Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium... | NCT01495858

NCT01495858

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)	Experimental	Drug: Naproxen Sodium 440 mg / DPH 25 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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)	Drug	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.

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 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

Other Outcomes

Measure	Description	Time Frame
Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2		Baseline and day 2
Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2		Baseline and Day 2

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 non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.

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

Contacts/Locations Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

References Module

Citations

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.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
FG001	Naproxen Sodium 440 mg (BAYH6689)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)

Type of Units Analyzed

Arm/Group Information

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

Units	Counts
Participants	BG000107 BG001106 BG00254 BG003267

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
	BG00021.4± 5.55 BG00121.3± 5.27 BG00220.8± 4.64 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00072 BG00164 BG002

Baseline Categorical Pain Rating Scale

Number

Participants

Title

Denominators

Categories

No pain

Title	Measurements
	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

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants	OG000107 OG001106 OG00254

Title

Denominators

Categories

Title	Measurements
	OG000155.25(121.57 to 188.93) OG001180.08(146.36 to 213.80) OG002364.83(317.52 to 412.15)

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		ANCOVA		0.3047													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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts

Secondary

Total Sleep Time Measured by Actigraphy

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts

Secondary

Subjective Sleep Questionnaire - Quality of Your Sleep Last Night

Subject evaluated sleep quality on a 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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

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

Posted

Number

Participants

Up to 10 hours

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

Units	Counts

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

Secondary

Cumulative Proportion of Participants 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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts
Participants

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 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
OG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
OG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Units	Counts

Other Pre-specified

Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2

Safety Population

Posted

Mean

Standard Deviation

mmHg

Baseline and day 2

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

Units	Counts
Participants	OG000

Other Pre-specified

Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2

Safety Population

Posted

Mean

Standard Deviation

mmHg

Baseline and Day 2

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

Units	Counts
Participants	OG000

Other Pre-specified

Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2

Safety Population

Posted

Mean

Standard Deviation

Beats/min

Baseline and day 2

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

Units	Counts
Participants	OG000

Other Pre-specified

Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2

Safety Population

Posted

Mean

Standard Deviation

Breaths/min

Baseline and day 2

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

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)	Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally	107	21	107
EG001	Naproxen Sodium 440 mg (BAYH6689)	Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally	106	14	106
EG002	DPH 50 mg	Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.	54	17	54

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Deafness	Ear and labyrinth disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected107 at risk EG0010 affected106 at risk EG0020 affected54 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected107 at risk EG0011 affected106 at risk EG0020 affected54 at risk
Vision blurred	Eye disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected107 at risk EG0010 affected106 at risk EG0021 affected54 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0006 affected107 at risk EG0014 affected106 at risk EG0022 affected54 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected107 at risk EG0010 affected106 at risk EG0021 affected54 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected107 at risk EG0011 affected106 at risk EG0020 affected54 at risk
Chest discomfort	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected107 at risk EG0010 affected106 at risk EG0020 affected54 at risk
Feeling hot	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected107 at risk EG0011 affected106 at risk EG0020 affected54 at risk
Feeling jittery	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected107 at risk EG0010 affected106 at risk EG0021 affected54 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected107 at risk EG0011 affected106 at risk EG0020 affected54 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected107 at risk EG0010 affected106 at risk EG0021 affected54 at risk
Blood pressure increased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected107 at risk EG0010 affected106 at risk EG0021 affected54 at risk
Cardiac murmur	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected107 at risk EG0010 affected106 at risk EG0020 affected54 at risk
Dizziness	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0009 affected107 at risk EG0019 affected106 at risk EG0022 affected54 at risk
Headache	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0006 affected107 at risk EG0013 affected106 at risk EG00210 affected54 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected107 at risk EG0010 affected106 at risk EG0020 affected54 at risk
Syncope	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected107 at risk EG0011 affected106 at risk EG0020 affected54 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected107 at risk EG0010 affected106 at risk EG0021 affected54 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected107 at risk EG0010 affected106 at risk EG0020 affected54 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected107 at risk EG0010 affected106 at risk EG0020 affected54 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected107 at risk EG0010 affected106 at risk EG0021 affected54 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected107 at risk EG0010 affected106 at risk EG0020 affected54 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected107 at risk EG0010 affected106 at risk EG0020 affected54 at risk
Flushing	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected107 at risk EG0010 affected106 at risk EG0021 affected54 at risk

ID	Term
D010149	Pain, Postoperative

ID	Term
D009288	Naproxen

Ancestor Terms

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

OG000102
OG001101
OG00244

OG000107
OG001106
OG00254

OG000107
OG001106
OG00254

OG000107
OG001106
OG00254

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