywords: Analgesics, Dental Pain, Acetaminophen, Naproxen Sodium, Pain, Fixed-Dose
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 447 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 22 May 2023 (actual)
Primary completion: 17 May 2024 (actual)
Study completion: 30 May 2024 (actual)
First posted: 9 Mar 2023 (actual)
Results: Posted 3 Nov 2026

Clinical summary

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

The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: Post-operative dental pain following third molar extraction.

Arm	Type	Receives
Acetaminophen/Naproxen Sodium Fixed Combination	Experimental	Drug: Acetaminophen/Naproxen Sodium Fixed CombinationParticipants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets.
Naproxen Sodium	Active comparator	Drug: Naproxen Sodium, Drug: PlaceboParticipants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.
Acetaminophen	Active comparator	Drug: AcetaminophenParticipants will receive a single oral dose of two Acetaminophen tablets.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive a single oral dose of two Placebo capsules.

Who may qualify

Ages: 16 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
Surgical removal of three or four third molars, of which, two must be mandibular impactions
Meets requirements for post-surgical pain level
Females of childbearing potential and males agree to contraceptive requirements of study
Have a negative urine drug screen at screening, and on day of surgical procedure

Key exclusion criteria (8 listed)

Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
Have a known allergy or hypersensitivity to naproxen (or other NSAIDs including aspirin) or to acetaminophen, oxycodone or other opioids
Not able to swallow whole large tablets or capsules
History of any condition(s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
Use analgesics 5 or more times per week

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
Acetaminophen/Naproxen Sodium Fixed CombinationFixed combination of Acetaminophen/Naproxen Sodium will be administered orally.	Drug	Acetaminophen/Naproxen Sodium Fixed Combination
Naproxen SodiumNaproxen Sodium will be administered orally.	Drug	Naproxen Sodium
AcetaminophenAcetaminophen will be administered orally.	Drug	Acetaminophen
PlaceboPlacebo will be administered orally.	Drug	Naproxen Sodium, Placebo

Primary outcome

Time-weighted Sum of Pain Intensity Difference From 0 to 12 Hours After Dosing (SPID 0-12)
Time frame: Baseline (0 hour) up to 12 hours post-dose
Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity. The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 0-12 hours. PID is ranging from 0 to 10 point and SPID 0-12 ranging from 0 to 120. A higher value of SPID indicated greater pain relief.

3 secondary outcomes

Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12)
Time frame: From 6 to 12 hours
Time to First Request of Rescue Analgesic
Time frame: 0 to 24 hours
Proportion of Subjects Who Request Rescue Analgesic During the First 12 Hours
Time frame: Up to 12 hours

Results and safety

Results posted to the registry on 3 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acetaminophen/Naproxen Sodium Fixed Combination	160	159
Naproxen Sodium	162	161
Acetaminophen	82	81
Placebo	43	43

Primary outcome: Time-weighted Sum of Pain Intensity Difference From 0 to 12 Hours After Dosing (SPID 0-12)

Time frame: Baseline (0 hour) up to 12 hours post-dose. Least squares mean (Standard Error). Unit: units on a scale*hours

Measure	Acetaminophen/Naproxen Sodium Fixed Combination n = 160	Naproxen Sodium n = 162	Acetaminophen n = 82	Placebo n = 43
Value	49.33 (2.090)	40.74 (2.075)	24.01 (2.912)	4.11 (4.002)

Population analysed: Intention to Treat Analysis Set including all randomized subjects

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected starting from the time a subject signed and dated the informed consent and until the completion of the subject's last study-related procedure, including contact for follow-up of safety, up to Day 10.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acetaminophen/Naproxen Sodium Fixed Combination	0 of 160 (0%)	8 of 160 (5%)	0 of 160
Naproxen Sodium	0 of 162 (0%)	8 of 162 (4.9%)	0 of 162
Acetaminophen	0 of 82 (0%)	5 of 82 (6.1%)	0 of 82
Placebo	0 of 43 (0%)	7 of 43 (16.3%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24141714World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
Background: PubMed 14191090GUZMAN F, BRAUN C, LIM RK, POTTER GD, RODGERS DW. NARCOTIC AND NON-NARCOTIC ANALGESICS WHICH BLOCK VISCERAL PAIN EVOKED BY INTRA-ARTERIAL INJECTION OF BRADYKININ AND OTHER ALGESIC AGENTS. Arch Int Pharmacodyn Ther. 1964 Jun 1;149:571-88. No abstract available.
Background: PubMed 14248351LIM RK, GUZMAN F, RODGERS DW, GOTO K, BRAUN C, DICKERSON GD, ENGLE RJ. SITE OF ACTION OF NARCOTIC AND NON-NARCOTIC ANALGESICS DETERMINED BY BLOCKING BRADYKININ-EVOKED VISCERAL PAIN. Arch Int Pharmacodyn Ther. 1964 Nov 1;152:25-58. No abstract available.
Background: PubMed 16413237Aronoff DM, Oates JA, Boutaud O. New insights into the mechanism of action of acetaminophen: Its clinical pharmacologic characteristics reflect its inhibition of the two prostaglandin H2 synthases. Clin Pharmacol Ther. 2006 Jan;79(1):9-19. doi: 10.1016/j.clpt.2005.09.009. No abstract available.
Background: PubMed 16580905Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.
Background: PubMed 18485596Mallet C, Daulhac L, Bonnefont J, Ledent C, Etienne M, Chapuy E, Libert F, Eschalier A. Endocannabinoid and serotonergic systems are needed for acetaminophen-induced analgesia. Pain. 2008 Sep 30;139(1):190-200. doi: 10.1016/j.pain.2008.03.030. Epub 2008 May 15.
Background: PubMed 790189Koch-Weser J. Drug therapy. Acetaminophen. N Engl J Med. 1976 Dec 2;295(23):1297-300. doi: 10.1056/NEJM197612022952306. No abstract available.
Background: PubMed 6743Milton AS. Modern views on the pathogenesis of fever and the mode of action of antipyretic drugs. J Pharm Pharmacol. 1976 Apr;28(4 SUPPL):393-9. doi: 10.1111/j.2042-7158.1976.tb04186.x. No abstract available.
Background: PubMed 329728Ameer B, Greenblatt DJ. Acetaminophen. Ann Intern Med. 1977 Aug;87(2):202-9. doi: 10.7326/0003-4819-87-2-202.
BackgroundProduct Monograph for Aleve (Naproxen Sodium Tablets USP/Liquid Gels/Capsules 220 mg). Bayer Inc. Consumer Care. Revised 8 January 2015
Background: PubMed 2202585Todd PA, Clissold SP. Naproxen. A reappraisal of its pharmacology, and therapeutic use in rheumatic diseases and pain states. Drugs. 1990 Jul;40(1):91-137. doi: 10.2165/00003495-199040010-00006.
Background: PubMed 9113437Davies NM, Anderson KE. Clinical pharmacokinetics of naproxen. Clin Pharmacokinet. 1997 Apr;32(4):268-93. doi: 10.2165/00003088-199732040-00002.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

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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.

Marsha Tharakan, MD, DDS study director

Kenvue Brands LLC

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

Questions about this trial

What is this clinical trial studying?

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 8 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 3 Nov 2026. 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 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 3 Nov 2026). 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?

Time-weighted Sum of Pain Intensity Difference From 0 to 12 Hours After Dosing (SPID 0-12) (time frame: Baseline (0 hour) up to 12 hours post-dose). 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 NCT05761574, which also lists 21 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 3 Nov 2026.