Post-operative Dental PainPhase 3NCT03224403
Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain
A Phase 3 study testing Test acetaminophen, Commercial acetaminophen and Commercial ibuprofen in people with Post-operative Dental Pain, run by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division at 1 site in United States.
Trial summary
To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg… Read more about this study
- Who is it for?
- Ages 17 to 50 years
- Conditions the study is for
- Post-operative Dental Pain
- What is being tested?
- Test acetaminophen, Commercial acetaminophen and Commercial ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 664 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2017to 12 Apr 2018
- 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 17 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 17 to 50 years old
- Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)
- Dental extraction of three or four third molars
- Meets post-surgical pain criteria
- Females of childbearing age must be willing to use acceptable method of birth control
Who cannot join
- Currently pregnant or planning to be pregnant or nursing a baby
- Known allergy to acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin, as well as hydrocodone or other opioids
- Inability to swallow whole large tablets or capsules
- Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study
- Use of pain medications 5 or more times per week
- Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the last 5 years
- History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
- Have a positive urine drug screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy and Safety Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.
Read the detailed description
This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test ACM 1000 mg compared with two commercial products over a four-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.
- Conditions
- Post-operative Dental Pain
- Being tested
- Test acetaminophen, Commercial acetaminophen, Commercial ibuprofen, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test acetaminophenDrug
Also called Test ACM
single dose of 2 Test acetaminophen 500 mg tablets
Commercial acetaminophenDrug
Also called Commercial ACM
single dose of 2 acetaminophen 500 mg caplets
Commercial ibuprofenDrug
Also called Commercial IBU
Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules
PlaceboDrug
2 placebo caplets
| Study group | Role | What they receive |
|---|---|---|
| Test acetaminophen | Experimental | Test acetaminophen 1000 mg dose Receives: Drug: Test acetaminophen |
| Commercial acetaminophen | Active comparator | Commercial acetaminophen 1000 mg dose Receives: Drug: Commercial acetaminophen |
| Commercial ibuprofen | Active comparator | Commercial ibuprofen, 400 mg dose Receives: Drug: Commercial ibuprofen |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Confirmed Perceptible Pain Relief
Minutes until confirmed perceptible pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
Measured: within 4 hours
Secondary outcomes (21)
Time to Meaningful Pain Relief
Minutes until meaningful pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participants are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them.
Measured: Within 4 hours
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes
Percentage of participants with confirmed perceptible relief by 30 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 30 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes
Percentage of participants with confirmed perceptible relief by 29 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 29 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes
Percentage of participants with confirmed perceptible relief by 28 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 28 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes
Percentage of participants with confirmed perceptible relief by 27 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 27 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 26 Minutes
Percentage of participants with confirmed perceptible relief by 26 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 26 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 25 Minutes
Percentage of participants with confirmed perceptible relief by 25 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 25 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 24 Minutes
Percentage of participants with confirmed perceptible relief by 24 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 24 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 23 Minutes
Percentage of participants with confirmed perceptible relief by 23 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 23 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 22 Minutes
Percentage of participants with confirmed perceptible relief by 22 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 22 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 21 Minutes
Percentage of participants with confirmed perceptible relief by 21 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 21 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 20 Minutes
Percentage of participants with confirmed perceptible relief by 20 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 20 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 19 Minutes
Percentage of participants with confirmed perceptible relief by 19 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 19 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 18 Minutes
Percentage of participants with confirmed perceptible relief by 18 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 18 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 17 Minutes
Percentage of participants with confirmed perceptible relief by 17 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 17 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 16 Minutes
Percentage of participants with confirmed perceptible relief by 16 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 16 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 15 Minutes
Percentage of participants with confirmed perceptible relief by 15 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 15 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 14 Minutes
Percentage of participants with confirmed perceptible relief by 14 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 14 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 13 Minutes
Percentage of participants with confirmed perceptible relief by 13 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 13 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 12 Minutes
Percentage of participants with confirmed perceptible relief by 12 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 12 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 11 Minutes
Percentage of participants with confirmed perceptible relief by 11 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.
Measured: by 11 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start19 Jul 2017
- Primary completion4 Apr 2018
- Study completion12 Apr 2018
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 (2)Papers the sponsor has linked to this study.
- Other trials for Post-operative Dental 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
- Parallel groups
- Model description
- Post-operative dental pain following third molar extraction.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Consumer and Personal Products Worldwide
- Responsible party
- Sponsor
- Investigators
- Derek Muse, Principal investigator, Jean Brown Research/ BB Holdings
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224403
- Sponsor's protocol ID
- CO-170317095828-PACT
- Status last verified
- Apr 2019
- First submitted
- 7 Jul 2017
- Last updated
- 15 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: YODA
Publications
Myers A, Bertoch T, Zhang P, Cooper SA. Clinical validation of a fast-acting acetaminophen: a randomized, active and placebo controlled dental pain study. Curr Med Res Opin. 2024 May;40(5):839-848. doi: 10.1080/03007995.2024.2331159. Epub 2024 Mar 23.
PubMed 38505928Myers A, Gelotte C, Zuckerman A, Zimmerman B, Shenoy A, Qi D, Cooper SA. Analgesic onset and efficacy of a fast-acting formulation of acetaminophen in a postoperative dental impaction pain model. Curr Med Res Opin. 2024 Feb;40(2):267-277. doi: 10.1080/03007995.2023.2294946. Epub 2024 Jan 24.
PubMed 38124555
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy and Safety Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
- ClinicalTrials.gov ID
- NCT03224403
- Acronym / sponsor ID
- CO-170317095828-PACT
- Conditions
- Post-operative Dental Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Consumer and Personal Products Worldwide
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 15 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.
Detailed description
This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test ACM 1000 mg compared with two commercial products over a four-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Post-operative dental pain following third molar extraction.
| Arm | Type | Receives |
|---|---|---|
| Test acetaminophen | Experimental | Drug: Test acetaminophenTest acetaminophen 1000 mg dose |
| Commercial acetaminophen | Active comparator | Drug: Commercial acetaminophenCommercial acetaminophen 1000 mg dose |
| Commercial ibuprofen | Active comparator | Drug: Commercial ibuprofenCommercial ibuprofen, 400 mg dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 17 to 50 years old
- Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)
- Dental extraction of three or four third molars
- Meets post-surgical pain criteria
- Females of childbearing age must be willing to use acceptable method of birth control
Key exclusion criteria (8 listed)
- Currently pregnant or planning to be pregnant or nursing a baby
- Known allergy to acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin, as well as hydrocodone or other opioids
- Inability to swallow whole large tablets or capsules
- Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study
- Use of pain medications 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 |
|---|---|---|
| Test acetaminophenAlso: Test ACMsingle dose of 2 Test acetaminophen 500 mg tablets | Drug | Test acetaminophen |
| Commercial acetaminophenAlso: Commercial ACMsingle dose of 2 acetaminophen 500 mg caplets | Drug | Commercial acetaminophen |
| Commercial ibuprofenAlso: Commercial IBUSingle dose of 2 ibuprofen 200 mg Liquid-filled Capsules | Drug | Commercial ibuprofen |
| Placebo2 placebo caplets | Drug | Placebo |
Primary outcome
Time to Confirmed Perceptible Pain Relief
Time frame: within 4 hours
Minutes until confirmed perceptible pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
21 secondary outcomes
Time to Meaningful Pain Relief
Time frame: Within 4 hours
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes
Time frame: by 30 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes
Time frame: by 29 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes
Time frame: by 28 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes
Time frame: by 27 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 26 Minutes
Time frame: by 26 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 25 Minutes
Time frame: by 25 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 24 Minutes
Time frame: by 24 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 23 Minutes
Time frame: by 23 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 22 Minutes
Time frame: by 22 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 21 Minutes
Time frame: by 21 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 20 Minutes
Time frame: by 20 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 19 Minutes
Time frame: by 19 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 18 Minutes
Time frame: by 18 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 17 Minutes
Time frame: by 17 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 16 Minutes
Time frame: by 16 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 15 Minutes
Time frame: by 15 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 14 Minutes
Time frame: by 14 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 13 Minutes
Time frame: by 13 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 12 Minutes
Time frame: by 12 minutes
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 11 Minutes
Time frame: by 11 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38505928Myers A, Bertoch T, Zhang P, Cooper SA. Clinical validation of a fast-acting acetaminophen: a randomized, active and placebo controlled dental pain study. Curr Med Res Opin. 2024 May;40(5):839-848. doi: 10.1080/03007995.2024.2331159. Epub 2024 Mar 23.
- Derived from this study: PubMed 38124555Myers A, Gelotte C, Zuckerman A, Zimmerman B, Shenoy A, Qi D, Cooper SA. Analgesic onset and efficacy of a fast-acting formulation of acetaminophen in a postoperative dental impaction pain model. Curr Med Res Opin. 2024 Feb;40(2):267-277. doi: 10.1080/03007995.2023.2294946. Epub 2024 Jan 24.
- Individual participant dataSharing planned: Yes. YODA
Related trials for Post-operative Dental Pain
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
Enrolling by invitation
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
Pain, Postoperative, Root Resorption
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.
Derek Muse principal investigator
Jean Brown Research/ BB Holdings
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test acetaminophen, Commercial acetaminophen and Commercial ibuprofen in people with Post-operative Dental Pain, run by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 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 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 15 Apr 2021. 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 15 Apr 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?
Time to Confirmed Perceptible Pain Relief (time frame: within 4 hours). 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 NCT03224403, which also lists 2 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 15 Apr 2021.