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

Primary Purpose

Post Operative Dental Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
acetaminophen Tablet
acetaminophen Caplet
ibuprofen Liquid-filled capsule
Placebo Tablet
Placebo Caplet
Placebo Liquid-filled capsule
Sponsored by
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Dental Pain

Eligibility Criteria

17 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Test acetaminophen

Commercial acetaminophen

Commercial ibuprofen

Placebo

Arm Description

acetaminophen tablet and placebo caplet and placebo liquid-filled capsule

acetaminophen caplet and placebo tablet and placebo liquid-filled capsule

ibuprofen liquid-filled capsule and placebo tablet and placebo caplet

Placebo tablet and placebo caplet and placebo liquid-filled capsule

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)
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
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
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
Percentage of subjects with meaningful relief by 30 minutes
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.

Full Information

First Posted
March 31, 2016
Last Updated
September 21, 2022
Sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
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1. Study Identification

Unique Protocol Identification Number
NCT02735122
Brief Title
Study of Acetaminophen (ACM) in Post-operative Dental Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2016 (Actual)
Primary Completion Date
October 5, 2016 (Actual)
Study Completion Date
October 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Dental Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test acetaminophen
Arm Type
Experimental
Arm Description
acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
Arm Title
Commercial acetaminophen
Arm Type
Active Comparator
Arm Description
acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
Arm Title
Commercial ibuprofen
Arm Type
Active Comparator
Arm Description
ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet and placebo caplet and placebo liquid-filled capsule
Intervention Type
Drug
Intervention Name(s)
acetaminophen Tablet
Other Intervention Name(s)
Test ACM
Intervention Description
2 test acetaminophen 500 mg tablets
Intervention Type
Drug
Intervention Name(s)
acetaminophen Caplet
Other Intervention Name(s)
Commercial ACM
Intervention Description
2 commercial acetaminophen 500 mg caplets
Intervention Type
Drug
Intervention Name(s)
ibuprofen Liquid-filled capsule
Other Intervention Name(s)
Commercial IBU
Intervention Description
2 commercial ibuprofen 200 mg Liquid-filled capsules
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet
Intervention Description
2 placebo tablets
Intervention Type
Drug
Intervention Name(s)
Placebo Caplet
Intervention Description
2 placebo caplets
Intervention Type
Drug
Intervention Name(s)
Placebo Liquid-filled capsule
Intervention Description
2 placebo Liquid-filled capsules
Primary Outcome Measure Information:
Title
Time to first confirmed perceptible pain relief
Description
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
Secondary Outcome Measure Information:
Title
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
Title
Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)
Description
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
Title
Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)
Description
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
Title
Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)
Description
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
Title
Percentage of subjects with meaningful relief by 30 minutes
Time Frame
30 minutes or less
Title
Time to meaningful pain relief
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 17 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek D. Muse, M.D.
Organizational Affiliation
Jean Brown Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
At this time we do plan to share IPD through the YODA site. The specific individual participant data sets have not yet been determined.

Learn more about this trial

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

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