Study of Acetaminophen (ACM) in Post-operative Dental Pain

Phase 3

Completed

• Conditions: Post Operative Dental Pain
• Interventions: Drug: acetaminophen Caplet; Drug: ibuprofen Liquid-filled capsule; Drug: acetaminophen Tablet; Drug: Placebo Tablet; Drug: Placebo Caplet; Drug: Placebo Liquid-filled capsule

• Registration Number: NCT02735122
• Lead Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Study Start: 2016-04-30
• Primary Completion: 2016-10-05
• Study Completion: 2016-10-05
• Disposition First Submitted: 2017-10-09
• Disposition First Submitted QC: 2017-12-15
• Disposition First Posted: 2017-12-18
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

1. 17 years to 50 years old
2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
3. Dental extraction of three or four molars
4. Experience moderate to severe pain after extraction of third molars
5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion Criteria

1. Currently pregnant or planning to be pregnant or nursing a baby
2. Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS)
3. Inability to swallow whole large tablets or capsules
4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Commercial acetaminophen	acetaminophen Caplet	acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
Commercial ibuprofen	ibuprofen Liquid-filled capsule	ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
Commercial acetaminophen	Placebo Tablet	acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
Commercial ibuprofen	Placebo Caplet	ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
Test acetaminophen	acetaminophen Tablet	acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
Test acetaminophen	Placebo Liquid-filled capsule	acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
Test acetaminophen	Placebo Caplet	acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
Commercial acetaminophen	Placebo Liquid-filled capsule	acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
Commercial ibuprofen	Placebo Tablet	ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
Placebo	Placebo Tablet	Placebo tablet and placebo caplet and placebo liquid-filled capsule
Placebo	Placebo Caplet	Placebo tablet and placebo caplet and placebo liquid-filled capsule
Placebo	Placebo Liquid-filled capsule	Placebo tablet and placebo caplet and placebo liquid-filled capsule

Primary Outcome Measures

Name	Time	Method
Time to first confirmed perceptible pain relief	6 hours	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)	30 minutes or less
Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)	10 minutes or less	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
Percentage of subjects with meaningful relief by 30 minutes	30 minutes or less
Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)	15 minutes or less	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
Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)	20 minutes or less	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 to meaningful pain relief	6 hours	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.

Trial Locations

Locations (1)

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States