Study to Find Out the Optimal Dose of Caffeine in the Com... | NCT04132336 | Trialant
NCT04132336
Sponsor
Bayer
Status
Completed
Last Update Posted
Sep 1, 2021Actual
Enrollment
193Actual
Phase
Phase 2
Conditions
Pain, Postoperative
Interventions
Naproxen sodium/Caffeine (BAY2880376)
Naproxen sodium (Aleve)
Caffeine
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04132336
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
21069
Secondary IDs
ID
Type
Description
Link
2019-003513-33
EudraCT Number
Brief Title
Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed
Official Title
A Randomized, Double-Blind, Single-Dose, Parallel, Placebo-Controlled Trial to Determine the Dose of Caffeine in a Fixed Dose Combination Tablet of Naproxen Sodium and Caffeine to Effectively Alleviate Postsurgical Dental Pain
Acronym
Not provided
Organization
BayerINDUSTRY
Status Module
Record Verification Date
Aug 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 12, 2019Actual
Primary Completion Date
Mar 2, 2020Actual
Completion Date
Mar 3, 2020Actual
First Submitted Date
Oct 8, 2019
First Submission Date that Met QC Criteria
Oct 17, 2019
First Posted Date
Oct 18, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Mar 31, 2021
Results First Submitted that Met QC Criteria
Jun 14, 2021
Results First Posted Date
Jun 16, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 8, 2021
Last Update Posted Date
Sep 1, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BayerINDUSTRY
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
The researchers in this study wanted to find out the optimal dose of Caffeine in the combination tablet of Naproxen Sodium and Caffeine that works in patients experiencing moderate to severe pain after having wisdom teeth removed. In the US, Naproxen has been marketed since 1976, and Naproxen Sodium has been approved for over-the-counter (OTC) use since 1994 for the temporary relief of minor aches and pains. Caffeine, which is generally consumed as coffee, tea or cocoa, has been shown to enhance the effectiveness of various pain relievers, and therefore is accepted as an additive to painkillers like aspirin and acetaminophen. Patients participating in this study underwent a surgery to remove 3 or 4 wisdom teeth. If the pain severity after the surgery met the study requirement, patients would receive oral tablet(s) of Naproxen Sodium and Caffeine, or Naproxen Sodium, or Caffeine, or placebo (drug with no active ingredient). Patients could also receive additional pain medication when needed. Researchers would also learn if the patients have any medical problems during the study.
Detailed Description
Not provided
Conditions Module
Conditions
Pain, Postoperative
Keywords
Dental pain
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
193Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Naproxen sodium/caffeine - Dose 1
Experimental
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
Drug: Naproxen sodium/Caffeine (BAY2880376)
Naproxen sodium/caffeine - Dose 2
Experimental
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
Drug: Naproxen sodium/Caffeine (BAY2880376)
Naproxen sodium/caffeine - Dose 3
Experimental
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
Drug: Naproxen sodium/Caffeine (BAY2880376)
Naproxen sodium/caffeine - Dose 4
Experimental
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
Drug: Naproxen sodium/Caffeine (BAY2880376)
Naproxen sodium
Active Comparator
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Naproxen sodium/Caffeine (BAY2880376)
Drug
Tablet, oral, single dose
Naproxen sodium/caffeine - Dose 1
Naproxen sodium/caffeine - Dose 2
Naproxen sodium/caffeine - Dose 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Sum of Pain Intensity Difference (SPID) Over 8 Hours
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 8 hours ranges from -80 to 80. A higher value indicates a better pain reduction.
Up to 8 hours post dose
Secondary Outcomes
Measure
Description
Time Frame
Sum of Pain Intensity Differences (SPIDs) From 0 to 2, 4 and 12 Hours Post-dose
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID 0-2 ranges from -20 to 20, SPID 0-4 ranges from -40 to 40 and SPID 0-12 ranges from -120 to 120. A higher value indicates a better pain reduction.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy, ambulatory, male or female volunteers 16 years of age or older;
Body mass index (BMI) 18.5 to 35.0 kg/m^2 inclusive as measured by the National Institutes of Health (NIH) BMI Calculator;
Participants will undergo surgical extraction of three or four third molars, two of which must be mandibular molars. Maxillary third molars may be removed regardless of impaction level. The mandibular extractions must have a trauma rating of mild or moderate and meet one of the following scenarios: two full bony impactions; two partial bony impactions; one full bony impaction in combination with one partial bony impaction. supernumerary teeth present may also be removed at the discretion of the oral surgeon;
Have not taken any form of medication, nutritional supplements with analgesic properties (e.g. gamma-Aminobutyric acid [GABA], turmeric) or herbal supplements (i.e., St. John's Wort) within 5 days of admission (except for oral contraceptives, prophylactic antibiotics, multivitamin supplements, or other routine medications to treat benign conditions (such as antibiotics to treat acne), and agree not to take any medication (other than that provided to them) throughout the study;
Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine) preoperatively, with or without a vasoconstrictor and nitrous oxide at the discretion of the Investigator;
Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of ≥ 5 on the 0-10 pain intensity Numerical Rating Scale (NRS) within 4.5 hours post-surgery.
Exclusion Criteria:
History of hypersensitivity to naproxen sodium, caffeine, ibuprofen, nonsteroidal anti-inflammatory drug (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension and cardiac arrhythmia), hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
Participants with the following medical conditions may be eligible at the discretion of the investigator: attention deficit hyperactivity disorder (ADHD) on a stable dose regimen of methylphenidate/(dextro) amphetamine for at least 6 months; participants with hypothyroidism on a stable dose of synthetic thyroid hormone for at least 6 months;
Have received any form of treatment in the form of medication for depression in the past 6 months or any form of psychotropic agent (including selective serotonin uptake inhibitors [SSRI] but excluding ADHD medications described above) within the last 6 months;
Relevant concomitant disease such as asthma (exercise induced asthma is permitted);
Current or past history of gastrointestinal ulceration, gastrointestinal bleeding or other bleeding disorder(s);
Acute illness or active local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator;
Use of any over-the-counter (OTC) or prescription medications with which the administration of naproxen, acetaminophen, ibuprofen, any other NSAID, (e.g., tramadol) or if a medication is contraindicated;
Use of any medications within 5 days of surgery until discharge from the study site (except oral contraceptives, prophylactic antibiotics, synthetic thyroid hormones, methylphenidate or medications to treat benign conditions such as antibiotics to treat acne);
Use of caffeine within 2 days prior to the study;
Habits of high consumption of caffeine (>400 mg/day equivalent to about 3-4 cups of coffee per day);
Habituation to analgesic drugs including opioids (i.e., routine use of oral analgesics 5 or more times per week for greater than 3 weeks within the past 2 years);
Surgeon's trauma rating of severe following surgery.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
16 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
JBR Clinical Research
Salt Lake City
Utah
84107
United States
References Module
Citations
Not provided
See Also Links
Label
URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 193 participants, including 32 in each of the naproxen sodium containing groups, 16 in the caffeine group, and 17 in the placebo group, underwent dental surgery and were randomized to study drug
Recruitment Details
Study was conducted at a single center in United States with first participant first visit on 12-Nov-2019 and last participant last visit on 02-Mar-2020. Study was completed on 03-Mar-2020 (End of follow up, phone call).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
Drug: Caffeine
Placebo
Placebo Comparator
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Drug: Placebo
Naproxen sodium/caffeine - Dose 4
Naproxen sodium (Aleve)
Drug
Tablet, oral, single dose
Naproxen sodium
Caffeine
Drug
Tablet, oral, single dose
Caffeine
Placebo
Drug
Tablet, oral, single dose
Placebo
Up to 2 hours, 4 hours and 12 hours post dose
Total Pain Relief (TOTPAR) Over 8 Hours
Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 8 hours ranges from 0 to 32, a higher value indicates more pain relief.
Up to 8 hours post dose
Total Pain Relief (TOTPAR) From 0 to 2, 4 and 12 Hours Post-dose
Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR 0-2 ranges from 0 to 8, TOTPAR 0-4 ranges from 0 to 16, and TOTPAR 0-12 ranges from 0 to 48. A higher value indicates more pain relief
Up to 2 hours, 4 hours and 12 hours post dose
Time to First Use of Rescue Medication
Up to 12 hours post dose
The Cumulative Percentage of Participants Taking Rescue Medication
Up to 12 hours post dose
Pain Intensity Difference (PID) at Each Evaluation
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement
Up to 12 hours post dose
Peak Pain Intensity Difference (PID)
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). Participants circle a number (from 0 to 10) on the Numerical Rating Scale to indicate the severity the pain they are experiencing at baseline and at each post dose time point. For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score).
Up to 12 hours post dose
Pain Relief Score at Each Evaluation
Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief)
Up to 12 hours post dose
Peak Pain Relief Score
Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). At each post-dose time point, participants check the appropriate box (from 0 to 4) on the Categorical Pain Relief Rating Scale to indicate the relief from starting pain at the post dose time points.
Up to 12 hours post dose
Global Assessment of the Investigational Product
Global assessment is performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global assessment is based on the question 'Overall, I would rate the study medication I received: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.'
Up to 12 hours post dose
Number of Participants With Adverse Events
Up to 5 days post dose
The Number of Participants With Clinically Significant Changes in Physical Examinations and Vital Signs
Up to 5 days post dose
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
FG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
FG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
FG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
FG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
FG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
FG00032 subjects
FG00132 subjects
FG00232 subjects
FG00332 subjects
FG00432 subjects
FG00516 subjects
FG00617 subjects
COMPLETED
FG00032 subjects
FG00131 subjects
FG00232 subjects
FG00332 subjects
FG00432 subjects
FG00516 subjects
FG00617 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Investigator Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
BG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
BG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
BG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
BG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
BG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
BG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00032
BG00132
BG00232
BG00332
BG00432
BG00516
BG00617
BG007193
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
BG00017.0± 1.03
BG00117.4± 2.42
BG00217.1± 1.34
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00114
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0010
BG002
Baseline Pain Intensity Score
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
No Pain (0)
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
Sum of Pain Intensity Difference (SPID) Over 8 Hours
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 8 hours ranges from -80 to 80. A higher value indicates a better pain reduction.
Posted
Mean
Standard Deviation
Scores on a scale*hours
Up to 8 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
OG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG00035.45± 14.517(14.517 to )
OG00137.87± 16.876(16.876 to )
OG00230.70± 17.679(17.679 to )
Secondary
Sum of Pain Intensity Differences (SPIDs) From 0 to 2, 4 and 12 Hours Post-dose
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID 0-2 ranges from -20 to 20, SPID 0-4 ranges from -40 to 40 and SPID 0-12 ranges from -120 to 120. A higher value indicates a better pain reduction.
Posted
Mean
Standard Deviation
Scores on a scale*hours
Up to 2 hours, 4 hours and 12 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Secondary
Total Pain Relief (TOTPAR) Over 8 Hours
Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 8 hours ranges from 0 to 32, a higher value indicates more pain relief.
Posted
Mean
Standard Deviation
Scores on a scale*hours
Up to 8 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
Secondary
Total Pain Relief (TOTPAR) From 0 to 2, 4 and 12 Hours Post-dose
Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR 0-2 ranges from 0 to 8, TOTPAR 0-4 ranges from 0 to 16, and TOTPAR 0-12 ranges from 0 to 48. A higher value indicates more pain relief
Posted
Mean
Standard Deviation
Scores on a scale*hours
Up to 2 hours, 4 hours and 12 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
Secondary
Time to First Use of Rescue Medication
Posted
Median
Inter-Quartile Range
hours
Up to 12 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
OG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Naproxen Sodium
Secondary
The Cumulative Percentage of Participants Taking Rescue Medication
Posted
Number
Percentage of participants
Up to 12 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
OG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Secondary
Pain Intensity Difference (PID) at Each Evaluation
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement
Posted
Mean
Standard Deviation
Scores on a scale
Up to 12 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
OG003
Naproxen Sodium/Caffeine-Dose 4
Secondary
Peak Pain Intensity Difference (PID)
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). Participants circle a number (from 0 to 10) on the Numerical Rating Scale to indicate the severity the pain they are experiencing at baseline and at each post dose time point. For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score).
Posted
Mean
Standard Deviation
Scores on a scale
Up to 12 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
Secondary
Pain Relief Score at Each Evaluation
Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief)
Posted
Mean
Standard Deviation
Scores on a scale
Up to 12 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
OG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
Secondary
Peak Pain Relief Score
Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). At each post-dose time point, participants check the appropriate box (from 0 to 4) on the Categorical Pain Relief Rating Scale to indicate the relief from starting pain at the post dose time points.
Posted
Mean
Standard Deviation
Scores on a scale
Up to 12 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
OG003
Naproxen Sodium/Caffeine-Dose 4
Secondary
Global Assessment of the Investigational Product
Global assessment is performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global assessment is based on the question 'Overall, I would rate the study medication I received: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.'
Posted
Count of Participants
Participants
Up to 12 hours post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
OG003
Naproxen Sodium/Caffeine-Dose 4
Secondary
Number of Participants With Adverse Events
Posted
Count of Participants
Participants
Up to 5 days post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
OG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Naproxen Sodium
Secondary
The Number of Participants With Clinically Significant Changes in Physical Examinations and Vital Signs
Posted
Count of Participants
Participants
Up to 5 days post dose
ID
Title
Description
OG000
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
OG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
OG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
OG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Time Frame
Up to 5 days post-dose
Description
Not provided
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
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
0
32
0
32
6
32
EG001
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
0
32
0
32
3
32
EG002
Naproxen Sodium/Caffeine-Dose 3
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
0
32
0
32
1
32
EG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
0
32
0
32
2
32
EG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
0
32
0
32
3
32
EG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
0
16
0
16
5
16
EG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
0
17
0
17
4
17
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Tachycardia
Cardiac disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG0030 events0 affected32 at risk
EG0041 events1 affected32 at risk
EG0050 events0 affected16 at risk
EG0060 events0 affected17 at risk
Ear pain
Ear and labyrinth disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Chest discomfort
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Feeling hot
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Alveolar osteitis
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0005 events2 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Other pre-specified outcomes (non-key secondary) "Time to first perceptible relief/meaningful relief/perceptible relief confirmed by meaningful relief" and "Cumulative percentage of subjects with at least '2-point PID' over time" were also analyzed
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
OG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG00332
OG00432
OG00516
OG00616
Title
Denominators
Categories
SPID 0-2
Title
Measurements
OG0008.30± 3.141(3.141 to )
OG0018.68± 3.789(3.789 to )
OG0027.17± 3.721(3.721 to )
OG0036.92± 3.501(3.501 to )
OG0046.05± 3.511(3.511 to )
OG0052.13± 4.060(4.060 to )
OG0061.16± 2.925(2.925 to )
SPID 0-4
Title
Measurements
OG00018.02± 6.387(6.387 to )
OG00119.26± 8.019(8.019 to )
OG00215.58± 7.697(7.697 to )
OG003
SPID 0-12
Title
Measurements
OG00050.58± 24.237(24.237 to )
OG00152.45± 27.305(27.305 to )
OG00244.80± 28.929(28.929 to )
OG003
OG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG00332
OG00432
OG00516
OG00616
Title
Denominators
Categories
Title
Measurements
OG00019.58± 7.007(7.007 to )
OG00120.26± 7.673(7.673 to )
OG00217.41± 8.063(8.063 to )
OG00319.53± 6.448(6.448 to )
OG00416.27± 8.514(8.514 to )
OG0057.03± 9.283(9.283 to )
OG0065.44± 7.709(7.709 to )
OG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG00332
OG00432
OG00516
OG00616
Title
Denominators
Categories
TOTPAR 0-2
Title
Measurements
OG0004.83± 1.401(1.401 to )
OG0014.77± 1.731(1.731 to )
OG0024.22± 1.596(1.596 to )
OG0033.97± 1.436(1.436 to )
OG0043.52± 1.644(1.644 to )
OG0051.66± 1.767(1.767 to )
OG0061.06± 1.328(1.328 to )
TOTPAR 0-4
Title
Measurements
OG00010.27± 2.750(2.750 to )
OG00110.29± 3.449(3.449 to )
OG0028.84± 3.286(3.286 to )
OG003
TOTPAR 0-12
Title
Measurements
OG00028.20± 12.262(12.262 to )
OG00128.26± 12.690(12.690 to )
OG00225.13± 13.291(13.291 to )
OG003
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG00332
OG00432
OG00516
OG00616
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA= insufficient number of participants with events
OG001NA(8.967 to NA)NA= insufficient number of participants with events
OG002NA(8.817 to NA)NA= insufficient number of participants with events
OG003NA(NA to NA)NA= insufficient number of participants with events
OG004NA(8.125 to NA)NA= insufficient number of participants with events
OG0052.083(1.275 to NA)NA= insufficient number of participants with events
OG0062.125(1.408 to NA)NA= insufficient number of participants with events
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG00332
OG00432
OG00516
OG00616
Title
Denominators
Categories
0.5 Hours Post-Dose
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
1 Hour Post-Dose
Title
Measurements
OG0000
OG0010
OG0020
OG003
1.5 Hours Post-Dose
Title
Measurements
OG0000
OG0013.2
OG0023.1
OG003
2 Hours Post-Dose
Title
Measurements
OG0000
OG0013.2
OG0023.1
OG003
3 Hours Post-Dose
Title
Measurements
OG0000
OG0016.5
OG0026.3
OG003
4 Hours Post-Dose
Title
Measurements
OG0003.1
OG0016.5
OG0029.4
OG003
5 Hours Post-Dose
Title
Measurements
OG0009.4
OG0016.5
OG00215.6
OG003
6 Hours Post-Dose
Title
Measurements
OG0009.4
OG0019.7
OG00218.8
OG003
7 Hours Post-Dose
Title
Measurements
OG00012.5
OG0019.7
OG00221.9
OG003
8 Hours Post-Dose
Title
Measurements
OG00015.6
OG0019.7
OG00221.9
OG003
9 Hours Post-Dose
Title
Measurements
OG00021.9
OG00125.8
OG00225.0
OG003
10 Hours Post-Dose
Title
Measurements
OG00025.0
OG00125.8
OG00228.1
OG003
11 Hours Post-Dose
Title
Measurements
OG00025.0
OG00125.8
OG00228.1
OG003
12 Hours Post-Dose
Title
Measurements
OG00025.0
OG00129.0
OG00228.1
OG003
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG00331
OG00432
OG00516
OG00616
Title
Denominators
Categories
0.5 Hours Post-Dose
Title
Measurements
OG0002.3± 2.07
OG0012.6± 1.82
OG0022.1± 2.23
OG0031.4± 1.56
OG0041.5± 1.34
OG0050.8± 0.98
OG0060.5± 0.89
1 Hour Post-Dose
Title
Measurements
OG0004.2± 1.88
OG0014.2± 2.44
OG0023.7± 1.95
OG003
1.5 Hours Post-Dose
Title
Measurements
OG0004.9± 1.67
OG0015.1± 2.26
OG0024.3± 1.98
OG003
2 Hours Post-Dose
Title
Measurements
OG0005.1± 1.76
OG0015.5± 2.20
OG0024.3± 2.23
OG003
3 Hours Post-Dose
Title
Measurements
OG0005.0± 1.82
OG0015.4± 2.27
OG0024.3± 2.33
OG003
4 Hours Post-Dose
Title
Measurements
OG0004.8± 2.17
OG0015.2± 2.59
OG0024.1± 2.62
OG003
5 Hours Post-Dose
Title
Measurements
OG0004.7± 2.28
OG0015.0± 2.42
OG0024.0± 2.72
OG003
6 Hours Post-Dose
Title
Measurements
OG0004.6± 2.24
OG0014.8± 2.42
OG0023.8± 2.87
OG003
7 Hours Post-Dose
Title
Measurements
OG0004.3± 2.55
OG0014.5± 2.45
OG0023.8± 3.07
OG003
8 Hours Post-Dose
Title
Measurements
OG0004.0± 2.53
OG0014.2± 2.65
OG0023.7± 3.12
OG003
9 Hours Post-Dose
Title
Measurements
OG0003.8± 2.71
OG0013.8± 3.12
OG0023.6± 3.00
OG003
10 Hours Post-Dose
Title
Measurements
OG0003.8± 2.88
OG0013.7± 3.04
OG0023.4± 3.15
OG003
11 Hours Post-Dose
Title
Measurements
OG0003.8± 2.92
OG0013.5± 3.02
OG0023.6± 3.17
OG003
12 Hours Post-Dose
Title
Measurements
OG0003.8± 2.97
OG0013.6± 3.06
OG0023.5± 3.38
OG003
OG003
Naproxen Sodium/Caffeine-Dose 4
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG00332
OG00432
OG00516
OG00616
Title
Denominators
Categories
Title
Measurements
OG0006.0± 1.53(1.53 to )
OG0016.2± 1.97(1.97 to )
OG0025.9± 2.01(2.01 to )
OG0036.3± 1.72(1.72 to )
OG0045.3± 2.57(2.57 to )
OG0052.7± 2.94(2.94 to )
OG0062.3± 2.98(2.98 to )
OG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG00332
OG00432
OG00516
OG00616
Title
Denominators
Categories
0.5 Hours Post-Dose
Title
Measurements
OG0001.6± 1.08(1.08 to )
OG0011.5± 0.89(0.89 to )
OG0021.5± 1.02(1.02 to )
OG0030.9± 0.80(0.80 to )
OG0041.0± 0.74(0.74 to )
OG0050.6± 0.62(0.62 to )
OG0060.4± 0.63(0.63 to )
1 Hours Post-Dose
Title
Measurements
OG0002.4± 0.84(0.84 to )
OG0012.3± 1.22(1.22 to )
OG0022.2± 0.91(0.91 to )
OG003
1.5 Hours Post-Dose
Title
Measurements
OG0002.8± 0.64(0.64 to )
OG0012.8± 0.99(0.99 to )
OG0022.3± 0.87(0.87 to )
OG003
2 Hours Post-Dose
Title
Measurements
OG0002.8± 0.85(0.85 to )
OG0012.9± 1.01(1.01 to )
OG0022.4± 1.01(1.01 to )
OG003
3 Hours Post-Dose
Title
Measurements
OG0002.8± 0.79(0.79 to )
OG0012.8± 0.97(0.97 to )
OG0022.4± 1.04(1.04 to )
OG003
4 Hours Post-Dose
Title
Measurements
OG0002.7± 1.07(1.07 to )
OG0012.7± 1.19(1.19 to )
OG0022.3± 1.16(1.16 to )
OG003
5 Hours Post-Dose
Title
Measurements
OG0002.6± 1.16(1.16 to )
OG0012.6± 1.15(1.15 to )
OG0022.3± 1.27(1.27 to )
OG003
6 Hours Post-Dose
Title
Measurements
OG0002.4± 1.16(1.16 to )
OG0012.6± 1.18(1.18 to )
OG0022.2± 1.35(1.35 to )
OG003
7 Hours Post-Dose
Title
Measurements
OG0002.3± 1.34(1.34 to )
OG0012.5± 1.15(1.15 to )
OG0022.1± 1.38(1.38 to )
OG003
8 Hours Post-Dose
Title
Measurements
OG0002.1± 1.33(1.33 to )
OG0012.3± 1.28(1.28 to )
OG0022.1± 1.46(1.46 to )
OG003
9 Hours Post-Dose
Title
Measurements
OG0002.2± 1.40(1.40 to )
OG0012.1± 1.48(1.48 to )
OG0022.0± 1.45(1.45 to )
OG003
10 Hours Post-Dose
Title
Measurements
OG0002.2± 1.51(1.51 to )
OG0012.0± 1.43(1.43 to )
OG0021.8± 1.42(1.42 to )
OG003
11 Hours Post-Dose
Title
Measurements
OG0002.1± 1.52(1.52 to )
OG0011.9± 1.40(1.40 to )
OG0021.9± 1.48(1.48 to )
OG003
12 Hours Post-Dose
Title
Measurements
OG0002.2± 1.55(1.55 to )
OG0011.9± 1.46(1.46 to )
OG0022.0± 1.51(1.51 to )
OG003
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG00332
OG00432
OG00516
OG00616
Title
Denominators
Categories
Title
Measurements
OG0003.3± 0.62(0.62 to )
OG0013.2± 0.78(0.78 to )
OG0023.0± 0.82(0.82 to )
OG0033.1± 0.66(0.66 to )
OG0042.6± 1.01(1.01 to )
OG0051.6± 1.55(1.55 to )
OG0061.3± 1.39(1.39 to )
Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
OG004
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00131
OG00232
OG00332
OG00432
OG00516
OG00616
Title
Denominators
Categories
Title
Measurements
Poor (0)
OG0001
OG0011
OG0021
OG0031
OG0044
OG0058
OG00610
Fair (1)
OG0002
OG0011
OG0024
OG0032
OG004
Good (2)
OG0005
OG0016
OG0029
OG0037
OG004
Very Good (3)
OG00018
OG00114
OG00213
OG00317
OG004
Excellent (4)
OG0006
OG0019
OG0025
OG0035
OG004
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
Units
Counts
Participants
OG00032
OG00132
OG00232
OG00332
OG00432
OG00516
OG00617
Title
Denominators
Categories
Title
Measurements
OG0006
OG0013
OG0021
OG0032
OG0043
OG0055
OG0064
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
OG005
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
OG006
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars