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

Post Operative Dental Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735122
• Other study ID #: CO-151027203834-PACT
• Status: Completed
• Phase: Phase 3
• Start date: April 30, 2016
• Est. completion date: October 5, 2016

Study information

• Verified date: September 2022
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: October 5, 2016
• Est. primary completion date: October 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Operative Dental Pain
• Toothache

Intervention

Drug:
• acetaminophen Tablet
2 test acetaminophen 500 mg tablets
• acetaminophen Caplet
2 commercial acetaminophen 500 mg caplets
• ibuprofen Liquid-filled capsule
2 commercial ibuprofen 200 mg Liquid-filled capsules
• Placebo Tablet
2 placebo tablets
• Placebo Caplet
2 placebo caplets
• Placebo Liquid-filled capsule
2 placebo Liquid-filled capsules

Locations

Country	Name	City	State
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	Johnson & Johnson Consumer and Personal Products Worldwide

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 hours
Secondary	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
Secondary	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	10 minutes or less
Secondary	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	15 minutes or less
Secondary	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	20 minutes or less
Secondary	Percentage of subjects with meaningful relief by 30 minutes		30 minutes or less
Secondary	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.	6 hours