Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

NCT03224403 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CO-170317095828-PACT
• Study Type: interventional
• Target: 664
• Locations: 1 country
• Sites: 1

Brief 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 liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.

Conditions

Post-operative Dental Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  within 4 hours

Secondary Outcomes (21)

• Time to Meaningful Pain Relief

  Within 4 hours

• Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes

  by 30 minutes

• Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes

  by 29 minutes

• Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes

  by 28 minutes

• Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes

  by 27 minutes

Study Arms (4)

Test acetaminophen

EXPERIMENTAL

Test acetaminophen 1000 mg dose

Drug: Test acetaminophen

Commercial acetaminophen

ACTIVE COMPARATOR

Commercial acetaminophen 1000 mg dose

Drug: Commercial acetaminophen

Commercial ibuprofen

ACTIVE COMPARATOR

Commercial ibuprofen, 400 mg dose

Drug: Commercial ibuprofen

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Test acetaminophen DRUG

single dose of 2 Test acetaminophen 500 mg tablets

Also known as: Test ACM

Test acetaminophen

Commercial acetaminophen DRUG

single dose of 2 acetaminophen 500 mg caplets

Also known as: Commercial ACM

Commercial acetaminophen

Commercial ibuprofen DRUG

Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules

Also known as: Commercial IBU

Commercial ibuprofen

Placebo DRUG

2 placebo caplets

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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 (2)

• 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.

  PMID: 38505928 DERIVED

• 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

Results Point of Contact

• Title: Andrew Myers, MD
• Organization: JNJWorldwide

AMyers3@its.jnj.com

(215) 273-8421 USA EST

Study Officials

• Derek Muse

  Jean Brown Research/ BB Holdings

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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

Model Details: Post-operative dental pain following third molar extraction.

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 21, 2017
• Study Start: July 19, 2017
• Primary Completion: April 4, 2018
• Study Completion: April 12, 2018
• Last Updated: April 15, 2021
• Results First Posted: April 15, 2021

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)