A Phase 3 interventional study of acetaminophen Tablet and acetaminophen Caplet in Post Operative Dental Pain, sponsored by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Completed at 1 site in United States. Open to participants aged 17 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division · Phase 3, Interventional, and Treatment
This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.
This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.
140 studies on the registry are indexed under Toothache; 24 are open to participants now.
This study's enrollment of 420 is above the median of 100 across 121 interventional studies indexed under Toothache.
Browse Toothache studies →Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
Drug: acetaminophen Tablet · Drug: Placebo Caplet · Drug: Placebo Liquid-filled capsule
acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
Drug: acetaminophen Caplet · Drug: Placebo Tablet · Drug: Placebo Liquid-filled capsule
ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
Drug: ibuprofen Liquid-filled capsule · Drug: Placebo Tablet · Drug: Placebo Caplet
Placebo tablet and placebo caplet and placebo liquid-filled capsule
Drug: Placebo Tablet · Drug: Placebo Caplet · Drug: Placebo Liquid-filled capsule
2 test acetaminophen 500 mg tablets
Also known as: Test ACM
2 commercial acetaminophen 500 mg caplets
Also known as: Commercial ACM
2 commercial ibuprofen 200 mg Liquid-filled capsules
Also known as: Commercial IBU
2 placebo tablets
2 placebo caplets
2 placebo Liquid-filled capsules
Time to first confirmed perceptible pain relief
Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
Time frame: 6 hours
Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)
Time frame: 30 minutes or less
Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)
The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 10 minutes
Time frame: 10 minutes or less
Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)
The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 15 minutes
Time frame: 15 minutes or less
Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)
The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 20 minutes
Time frame: 20 minutes or less
Percentage of subjects with meaningful relief by 30 minutes
Time frame: 30 minutes or less
Time to meaningful pain relief
Minutes until meaningful pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subjects are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them.
Time frame: 6 hours
Plan to share: Yes — At this time we do plan to share IPD through the YODA site. The specific individual participant data sets have not yet been determined.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division