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

NCT02735122 | Completed Phase 3 FDA Drug

• 1 other identifier: CO-151027203834-PACT
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Dental Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)

  15 minutes or less

• Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)

  20 minutes or less

• Percentage of subjects with meaningful relief by 30 minutes

  30 minutes or less

Study Arms (4)

Test acetaminophen

EXPERIMENTAL

acetaminophen tablet and placebo caplet and placebo liquid-filled capsule

Drug: acetaminophen Tablet; Drug: Placebo Caplet; Drug: Placebo Liquid-filled capsule

Commercial acetaminophen

ACTIVE COMPARATOR

acetaminophen caplet and placebo tablet and placebo liquid-filled capsule

Drug: acetaminophen Caplet; Drug: Placebo Tablet; Drug: Placebo Liquid-filled capsule

Commercial ibuprofen

ACTIVE COMPARATOR

ibuprofen liquid-filled capsule and placebo tablet and placebo caplet

Drug: ibuprofen Liquid-filled capsule; Drug: Placebo Tablet; Drug: Placebo Caplet

Placebo

PLACEBO COMPARATOR

Placebo tablet and placebo caplet and placebo liquid-filled capsule

Drug: Placebo Tablet; Drug: Placebo Caplet; Drug: Placebo Liquid-filled capsule

Interventions

acetaminophen Tablet DRUG

2 test acetaminophen 500 mg tablets

Also known as: Test ACM

Test acetaminophen

acetaminophen Caplet DRUG

2 commercial acetaminophen 500 mg caplets

Also known as: Commercial ACM

Commercial acetaminophen

ibuprofen Liquid-filled capsule DRUG

2 commercial ibuprofen 200 mg Liquid-filled capsules

Also known as: Commercial IBU

Commercial ibuprofen

Placebo Tablet DRUG

2 placebo tablets

Commercial acetaminophen; Commercial ibuprofen; Placebo

Placebo Caplet DRUG

2 placebo caplets

Commercial ibuprofen; Placebo; Test acetaminophen

Placebo Liquid-filled capsule DRUG

2 placebo Liquid-filled capsules

Commercial acetaminophen; Placebo; Test acetaminophen

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Currently pregnant or planning to be pregnant or nursing a baby
• Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS)
• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division: lead
• Johnson & Johnson Consumer and Personal Products Worldwide: collaborator

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• Myers 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.

  PMID: 38124555 DERIVED

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Derek D. Muse, M.D.

  Jean Brown Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 12, 2016
• Study Start: April 30, 2016
• Primary Completion: October 5, 2016
• Study Completion: October 5, 2016
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)