Back to resultsStudy of Acetaminophen (ACE) in Post-operative Dental Pain
Primary Purpose
Dental Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen (ACE) (1000 mg)
Commercial ACE (1000 mg)
Commercial Ibuprofen (IBU) (400 mg)
Placebo
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pain focused on measuring Molar,third; Teeth,wisdom; Pain, Postoperative; Dental Surgery; Third molar extraction
Eligibility Criteria
Inclusion Criteria:
- Are 17 to 50 years of age
- Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
- Dental extraction of three or four third-molars.
- Experience moderate to severe pain after extraction of third molars
Exclusion Criteria:
- Currently pregnant (or planning to be pregnant) or nursing a baby
- Known allergy to acetaminophen (ACE) 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
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 (ACE) (1000 mg) and placebo
Commerical ACE (1000 mg) and placebo
Commerical Ibuprofen (IBU) (400 mg) and placebo
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Time weighted sum of pain intensity difference from 0-6 hours (SPID 0-6)
Time weighted sum of pain intensity difference scores from baseline over 6 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Secondary Outcome Measures
Time weighted sum of pain intensity difference from 0-4 hours (SPID 0-4)
Time weighted sum of pain intensity difference scores from baseline over 4 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
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.
Time to first perceptible pain relief
Minutes until first perceptible pain relief is 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.
Time to confirmed first perceptible 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.
Time weighted sum of pain relief from 0-4 (TOTPAR 0-4)
Time weighted sum of pain relief scores over four hours. Pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time weighted sum of pain relief from 0-6 (TOTPAR 0-6)
Time weighted sum of pain relief scores over six hours. Pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Duration of relief after dosing (time to rescue analgesic)
Minutes until rescue medication is given
Proportion of subjects taking a rescue analgesic by 6 hours
Percentage of subjects using rescue medication through six hours
Subject Global Evaluation assessed at hour 6 or at time of rescue
Patient assessment of the pain medication - number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent
Pain relief (PAR) scores at 0.25 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain relief (PAR) scores at 0.5 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain relief (PAR) scores at 0.75 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain relief (PAR) scores at 1 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain relief (PAR) scores at 1.25 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain relief (PAR) scores at 1.5 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain relief (PAR) scores at 2 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain relief (PAR) scores at 3 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain relief (PAR) scores at 4 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain relief (PAR) scores at 5 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain relief (PAR) scores at 6 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Pain intensity difference (PID) at 0.25 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Pain intensity difference (PID) at 0.5 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Pain intensity difference (PID) at 0.75 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Pain intensity difference (PID) at 1 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Pain intensity difference (PID) at 1.25 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Pain intensity difference (PID) at 1.5 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Pain intensity difference (PID) at 2 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Pain intensity difference (PID) at 3 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Pain intensity difference (PID) at 4 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Pain intensity difference (PID) at 5 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Pain intensity difference (PID) at 6 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Full Information
NCT ID
NCT02320708
First Posted
December 16, 2014
Last Updated
November 29, 2021
Sponsor
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
1. Study Identification
Unique Protocol Identification Number
NCT02320708
Brief Title
Study of Acetaminophen (ACE) in Post-operative Dental Pain
Official Title
A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Proof of Concept Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 31, 2014 (Actual)
Primary Completion Date
April 30, 2015 (Actual)
Study Completion Date
April 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a dental pain study evaluating the efficacy and safety of a single dose of test acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU) (400 mg), and placebo over a 6 hour period. 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
Dental Pain
Keywords
Molar,third; Teeth,wisdom; Pain, Postoperative; Dental Surgery; Third molar extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Acetaminophen (ACE) (1000 mg) and placebo
Arm Type
Experimental
Arm Title
Commerical ACE (1000 mg) and placebo
Arm Type
Active Comparator
Arm Title
Commerical Ibuprofen (IBU) (400 mg) and placebo
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetaminophen (ACE) (1000 mg)
Intervention Description
2 Test ACE 500 mg tablets taken orally one time
Intervention Type
Drug
Intervention Name(s)
Commercial ACE (1000 mg)
Intervention Description
2 ACE 500 mg caplets taken orally one time
Intervention Type
Drug
Intervention Name(s)
Commercial Ibuprofen (IBU) (400 mg)
Intervention Description
2 IBU 200 mg soft-gels taken orally one time
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 placebo caplets for acetaminophen taken orally one time
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 placebo soft-gels for ibuprofen taken orally one time
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 placebo tablets for Test acetaminophen taken orally one time
Primary Outcome Measure Information:
Title
Time weighted sum of pain intensity difference from 0-6 hours (SPID 0-6)
Description
Time weighted sum of pain intensity difference scores from baseline over 6 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
6 Hours
Secondary Outcome Measure Information:
Title
Time weighted sum of pain intensity difference from 0-4 hours (SPID 0-4)
Description
Time weighted sum of pain intensity difference scores from baseline over 4 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
4 Hours
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
Within 6 Hours
Title
Time to first perceptible pain relief
Description
Minutes until first perceptible pain relief is 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.
Time Frame
Within 6 Hours
Title
Time to confirmed first perceptible 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
Within 6 Hours
Title
Time weighted sum of pain relief from 0-4 (TOTPAR 0-4)
Description
Time weighted sum of pain relief scores over four hours. Pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
4 hours
Title
Time weighted sum of pain relief from 0-6 (TOTPAR 0-6)
Description
Time weighted sum of pain relief scores over six hours. Pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
6 hours
Title
Duration of relief after dosing (time to rescue analgesic)
Description
Minutes until rescue medication is given
Time Frame
6 Hours
Title
Proportion of subjects taking a rescue analgesic by 6 hours
Description
Percentage of subjects using rescue medication through six hours
Time Frame
6 Hours
Title
Subject Global Evaluation assessed at hour 6 or at time of rescue
Description
Patient assessment of the pain medication - number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent
Time Frame
6 hours
Title
Pain relief (PAR) scores at 0.25 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
0.25 Hours
Title
Pain relief (PAR) scores at 0.5 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
0.5 Hours
Title
Pain relief (PAR) scores at 0.75 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
0.75 Hours
Title
Pain relief (PAR) scores at 1 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
1 Hours
Title
Pain relief (PAR) scores at 1.25 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
1.25 Hours
Title
Pain relief (PAR) scores at 1.5 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
1.5 Hours
Title
Pain relief (PAR) scores at 2 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
2 hoursH
Title
Pain relief (PAR) scores at 3 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
3 Hours
Title
Pain relief (PAR) scores at 4 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
4 Hours
Title
Pain relief (PAR) scores at 5 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
5 Hours
Title
Pain relief (PAR) scores at 6 Hours
Description
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Time Frame
6 Hours
Title
Pain intensity difference (PID) at 0.25 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
0.25 Hours
Title
Pain intensity difference (PID) at 0.5 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
0.5 Hours
Title
Pain intensity difference (PID) at 0.75 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
0.75 Hours
Title
Pain intensity difference (PID) at 1 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
1 Hours
Title
Pain intensity difference (PID) at 1.25 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
1.25 Hours
Title
Pain intensity difference (PID) at 1.5 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
1.5 Hours
Title
Pain intensity difference (PID) at 2 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
2 Hours
Title
Pain intensity difference (PID) at 3 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
3 Hours
Title
Pain intensity difference (PID) at 4 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
4 Hours
Title
Pain intensity difference (PID) at 5 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Time Frame
5 Hours
Title
Pain intensity difference (PID) at 6 Hours
Description
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
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:
Are 17 to 50 years of age
Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
Dental extraction of three or four third-molars.
Experience moderate to severe pain after extraction of third molars
Exclusion Criteria:
Currently pregnant (or planning to be pregnant) or nursing a baby
Known allergy to acetaminophen (ACE) 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
Study Director
Organizational Affiliation
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Official's Role
Study Director
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
Undecided
Learn more about this trial
Study of Acetaminophen (ACE) in Post-operative Dental Pain
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