Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium a... | NCT01280591

Status Module

Label	Type	Intervention Names
Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)	Experimental	Drug: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)
Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)	Experimental	Drug: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)
Naproxen sodium 440 mg (BAYH6689)	Active Comparator	Drug: Naproxen sodium 440 mg (BAYH6689)
DPH 50 mg	Active Comparator	Drug: DPH 50 mg

Name	Type	Description	Arm Group Labels	Other Names
Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)	Drug	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose	Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wake Time After Sleep Onset (WASO) Measured by Actigraphy	WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.	Up to 10 hours
Sleep Latency Measured by Actigraphy	Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.	Up to 10 hours

Secondary Outcomes

Measure	Description	Time Frame
Total Sleep Time Measured by Actigraphy	Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.	Up to 10 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, ambulatory, male and female volunteers ages 12 and older
Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:
- one full bony impaction
- two partial bony impactions
- one full bony impaction and one partial bony impaction
- one full bony impaction and one soft tissue impaction
- one full bony impaction and one erupted third molar. Two full bony mandibular impactions are not allowed. Maxillary third molars may be removed regardless of impaction level.
Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of ≥ 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600 hour and 1830 hour on the day of surgery
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects <18 years of age must sign a written assent and have parental or guardian consent).

Exclusion Criteria:

History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal anti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years
Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator
Current or past history of bleeding disorder(s)
Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator
Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months
Positive alcohol breathalyzer test and positive urine drug test prior to surgery
Females who are pregnant or lactating
Chronic or severe sleep problems that do not respond to / Over the Counter (OTC) medication and requires a prescription hypnotic or sedative
Habitually spends less than 6.5 hours in bed

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

PubMed Identifier	Type	Citation	Retractions
25996289	Derived	Cooper S, Laurora I, Wang Y, Venkataraman P, An R, Roth T. Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia. Int J Clin Pract. 2015 Oct;69(10):1149-58. doi: 10.1111/ijcp.12669. Epub 2015 May 21.

ID	Title	Description
FG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
FG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)

ID	Title	Description
BG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
BG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
BG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
BG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG000203 BG001204 BG002203 BG003102 BG004712

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

Wake Time After Sleep Onset (WASO) Measured by Actigraphy

WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.

ITT (Intent to Treat) Population

Posted

Least Squares Mean

95% Confidence Interval

Minutes

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Units	Counts
Participants	OG000203 OG001204 OG002203 OG003

Title

Denominators

Categories

Title	Measurements
	OG000143.7(117.9 to 169.6) OG001230.9(205.2 to 256.5) OG002214.0(188.2 to 239.8) 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 OG002		ANCOVA		0.0002		Mean Difference (Final Values)	-70.3	Standard Error of the Mean	13.17	2-Sided	95	-106.8	-33.7				No	Superiority or Other

Primary

Sleep Latency Measured by Actigraphy

Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.

ITT (Intent to Treat) Population

Posted

Median

95% Confidence Interval

Minutes

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Total Sleep Time Measured by Actigraphy

Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.

ITT (Intent to Treat) Population

Posted

Least Squares Mean

95% Confidence Interval

Minutes

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg

Secondary

Sleep Efficiency Measured by Actigraphy

Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.

ITT (Intent to Treat) Population

Posted

Least Squares Mean

95% Confidence Interval

Percent of sleep time during in-bed time

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg

Secondary

Global Assessment of Investigational Product as a Sleep Aid

The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Number

Participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Karolinska Sleep Diary - Sleep Quality

Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Number

Participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Karolinska Sleep Diary - Calmness of Sleep

Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Number

Participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Karolinska Sleep Diary - Easiness to Fall Asleep

Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Number

Participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Karolinska Sleep Diary - Premature Awakening

Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Number

Participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Karolinska Sleep Diary - Ease of Awakening

Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Number

Participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Karolinska Sleep Diary - Well Rested

Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Number

Participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Karolinska Sleep Diary - Sufficient Sleep

Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Number

Participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Subjective Sleep Questionnaire - Quality of Your Sleep Last Night

Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Mean

Standard Deviation

Scores on a scale

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night

Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Mean

Standard Deviation

Scores on a scale

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Subjective Sleep Questionnaire - Time to Fall Asleep Last Night

Subjects responded to Estimate of how long it took to fall asleep (minutes)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Mean

Standard Deviation

Minutes

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed

Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Mean

Standard Deviation

Minutes

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg

Secondary

Change From Baseline in Pain Intensity

Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain

ITT (Intent to Treat) Population

Posted

Mean

Standard Deviation

Scores on a scale

Baseline and up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Overall Rating of Pain Relief

The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement "Overall, the relief from my starting pain was": no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4).

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Number

Participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg

Secondary

Time to Rescue Medication

If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded

ITT (Intent to Treat) Population

Posted

Median

95% Confidence Interval

Minutes

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Cumulative Proportion of Subjects Taking Rescue Medication by Hour

If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded

Safety Population

Posted

Number

participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Secondary

Global Assessment of Investigational Product as a Pain Reliever

The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).

ITT (Intent to Treat) Population with available data (missing values were not imputed)

Posted

Number

Participants

Up to 10 hours

ID	Title	Description
OG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
OG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
OG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose
OG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0011 affected204 at risk EG0021 affected203 at risk EG0030 affected102 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0020 affected203 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG00015 affected203 at risk EG00112 affected204 at risk EG00214 affected203 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected203 at risk EG0015 affected204 at risk EG0026 affected203 at risk EG003
Chills	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected203 at risk EG0010 affected204 at risk EG0020 affected203 at risk EG003
Feeling cold	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Feeling hot	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected203 at risk EG0011 affected204 at risk EG0021 affected203 at risk EG003
Pyrexia	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected203 at risk EG0011 affected204 at risk EG0020 affected203 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0011 affected204 at risk EG0020 affected203 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0020 affected203 at risk EG003
Dizziness	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0009 affected203 at risk EG0017 affected204 at risk EG0025 affected203 at risk EG003
Headache	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG00012 affected203 at risk EG00113 affected204 at risk EG00215 affected203 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Presyncope	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected203 at risk EG0013 affected204 at risk EG0022 affected203 at risk EG003
Syncope	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected203 at risk EG0010 affected204 at risk EG0022 affected203 at risk EG003
Tremor	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected203 at risk EG0010 affected204 at risk EG0020 affected203 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0011 affected204 at risk EG0023 affected203 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0020 affected203 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected203 at risk EG0010 affected204 at risk EG0020 affected203 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected203 at risk EG0010 affected204 at risk EG0020 affected203 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected203 at risk EG0010 affected204 at risk EG0020 affected203 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected203 at risk EG0010 affected204 at risk EG0021 affected203 at risk EG003
Flushing	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected203 at risk EG0010 affected204 at risk EG0020 affected203 at risk EG003
Hypertension	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected203 at risk EG0011 affected204 at risk EG0020 affected203 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Austin	Texas	78744	United States

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D009280	Naphthaleneacetic Acids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose	203	37	203
EG001	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose	204	37	204
EG002	Naproxen Sodium 440 mg (BAYH6689)	Participants received two Naproxen sodium 220 mg tablets orally, single dose	203	40	203
EG003	DPH 50 mg	Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose	102	25	102