Pain, Postoperative
Conditions
Keywords
Naproxen sodium, Diphenhydramine
Brief summary
The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.
Interventions
DRUGNaproxen sodium 440 mg / DPH 50 mg (BAY98-7111)
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
DRUGNaproxen 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
Participants received two Naproxen sodium 220 mg tablets orally, single dose
DRUGDPH 50 mg
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wake Time After Sleep Onset (WASO) Measured by Actigraphy | Up to 10 hours | 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. |
| Sleep Latency Measured by Actigraphy | Up to 10 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of Investigational Product as a Sleep Aid | Up to 10 hours | 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). |
| Karolinska Sleep Diary - Sleep Quality | Up to 10 hours | 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) |
| Karolinska Sleep Diary - Calmness of Sleep | Up to 10 hours | 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) |
| Karolinska Sleep Diary - Easiness to Fall Asleep | Up to 10 hours | 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) |
| Karolinska Sleep Diary - Premature Awakening | Up to 10 hours | Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3) |
| Karolinska Sleep Diary - Ease of Awakening | Up to 10 hours | 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) |
| Karolinska Sleep Diary - Well Rested | Up to 10 hours | Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3) |
| Karolinska Sleep Diary - Sufficient Sleep | Up to 10 hours | 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) |
| Total Sleep Time Measured by Actigraphy | Up to 10 hours | 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. |
| Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night | Up to 10 hours | Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing) |
| Subjective Sleep Questionnaire - Time to Fall Asleep Last Night | Up to 10 hours | Subjects responded to Estimate of how long it took to fall asleep (minutes) |
| 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 | Up to 10 hours | 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) |
| Change From Baseline in Pain Intensity | Baseline and up to 10 hours | Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain |
| Overall Rating of Pain Relief | Up to 10 hours | 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). |
| Time to Rescue Medication | Up to 10 hours | If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded |
| Cumulative Proportion of Subjects Taking Rescue Medication by Hour | Up to 10 hours | If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded |
| Global Assessment of Investigational Product as a Pain Reliever | Up to 10 hours | 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). |
| Subjective Sleep Questionnaire - Quality of Your Sleep Last Night | Up to 10 hours | Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent) |
| Sleep Efficiency Measured by Actigraphy | Up to 10 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| 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 |
| Naproxen Sodium 440 mg (BAYH6689) Participants received two Naproxen sodium 220 mg tablets orally, single dose | 203 |
| DPH 50 mg Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose | 102 |
| Total | 712 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Does not meet exclusion #27 criteria | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Naproxen Sodium 440 mg (BAYH6689) | Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | DPH 50 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 21.0 Years STANDARD_DEVIATION 4.25 | 21.0 Years STANDARD_DEVIATION 4.5 | 21.4 Years STANDARD_DEVIATION 4.87 | 21.5 Years STANDARD_DEVIATION 5.59 | 21.2 Years STANDARD_DEVIATION 4.7 |
| Baseline Categorical Pain Rating Scale Mild pain | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Baseline Categorical Pain Rating Scale Moderate pain | 134 Participants | 140 Participants | 146 Participants | 74 Participants | 494 Participants |
| Baseline Categorical Pain Rating Scale No pain | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Baseline Categorical Pain Rating Scale Severe pain | 70 Participants | 63 Participants | 57 Participants | 28 Participants | 218 Participants |
| Sex: Female, Male Female | 124 Participants | 117 Participants | 108 Participants | 54 Participants | 403 Participants |
| Sex: Female, Male Male | 80 Participants | 86 Participants | 95 Participants | 48 Participants | 309 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 37 / 203 | 37 / 204 | 40 / 203 | 25 / 102 |
| serious Total, serious adverse events | 0 / 203 | 0 / 204 | 0 / 203 | 0 / 102 |
Outcome results
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.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Sleep Latency Measured by Actigraphy | 25.50 Minutes |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Sleep Latency Measured by Actigraphy | 30.25 Minutes |
| Naproxen Sodium 440 mg (BAYH6689) | Sleep Latency Measured by Actigraphy | 25.75 Minutes |
| DPH 50 mg | Sleep Latency Measured by Actigraphy | 41.50 Minutes |
p-value: <0.0001Log Rank
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.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Wake Time After Sleep Onset (WASO) Measured by Actigraphy | 143.7 Minutes |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Wake Time After Sleep Onset (WASO) Measured by Actigraphy | 230.9 Minutes |
| Naproxen Sodium 440 mg (BAYH6689) | Wake Time After Sleep Onset (WASO) Measured by Actigraphy | 214.0 Minutes |
| DPH 50 mg | Wake Time After Sleep Onset (WASO) Measured by Actigraphy | 431.4 Minutes |
p-value: 0.000295% CI: [-106.8, -33.7]ANCOVA
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
Time frame: Baseline and up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Change From Baseline in Pain Intensity | -1.2 Scores on a scale | Standard Deviation 1.01 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Change From Baseline in Pain Intensity | -0.7 Scores on a scale | Standard Deviation 1.05 |
| Naproxen Sodium 440 mg (BAYH6689) | Change From Baseline in Pain Intensity | -0.9 Scores on a scale | Standard Deviation 0.99 |
| DPH 50 mg | Change From Baseline in Pain Intensity | 0.1 Scores on a scale | Standard Deviation 0.82 |
p-value: 0.0064ANCOVA
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
Time frame: Up to 10 hours
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 60 minutes | 0 participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 120 minutes | 18 participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 180 minutes | 23 participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 240 minutes | 25 participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 300 minutes | 29 participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 360 minutes | 34 participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 420 minutes | 36 participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 480 minutes | 39 participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 540 minutes | 42 participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 600 minutes | 43 participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 180 minutes | 50 participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 540 minutes | 87 participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 240 minutes | 57 participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 300 minutes | 65 participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 360 minutes | 69 participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 420 minutes | 78 participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 600 minutes | 89 participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 480 minutes | 83 participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 60 minutes | 1 participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 120 minutes | 36 participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 480 minutes | 63 participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 420 minutes | 62 participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 600 minutes | 68 participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 60 minutes | 0 participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 240 minutes | 47 participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 360 minutes | 55 participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 540 minutes | 67 participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 120 minutes | 27 participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 300 minutes | 50 participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 180 minutes | 41 participants |
| DPH 50 mg | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 300 minutes | 74 participants |
| DPH 50 mg | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 480 minutes | 78 participants |
| DPH 50 mg | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 360 minutes | 76 participants |
| DPH 50 mg | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 600 minutes | 78 participants |
| DPH 50 mg | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 420 minutes | 77 participants |
| DPH 50 mg | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 120 minutes | 53 participants |
| DPH 50 mg | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 180 minutes | 66 participants |
| DPH 50 mg | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 240 minutes | 70 participants |
| DPH 50 mg | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 60 minutes | 0 participants |
| DPH 50 mg | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | ≤ 540 minutes | 78 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).
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Pain Reliever | 1 = Fair | 9 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Pain Reliever | 0 = Poor | 2 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Pain Reliever | 2 = Good | 43 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Pain Reliever | 4 = Excellent | 48 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Pain Reliever | 3 = Very good | 64 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Pain Reliever | 3 = Very good | 48 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Pain Reliever | 4 = Excellent | 25 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Pain Reliever | 0 = Poor | 2 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Pain Reliever | 1 = Fair | 16 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Pain Reliever | 2 = Good | 35 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Investigational Product as a Pain Reliever | 1 = Fair | 15 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Investigational Product as a Pain Reliever | 3 = Very good | 56 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Investigational Product as a Pain Reliever | 4 = Excellent | 34 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Investigational Product as a Pain Reliever | 2 = Good | 36 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Investigational Product as a Pain Reliever | 0 = Poor | 0 Participants |
| DPH 50 mg | Global Assessment of Investigational Product as a Pain Reliever | 3 = Very good | 7 Participants |
| DPH 50 mg | Global Assessment of Investigational Product as a Pain Reliever | 2 = Good | 9 Participants |
| DPH 50 mg | Global Assessment of Investigational Product as a Pain Reliever | 1 = Fair | 5 Participants |
| DPH 50 mg | Global Assessment of Investigational Product as a Pain Reliever | 0 = Poor | 4 Participants |
| DPH 50 mg | Global Assessment of Investigational Product as a Pain Reliever | 4 = Excellent | 0 Participants |
p-value: 0.2734Cochran-Mantel-Haenszel
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).
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Sleep Aid | 3 = Very good | 49 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Sleep Aid | 1 = Fair | 39 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Sleep Aid | 4 = Excellent | 12 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Sleep Aid | 2 = Good | 58 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Sleep Aid | 0 = Poor | 8 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Sleep Aid | 2 = Good | 47 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Sleep Aid | 3 = Very good | 26 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Sleep Aid | 4 = Excellent | 13 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Sleep Aid | 1 = Fair | 29 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Global Assessment of Investigational Product as a Sleep Aid | 0 = Poor | 10 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Investigational Product as a Sleep Aid | 2 = Good | 37 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Investigational Product as a Sleep Aid | 0 = Poor | 29 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Investigational Product as a Sleep Aid | 1 = Fair | 51 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Investigational Product as a Sleep Aid | 3 = Very good | 17 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Investigational Product as a Sleep Aid | 4 = Excellent | 7 Participants |
| DPH 50 mg | Global Assessment of Investigational Product as a Sleep Aid | 3 = Very good | 7 Participants |
| DPH 50 mg | Global Assessment of Investigational Product as a Sleep Aid | 1 = Fair | 9 Participants |
| DPH 50 mg | Global Assessment of Investigational Product as a Sleep Aid | 0 = Poor | 3 Participants |
| DPH 50 mg | Global Assessment of Investigational Product as a Sleep Aid | 2 = Good | 6 Participants |
| DPH 50 mg | Global Assessment of Investigational Product as a Sleep Aid | 4 = Excellent | 0 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
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)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Calmness of Sleep | 4 = Rather calm | 76 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Calmness of Sleep | 2 = Rather restless | 35 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Calmness of Sleep | 5 = Very calm | 32 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Calmness of Sleep | 3 = Neither restless nor calm | 37 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Calmness of Sleep | 1 = Very restless | 8 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Calmness of Sleep | 3 = Neither restless nor calm | 39 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Calmness of Sleep | 4 = Rather calm | 68 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Calmness of Sleep | 5 = Very calm | 26 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Calmness of Sleep | 2 = Rather restless | 29 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Calmness of Sleep | 1 = Very restless | 8 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 3 = Neither restless nor calm | 42 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 1 = Very restless | 7 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 2 = Rather restless | 48 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 4 = Rather calm | 61 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 5 = Very calm | 22 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Calmness of Sleep | 4 = Rather calm | 12 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Calmness of Sleep | 2 = Rather restless | 16 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Calmness of Sleep | 1 = Very restless | 5 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Calmness of Sleep | 3 = Neither restless nor calm | 10 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Calmness of Sleep | 5 = Very calm | 3 Participants |
p-value: 0.0321Cochran-Mantel-Haenszel
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)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Ease of Awakening | 4 = Rather easy | 98 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Ease of Awakening | 2 = Rather difficult | 7 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Ease of Awakening | 5 = Very easy | 55 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Ease of Awakening | 3 = Neither difficult nor easy | 28 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Ease of Awakening | 1 = Very difficult | 0 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Ease of Awakening | 3 = Neither difficult nor easy | 24 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Ease of Awakening | 4 = Rather easy | 94 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Ease of Awakening | 5 = Very easy | 48 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Ease of Awakening | 2 = Rather difficult | 4 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Ease of Awakening | 1 = Very difficult | 0 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 3 = Neither difficult nor easy | 33 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 1 = Very difficult | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 2 = Rather difficult | 2 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 4 = Rather easy | 88 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 5 = Very easy | 56 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Ease of Awakening | 4 = Rather easy | 15 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Ease of Awakening | 2 = Rather difficult | 1 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Ease of Awakening | 1 = Very difficult | 0 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Ease of Awakening | 3 = Neither difficult nor easy | 10 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Ease of Awakening | 5 = Very easy | 20 Participants |
p-value: >0.05Cochran-Mantel-Haenszel
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)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Easiness to Fall Asleep | 4 = Rather easy | 62 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Easiness to Fall Asleep | 2 = Rather difficult | 41 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Easiness to Fall Asleep | 5 = Very easy | 20 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Easiness to Fall Asleep | 3 = Neither difficult nor easy | 57 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Easiness to Fall Asleep | 1 = Very difficult | 8 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Easiness to Fall Asleep | 3 = Neither difficult nor easy | 57 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Easiness to Fall Asleep | 4 = Rather easy | 42 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Easiness to Fall Asleep | 5 = Very easy | 15 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Easiness to Fall Asleep | 2 = Rather difficult | 45 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Easiness to Fall Asleep | 1 = Very difficult | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 3 = Neither difficult nor easy | 55 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 1 = Very difficult | 12 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 2 = Rather difficult | 59 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 4 = Rather easy | 41 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 5 = Very easy | 13 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 4 = Rather easy | 9 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 2 = Rather difficult | 16 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 1 = Very difficult | 8 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 3 = Neither difficult nor easy | 10 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 5 = Very easy | 3 Participants |
p-value: 0.0019Cochran-Mantel-Haenszel
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)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Premature Awakening | 1 = Woke up much too early | 40 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Premature Awakening | 3 = No | 71 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Premature Awakening | 2 = Woke up somewhat too early | 77 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Premature Awakening | 1 = Woke up much too early | 54 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Premature Awakening | 3 = No | 57 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Premature Awakening | 2 = Woke up somewhat too early | 59 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Premature Awakening | 2 = Woke up somewhat too early | 80 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Premature Awakening | 1 = Woke up much too early | 65 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Premature Awakening | 3 = No | 35 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Premature Awakening | 1 = Woke up much too early | 23 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Premature Awakening | 3 = No | 6 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Premature Awakening | 2 = Woke up somewhat too early | 17 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
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)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sleep Quality | 5 = Very good | 34 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sleep Quality | 4 = Rather good | 82 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sleep Quality | 1 = Very poor | 3 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sleep Quality | 2 = Rather poor | 23 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sleep Quality | 3 = Neither poor nor good | 46 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sleep Quality | 1 = Very poor | 5 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sleep Quality | 2 = Rather poor | 24 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sleep Quality | 4 = Rather good | 68 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sleep Quality | 3 = Neither poor nor good | 52 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sleep Quality | 5 = Very good | 21 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 4 = Rather good | 55 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 1 = Very poor | 5 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 5 = Very good | 12 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 2 = Rather poor | 39 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 3 = Neither poor nor good | 69 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Sleep Quality | 2 = Rather poor | 10 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Sleep Quality | 1 = Very poor | 3 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Sleep Quality | 4 = Rather good | 18 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Sleep Quality | 3 = Neither poor nor good | 13 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Sleep Quality | 5 = Very good | 2 Participants |
p-value: 0.0027Cochran-Mantel-Haenszel
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)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sufficient Sleep | 4 = Yes, almost enough | 84 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sufficient Sleep | 2 = No, much too little | 14 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sufficient Sleep | 5 = Yes, definitely enough | 46 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sufficient Sleep | 3 = No, somewhat too little | 37 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sufficient Sleep | 1 = No, definitely too little | 7 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sufficient Sleep | 3 = No, somewhat too little | 40 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sufficient Sleep | 4 = Yes, almost enough | 52 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sufficient Sleep | 5 = Yes, definitely enough | 33 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sufficient Sleep | 2 = No, much too little | 24 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Sufficient Sleep | 1 = No, definitely too little | 21 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 3 = No, somewhat too little | 56 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 1 = No, definitely too little | 18 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 2 = No, much too little | 22 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 4 = Yes, almost enough | 58 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 5 = Yes, definitely enough | 26 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Sufficient Sleep | 4 = Yes, almost enough | 9 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Sufficient Sleep | 2 = No, much too little | 8 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Sufficient Sleep | 1 = No, definitely too little | 10 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Sufficient Sleep | 3 = No, somewhat too little | 14 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Sufficient Sleep | 5 = Yes, definitely enough | 5 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
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)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Well Rested | 1 = Not rested at all | 9 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Well Rested | 3 = Completely rested | 79 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Well Rested | 2 = Somewhat unrested | 100 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Well Rested | 1 = Not rested at all | 21 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Well Rested | 3 = Completely rested | 54 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Karolinska Sleep Diary - Well Rested | 2 = Somewhat unrested | 95 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Well Rested | 2 = Somewhat unrested | 116 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Well Rested | 1 = Not rested at all | 16 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Well Rested | 3 = Completely rested | 48 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Well Rested | 1 = Not rested at all | 8 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Well Rested | 3 = Completely rested | 7 Participants |
| DPH 50 mg | Karolinska Sleep Diary - Well Rested | 2 = Somewhat unrested | 31 Participants |
p-value: 0.0012Cochran-Mantel-Haenszel
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).
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Overall Rating of Pain Relief | 2 = Some relief | 32 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Overall Rating of Pain Relief | 4 = Complete relief | 58 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Overall Rating of Pain Relief | 1 = A little relief | 4 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Overall Rating of Pain Relief | 0 = No relief | 44 Participants |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Overall Rating of Pain Relief | 3 = A lot of relief | 65 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Overall Rating of Pain Relief | 0 = No relief | 89 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Overall Rating of Pain Relief | 1 = A little relief | 4 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Overall Rating of Pain Relief | 4 = Complete relief | 29 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Overall Rating of Pain Relief | 3 = A lot of relief | 53 Participants |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Overall Rating of Pain Relief | 2 = Some relief | 29 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Pain Relief | 3 = A lot of relief | 62 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Pain Relief | 2 = Some relief | 24 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Pain Relief | 0 = No relief | 68 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Pain Relief | 1 = A little relief | 8 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Pain Relief | 4 = Complete relief | 40 Participants |
| DPH 50 mg | Overall Rating of Pain Relief | 4 = Complete relief | 3 Participants |
| DPH 50 mg | Overall Rating of Pain Relief | 1 = A little relief | 1 Participants |
| DPH 50 mg | Overall Rating of Pain Relief | 0 = No relief | 79 Participants |
| DPH 50 mg | Overall Rating of Pain Relief | 2 = Some relief | 11 Participants |
| DPH 50 mg | Overall Rating of Pain Relief | 3 = A lot of relief | 8 Participants |
p-value: 0.0047Cochran-Mantel-Haenszel
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.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Sleep Efficiency Measured by Actigraphy | 71.0 Percent of sleep time during in-bed time |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Sleep Efficiency Measured by Actigraphy | 56.3 Percent of sleep time during in-bed time |
| Naproxen Sodium 440 mg (BAYH6689) | Sleep Efficiency Measured by Actigraphy | 59.3 Percent of sleep time during in-bed time |
| DPH 50 mg | Sleep Efficiency Measured by Actigraphy | 23.6 Percent of sleep time during in-bed time |
p-value: 0.000795% CI: [3.7, 19.7]ANCOVA
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)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 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 | 73.8 Minutes | Standard Deviation 79.06 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 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 | 75.3 Minutes | Standard Deviation 81.55 |
| Naproxen Sodium 440 mg (BAYH6689) | 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 | 103.5 Minutes | Standard Deviation 89.5 |
| DPH 50 mg | 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 | 81.7 Minutes | Standard Deviation 86.72 |
p-value: <0.0001Cochran-Mantel-Haenszel
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)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Subjective Sleep Questionnaire - Quality of Your Sleep Last Night | 6.4 Scores on a scale | Standard Deviation 1.96 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Subjective Sleep Questionnaire - Quality of Your Sleep Last Night | 5.9 Scores on a scale | Standard Deviation 2.13 |
| Naproxen Sodium 440 mg (BAYH6689) | Subjective Sleep Questionnaire - Quality of Your Sleep Last Night | 5.4 Scores on a scale | Standard Deviation 1.99 |
| DPH 50 mg | Subjective Sleep Questionnaire - Quality of Your Sleep Last Night | 4.9 Scores on a scale | Standard Deviation 2.36 |
p-value: <0.0001Cochran-Mantel-Haenszel
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)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night | 6.2 Scores on a scale | Standard Deviation 2.03 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night | 5.8 Scores on a scale | Standard Deviation 2.26 |
| Naproxen Sodium 440 mg (BAYH6689) | Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night | 5.5 Scores on a scale | Standard Deviation 2.14 |
| DPH 50 mg | Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night | 4.4 Scores on a scale | Standard Deviation 2.45 |
p-value: 0.0016Cochran-Mantel-Haenszel
Secondary
Subjective Sleep Questionnaire - Time to Fall Asleep Last Night
Subjects responded to Estimate of how long it took to fall asleep (minutes)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Subjective Sleep Questionnaire - Time to Fall Asleep Last Night | 40.0 Minutes | Standard Deviation 31.52 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Subjective Sleep Questionnaire - Time to Fall Asleep Last Night | 40.7 Minutes | Standard Deviation 29.39 |
| Naproxen Sodium 440 mg (BAYH6689) | Subjective Sleep Questionnaire - Time to Fall Asleep Last Night | 53.4 Minutes | Standard Deviation 67.78 |
| DPH 50 mg | Subjective Sleep Questionnaire - Time to Fall Asleep Last Night | 42.4 Minutes | Standard Deviation 42.02 |
p-value: >0.05Cochran-Mantel-Haenszel
Secondary
Time to Rescue Medication
If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Time to Rescue Medication | NA Minutes |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Time to Rescue Medication | NA Minutes |
| Naproxen Sodium 440 mg (BAYH6689) | Time to Rescue Medication | NA Minutes |
| DPH 50 mg | Time to Rescue Medication | 113.5 Minutes |
p-value: 0.0053Log Rank
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.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | Total Sleep Time Measured by Actigraphy | 426.2 Minutes |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | Total Sleep Time Measured by Actigraphy | 337.7 Minutes |
| Naproxen Sodium 440 mg (BAYH6689) | Total Sleep Time Measured by Actigraphy | 355.8 Minutes |
| DPH 50 mg | Total Sleep Time Measured by Actigraphy | 141.4 Minutes |
p-value: 0.000195% CI: [28.1, 112.7]ANCOVA