Acetaminophen/Naproxen Sodium Dose Ranging Study | NCT04447040 | Trialant
NCT04447040
Sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Status
Completed
Last Update Posted
Mar 24, 2025Actual
Enrollment
304Actual
Phase
Phase 2
Conditions
Pain
Interventions
Acetaminophen/naproxen sodium Dose A
Acetaminophen/naproxen sodium Dose B
Acetaminophen/naproxen sodium Dose C
Acetaminophen/naproxen sodium Dose D
Acetaminophen/naproxen sodium Dose E
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04447040
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CCSPAA002398
Secondary IDs
Not provided
Brief Title
Acetaminophen/Naproxen Sodium Dose Ranging Study
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain
Acronym
Not provided
Organization
Johnson & Johnson Consumer and Personal Products WorldwideINDUSTRY
Status Module
Record Verification Date
Mar 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Nov 9, 2020Actual
Primary Completion Date
Apr 9, 2021Actual
Completion Date
May 3, 2021Actual
First Submitted Date
Jun 23, 2020
First Submission Date that Met QC Criteria
Jun 23, 2020
First Posted Date
Jun 25, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Mar 14, 2024
Results First Submitted that Met QC Criteria
Mar 14, 2024
Results First Posted Date
Apr 11, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 6, 2022
Certification/Extension First Submitted that Passed QC Review
Apr 6, 2022
Certification/Extension First Posted Date
Apr 8, 2022Actual
Last Update Submitted Date
Mar 14, 2025
Last Update Posted Date
Mar 24, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.
Detailed Description
This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:[Acetaminophen/Naproxen Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C, Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo] following surgical extraction of four third molars.
Conditions Module
Conditions
Pain
Keywords
Analgesics
Dental Pain
Acetaminophen
Naproxen Sodium
Pain
Fixed-Dose
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
304Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Acetaminophen/naproxen sodium Dose A
Experimental
Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose A
Acetaminophen/naproxen sodium Dose B
Experimental
Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose B
Acetaminophen/naproxen sodium Dose C
Experimental
Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose C
Acetaminophen/naproxen sodium Dose D
Experimental
Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose D
Acetaminophen/naproxen sodium Dose E
Experimental
Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose E
Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Acetaminophen/naproxen sodium Dose A
Drug
Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
Time weighted sum of the pain intensity difference (SPID) score is derived from pain intensity difference (PID) score. Pain intensity-numerical rating scale (PI-NRS) was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID score was the difference between baseline pain intensity and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the interval from 0 to 12 hours. The possible range of SPID for 0 to 12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief.
Baseline (0 hour) up to 12 hours post-dose on Day 1
Secondary Outcomes
Measure
Description
Time Frame
Time Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
Time weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0 to10 (0 = no relief, 10 = complete relief). A higher score indicated greater pain relief. Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores were indicative of more pain relief.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males or females 17-50 years old
Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
Surgical removal of three or four third molars, of which, two must be mandibular impactions
Meets requirements for post-surgical pain level
Females of childbearing potential and males agree to contraceptive requirements of study
Have a negative urine drug screen at screening, and on day of surgical procedure
Exclusion Criteria:
Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, oxycodone or other opioids;
Not able to swallow whole large tablets or capsules
History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
Use analgesics 5 or more times per week
History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years
Use of any immunosuppressive drugs within 2 weeks of screening
History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
17 Years
Maximum Age
50 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Todd Bertoch, MD
JBR Clinical Research
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
JBR Clinical Research
Salt Lake City
Utah
84107
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
FG001
Acetaminophen/Naproxen Sodium Dose A
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 25, 2020
Mar 14, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Post-operative dental pain following third molar extraction.
Placebo tablets administered as a single two-tablet dose.
Drug: Placebo
Acetaminophen/naproxen sodium Dose B
Drug
Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose B
Acetaminophen/naproxen sodium Dose C
Drug
Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose C
Acetaminophen/naproxen sodium Dose D
Drug
Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose D
Acetaminophen/naproxen sodium Dose E
Drug
Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose E
Placebo
Drug
Placebo tablets administered as a single two-tablet dose.
Placebo
Baseline (0 hour) up to 12 hours post-dose on Day 1
Time Weighted Sum of Pain Intensity Difference Score From 6 Hours to 12 Hours (SPID 6-12)
Time weighted sum of the pain intensity difference (SPID) score is derived from PID score. PI-NRS was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID was the difference between pain intensity at 6 hours and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the intervals from 6 to 12 hours (6 hours). The possible range of SPID for 6 to12 hours was from -60 to 60. A higher value of SPID indicated greater pain relief.
From 6 hours up to 12 hours post-dose on Day 1
Time to First Use of Rescue Analgesic Medication
Time to first use of rescue analgesic medication was measured as the elapsed time (in minutes) from when the investigational product was given until the time rescue analgesic was first given. Participants who did not use rescue medication during the 24 hour study period had their time to rescue set to 24 hours and were censored at 24 hours. Kaplan-Meier method was used for the analysis.
From 0 minute up to 1440 minutes post-dose (that is, up to 24 hours post-dose) on Day 1
Proportion of Participants Who Required Rescue Analgesic Medication
Proportion (cumulative data) of participants who used rescue analgesic medication through 24 hours post study drug administration on Day 1 which was assessed by using Kaplan-Meier estimates were reported.
From 0 hour up to 24 hours post-dose on Day 1
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
FG002
Acetaminophen/Naproxen Sodium Dose B
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
FG003
Acetaminophen/Naproxen Sodium Dose C
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
FG004
Acetaminophen/Naproxen Sodium Dose D
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
FG005
Acetaminophen/Naproxen Sodium Dose E
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
FG00053 subjects
FG00149 subjects
FG00253 subjects
FG00352 subjects
FG00451 subjects
FG00546 subjects
COMPLETED
FG00051 subjects
FG00147 subjects
FG00249 subjects
FG00348 subjects
FG00450 subjects
FG00543 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0024 subjects
FG0034 subjects
FG0041 subjects
FG0053 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0033 subjects
FG0041 subjects
FG0053 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
BG001
Acetaminophen/Naproxen Sodium Dose A
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
BG002
Acetaminophen/Naproxen Sodium Dose B
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
BG003
Acetaminophen/Naproxen Sodium Dose C
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
BG004
Acetaminophen/Naproxen Sodium Dose D
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
BG005
Acetaminophen/Naproxen Sodium Dose E
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00053
BG00149
BG00253
BG00352
BG00451
BG00546
BG006304
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00018.5± 1.78
BG00118.4± 1.83
BG00218.6± 2.05
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00025
BG00127
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00012
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
Time weighted sum of the pain intensity difference (SPID) score is derived from pain intensity difference (PID) score. Pain intensity-numerical rating scale (PI-NRS) was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID score was the difference between baseline pain intensity and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the interval from 0 to 12 hours. The possible range of SPID for 0 to 12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief.
Intent-to-Treat (ITT) analysis set included all randomized participants.
Posted
Least Squares Mean
Standard Deviation
Units on a scale
Baseline (0 hour) up to 12 hours post-dose on Day 1
ID
Title
Description
OG000
Placebo
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
OG001
Acetaminophen/Naproxen Sodium Dose A
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
OG002
Acetaminophen/Naproxen Sodium Dose B
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
OG003
Acetaminophen/Naproxen Sodium Dose C
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
OG004
Acetaminophen/Naproxen Sodium Dose D
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
OG005
Acetaminophen/Naproxen Sodium Dose E
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
Units
Counts
Participants
OG00053
OG00149
OG00253
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.59± 3.741
OG00137.08± 3.892
OG00246.98± 3.740
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
<0.001
Least square (LS) Mean Difference
31.48
Standard Error of the Mean
5.379
2-Sided
95
20.90
42.07
Superiority
OG000
OG002
ANOVA
<0.001
Secondary
Time Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
Time weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0 to10 (0 = no relief, 10 = complete relief). A higher score indicated greater pain relief. Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores were indicative of more pain relief.
ITT analysis set included all randomized participants.
Posted
Least Squares Mean
Standard Deviation
Units on a scale
Baseline (0 hour) up to 12 hours post-dose on Day 1
ID
Title
Description
OG000
Placebo
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
OG001
Acetaminophen/Naproxen Sodium Dose A
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
OG002
Acetaminophen/Naproxen Sodium Dose B
Secondary
Time Weighted Sum of Pain Intensity Difference Score From 6 Hours to 12 Hours (SPID 6-12)
Time weighted sum of the pain intensity difference (SPID) score is derived from PID score. PI-NRS was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID was the difference between pain intensity at 6 hours and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the intervals from 6 to 12 hours (6 hours). The possible range of SPID for 6 to12 hours was from -60 to 60. A higher value of SPID indicated greater pain relief.
ITT analysis set included all randomized participants.
Posted
Least Squares Mean
Standard Deviation
Units on a scale
From 6 hours up to 12 hours post-dose on Day 1
ID
Title
Description
OG000
Placebo
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
OG001
Acetaminophen/Naproxen Sodium Dose A
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
Secondary
Time to First Use of Rescue Analgesic Medication
Time to first use of rescue analgesic medication was measured as the elapsed time (in minutes) from when the investigational product was given until the time rescue analgesic was first given. Participants who did not use rescue medication during the 24 hour study period had their time to rescue set to 24 hours and were censored at 24 hours. Kaplan-Meier method was used for the analysis.
ITT analysis set included all randomized participants.
Posted
Median
Full Range
Minutes
From 0 minute up to 1440 minutes post-dose (that is, up to 24 hours post-dose) on Day 1
ID
Title
Description
OG000
Placebo
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
OG001
Acetaminophen/Naproxen Sodium Dose A
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
OG002
Acetaminophen/Naproxen Sodium Dose B
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
Secondary
Proportion of Participants Who Required Rescue Analgesic Medication
Proportion (cumulative data) of participants who used rescue analgesic medication through 24 hours post study drug administration on Day 1 which was assessed by using Kaplan-Meier estimates were reported.
ITT analysis set included all randomized participants.
Posted
Number
95% Confidence Interval
Proportion of participants
From 0 hour up to 24 hours post-dose on Day 1
ID
Title
Description
OG000
Placebo
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
OG001
Acetaminophen/Naproxen Sodium Dose A
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
OG002
Acetaminophen/Naproxen Sodium Dose B
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
Time Frame
From baseline (Day 1; day of surgery) up to Day 10
Description
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
0
53
0
53
12
53
EG001
Acetaminophen/Naproxen Sodium Dose A
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
0
49
0
49
7
49
EG002
Acetaminophen/Naproxen Sodium Dose B
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
0
53
0
53
6
53
EG003
Acetaminophen/Naproxen Sodium Dose C
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
0
52
0
52
5
52
EG004
Acetaminophen/Naproxen Sodium Dose D
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
0
51
0
51
3
51
EG005
Acetaminophen/Naproxen Sodium Dose E
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
0
46
0
46
3
46
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0009 affected53 at risk
EG0015 affected49 at risk
EG0022 affected53 at risk
EG0032 affected52 at risk
EG0042 affected51 at risk
EG0051 affected46 at risk
Vomiting
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0006 affected53 at risk
EG0011 affected49 at risk
EG0022 affected53 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected53 at risk
EG0011 affected49 at risk
EG0021 affected53 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected53 at risk
EG0011 affected49 at risk
EG0020 affected53 at risk
EG003
Alveolar osteitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected53 at risk
EG0010 affected49 at risk
EG0021 affected53 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected53 at risk
EG0010 affected49 at risk
EG0020 affected53 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected53 at risk
EG0010 affected49 at risk
EG0021 affected53 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected53 at risk
EG0010 affected49 at risk
EG0020 affected53 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected53 at risk
EG0010 affected49 at risk
EG0020 affected53 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected53 at risk
EG0010 affected49 at risk
EG0020 affected53 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected53 at risk
EG0010 affected49 at risk
EG0021 affected53 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected53 at risk
EG0010 affected49 at risk
EG0020 affected53 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected53 at risk
EG0011 affected49 at risk
EG0020 affected53 at risk
EG003
Pyrexia
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected53 at risk
EG0010 affected49 at risk
EG0020 affected53 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Publication of study results by the Investigator is discussed in the Clinical Study Agreement, as appropriate. Results from this study may be published in the form of oral or written presentations at scientific meetings or as one or more peer-reviewed journal articles. In these cases, no information on individual subjects will be revealed.
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
OG003
Acetaminophen/Naproxen Sodium Dose C
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
OG004
Acetaminophen/Naproxen Sodium Dose D
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
OG005
Acetaminophen/Naproxen Sodium Dose E
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
Units
Counts
Participants
OG00053
OG00149
OG00253
OG00352
OG00451
OG00546
Title
Denominators
Categories
Title
Measurements
OG00018.40± 4.550
OG00154.06± 4.734
OG00267.45± 4.548
OG00372.04± 4.597
OG00479.33± 4.637
OG00585.98± 4.898
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
<0.001
LS Mean Difference
35.66
Standard Error of the Mean
6.542
2-Sided
95
22.79
48.54
Superiority
OG000
OG002
ANOVA
<0.001
LS Mean Difference
49.04
Standard Error of the Mean
6.407
2-Sided
95
36.44
61.65
Superiority
OG000
OG003
ANOVA
<0.001
LS Mean Difference
53.64
Standard Error of the Mean
6.437
2-Sided
95
40.97
66.31
Superiority
OG000
OG004
ANOVA
<0.001
LS Mean Difference
60.93
Standard Error of the Mean
6.472
2-Sided
95
48.19
73.67
Superiority
OG000
OG005
ANOVA
<0.001
LS Mean Difference
67.58
Standard Error of the Mean
6.650
2-Sided
95
54.49
80.67
Superiority
OG002
Acetaminophen/Naproxen Sodium Dose B
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
OG003
Acetaminophen/Naproxen Sodium Dose C
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
OG004
Acetaminophen/Naproxen Sodium Dose D
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
OG005
Acetaminophen/Naproxen Sodium Dose E
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
Units
Counts
Participants
OG00053
OG00149
OG00253
OG00352
OG00451
OG00546
Title
Denominators
Categories
Title
Measurements
OG0002.58± 2.154
OG00115.12± 2.241
OG00220.31± 2.153
OG00324.47± 2.176
OG00427.59± 2.195
OG00531.89± 2.318
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA
<0.001
LS mean Difference
12.53
Standard Error of the Mean
3.097
2-Sided
95
6.44
18.63
Superiority
OG000
OG002
ANOVA
<0.001
LS MEAN Difference
17.73
Standard Error of the Mean
3.032
2-Sided
95
11.76
23.70
Superiority
OG000
OG003
ANOVA
<0.001
LS Mean Difference
21.88
Standard Error of the Mean
3.047
2-Sided
95
15.89
27.88
Superiority
OG000
OG004
ANOVA
<0.001
LS Mean Difference
25.01
Standard Error of the Mean
3.063
2-Sided
95
18.98
31.03
Superiority
OG000
OG005
ANOVA
<0.001
LS Mean Difference
29.30
Standard Error of the Mean
3.148
2-Sided
95
23.11
35.50
Superiority
OG003
Acetaminophen/Naproxen Sodium Dose C
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
OG004
Acetaminophen/Naproxen Sodium Dose D
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
OG005
Acetaminophen/Naproxen Sodium Dose E
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
Units
Counts
Participants
OG00053
OG00149
OG00253
OG00352
OG00451
OG00546
Title
Denominators
Categories
Title
Measurements
OG00090.0(38 to 1440)
OG001898.0(33 to 1440)
OG0021195.0(30 to 1440)
OG003NA(0 to 1440)Median was not estimable because fewer than 50% of participants required rescue medication.
OG004NA(68 to 1440)Median was not estimable because fewer than 50% of participants required rescue medication.
OG005NA(497 to 1440)Median was not estimable because fewer than 50% of participants required rescue medication.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon test
<0.001
Superiority
OG000
OG002
Wilcoxon test
<0.001
Superiority
OG000
OG003
Wilcoxon test
<0.001
Superiority
OG000
OG004
Wilcoxon test
<0.001
Superiority
OG000
OG005
Wilcoxon test
<0.001
Superiority
OG003
Acetaminophen/Naproxen Sodium Dose C
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
OG004
Acetaminophen/Naproxen Sodium Dose D
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
OG005
Acetaminophen/Naproxen Sodium Dose E
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.