Sleep
Conditions
Keywords
Naproxen sodium, Diphenhydramine, Drugs, Investigational
Brief summary
The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination
Interventions
DRUGNaproxen Sodium 440 mg (BAYH6689) / DPH 50mg
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
DRUGNaproxen Sodium 220 mg (BAYH6689) / DPH 50mg
One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg
DRUGNaproxen Sodium 220 mg (BAYH6689)
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
DRUGDPH 50mg
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
DRUGIbuprofen 400 mg / Diphenhydramine citrate 76 mg
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Healthy, ambulatory, male and female volunteers between 16-45 years of age; * Scheduled to undergo surgical removal of 1 to 3 impacted third molars, one of which must be at least a partial bony mandibular impaction; * 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 by 2030 h +/- 15 minutes 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 antiinflammatory drugs (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 negative 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time Measured by Actigraphy | Up to 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. In calculating the total sleep time, subjects who took rescue medication were treated as awake from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Karolinska Sleep Diary - Sufficient Sleep | Up to 10 hours | Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep? |
| Total Sleep Time by Subject Assessment | Up to 10 hours | Subject responded to: Please estimate the number of hours and minutes you think that you slept. |
| Wake After Sleep Onset (WASO) Measured by Actigraphy | Up to 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. WASO was defined as minutes of awake during the period of sleep onset and offset, where sleep onset is the first 20-minute block with 19 minutes of sleep. |
| Sleep Latency Measured by Actigraphy | Up to 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. Sleep latency was defined as minutes to sleep onset since dosing, where sleep onset was the first 20-minute block with 19 minutes of sleep. For subjects who had not achieved sleep onset (e.g., due to taking rescue medication before achieving sleep onset), sleep latency was considered as censored at the time of wakening. |
| Karolinska Sleep Diary - Sleep Quality | Up to 10 hours | Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep? |
| Karolinska Sleep Diary - Calmness of Sleep | Up to 10 hours | Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep? |
| Karolinska Sleep Diary - Easiness to Fall Asleep | Up to 10 hours | Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep? |
| Karolinska Sleep Diary - Premature Awakening | Up to 10 hours | Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening? |
| Karolinska Sleep Diary - Ease of Awakening | Up to 10 hours | Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening? |
| Karolinska Sleep Diary - Well Rested | Up to 10 hours | Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested? |
| Sleep Quality Index | Up to 10 hours | Sleep Quality Index is the mean score of items, 'sleep quality', 'calm sleep', 'ease falling asleep', and 'slept throughout' on the Karolinska Sleep Diary, ranges from 1 (worst possible) to 5 (best possible). |
| Overall Rating of Severity in Categorical Pain Rating Scale Score | Up to 10 hours | Subject responded to question, 'My pain at this time is' by selecting one of the following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). |
| Global Assessment of Study Medication as a Sleep-aid | Up to 10 hours | Subject rating of following question with 0 being poor to 4 being excellent: How would you rate the study medication you received as a sleep aid? |
| Overall Rating of Severity in Visual Analog Scale (VAS) Score | At 10 hours | Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain. |
| Change From Baseline in Visual Analog Scale (VAS) Score | Baseline and up to 10 hours | Subjects completed the VAS scale at baseline (post-dental surgery) and after completion of the sleep period. Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.This measure indicates the change in pain severity rating on the VAS scale from baseline. |
| Overall Rating of Pain Relief | Up to 10 hours | Subjects responded to question, Overall, the relief from my starting pain was by checking one of the following choices: 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 | Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the time to taking rescue medication from the time the subject took study treatment. |
| Cumulative Proportion of Participants Taking Rescue Medication by Hour | Up to 10 hours | Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the proportion of subjects who rescued in the study. |
| Global Assessment of Study Medication as a Pain Reliever | Up to 10 hours | Subject responded to question, 'How would you rating this study medication you received as a pain-reliever?' with the following choices: Poor (0), Fair(1), Good(2), Very Good(3), Excellent(4) |
| Number of Times Participants Took Rescue Medication | Up to 10 hours | Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the number of times rescue medication was taken by a subject. |
| Total Wake Time Measured by Actigraphy | Up to 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. |
| 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. |
| Activity Mean Measured by Actigraphy | Up to 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. Activity mean - average movement per minute. |
| Wake Episode Measured by Actigraphy | Up to 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. Wake Episodes - # of blocks of continuous wake epochs (defined as 2 or more consecutive epochs scored as wake that ends when there is at least one epoch scored as sleep subsequent to the start of the wake epochs). |
| Change From Baseline in Categorical Pain Rating Scale Score | Baseline and up to 10 hours | Subjects responded to question, 'My pain at this time is' with following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Subjects completed this question at baseline (post-dental surgery) and after sleep period. The following measure is the change in pain rating from baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | 27 |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally. | 27 |
| Naproxen Sodium 220 mg (BAYH6689) Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. | 27 |
| DPH 50mg Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally. | 27 |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally. | 27 |
| Naproxen Sodium 440 mg (BAYH6689) Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | 27 |
| Total | 162 |
Baseline characteristics
| Characteristic | Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Naproxen Sodium 220 mg (BAYH6689) | DPH 50mg | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Naproxen Sodium 440 mg (BAYH6689) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 20 years STANDARD_DEVIATION 2.8 | 19 years STANDARD_DEVIATION 2 | 19 years STANDARD_DEVIATION 3 | 19 years STANDARD_DEVIATION 2.8 | 19 years STANDARD_DEVIATION 2.5 | 20 years STANDARD_DEVIATION 2.6 | 19 years STANDARD_DEVIATION 2.6 |
| Baseline Categorical Pain Rating Scale Mild pain | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Baseline Categorical Pain Rating Scale Moderate pain | 14 Participants | 14 Participants | 17 Participants | 15 Participants | 21 Participants | 14 Participants | 95 Participants |
| Baseline Categorical Pain Rating Scale No pain | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Baseline Categorical Pain Rating Scale Severe pain | 13 Participants | 13 Participants | 10 Participants | 12 Participants | 6 Participants | 13 Participants | 67 Participants |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 19 Participants | 16 Participants | 12 Participants | 12 Participants | 84 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 8 Participants | 11 Participants | 15 Participants | 15 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 27 | 2 / 27 | 3 / 27 | 1 / 27 | 5 / 27 | 1 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 | 0 / 27 | 0 / 27 | 0 / 27 | 0 / 27 |
Outcome results
Primary
Total Sleep Time 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. In calculating the total sleep time, subjects who took rescue medication were treated as awake from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Total Sleep Time Measured by Actigraphy | 339.80 Minutes |
| Naproxen Sodium 440 mg (BAYH6689) | Total Sleep Time Measured by Actigraphy | 304.60 Minutes |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Total Sleep Time Measured by Actigraphy | 413.89 Minutes |
| Naproxen Sodium 220 mg (BAYH6689) | Total Sleep Time Measured by Actigraphy | 308.89 Minutes |
| DPH 50mg | Total Sleep Time Measured by Actigraphy | 76.35 Minutes |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Total Sleep Time Measured by Actigraphy | 335.68 Minutes |
p-value: 0.54ANCOVA
Secondary
Activity Mean 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. Activity mean - average movement per minute.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Activity Mean Measured by Actigraphy | 42.09 Movement per minute |
| Naproxen Sodium 440 mg (BAYH6689) | Activity Mean Measured by Actigraphy | 48.48 Movement per minute |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Activity Mean Measured by Actigraphy | 26.73 Movement per minute |
| Naproxen Sodium 220 mg (BAYH6689) | Activity Mean Measured by Actigraphy | 52.36 Movement per minute |
| DPH 50mg | Activity Mean Measured by Actigraphy | 72.43 Movement per minute |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Activity Mean Measured by Actigraphy | 41.14 Movement per minute |
p-value: 0.59ANCOVA
Secondary
Change From Baseline in Categorical Pain Rating Scale Score
Subjects responded to question, 'My pain at this time is' with following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Subjects completed this question at baseline (post-dental surgery) and after sleep period. The following measure is the change in pain rating from baseline.
Time frame: Baseline and up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Change From Baseline in Categorical Pain Rating Scale Score | -1.2 Scores on a scale |
| Naproxen Sodium 440 mg (BAYH6689) | Change From Baseline in Categorical Pain Rating Scale Score | -1.0 Scores on a scale |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Change From Baseline in Categorical Pain Rating Scale Score | -1.2 Scores on a scale |
| Naproxen Sodium 220 mg (BAYH6689) | Change From Baseline in Categorical Pain Rating Scale Score | -0.7 Scores on a scale |
| DPH 50mg | Change From Baseline in Categorical Pain Rating Scale Score | 0.3 Scores on a scale |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Change From Baseline in Categorical Pain Rating Scale Score | -0.9 Scores on a scale |
p-value: 0.42ANCOVA
Secondary
Change From Baseline in Visual Analog Scale (VAS) Score
Subjects completed the VAS scale at baseline (post-dental surgery) and after completion of the sleep period. Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.This measure indicates the change in pain severity rating on the VAS scale from baseline.
Time frame: Baseline and up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Change From Baseline in Visual Analog Scale (VAS) Score | -44.04 Scores on a scale |
| Naproxen Sodium 440 mg (BAYH6689) | Change From Baseline in Visual Analog Scale (VAS) Score | -36.65 Scores on a scale |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Change From Baseline in Visual Analog Scale (VAS) Score | -47.26 Scores on a scale |
| Naproxen Sodium 220 mg (BAYH6689) | Change From Baseline in Visual Analog Scale (VAS) Score | -25.89 Scores on a scale |
| DPH 50mg | Change From Baseline in Visual Analog Scale (VAS) Score | 6.00 Scores on a scale |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Change From Baseline in Visual Analog Scale (VAS) Score | -35.89 Scores on a scale |
p-value: 0.35ANCOVA
Secondary
Cumulative Proportion of Participants Taking Rescue Medication by Hour
Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the proportion of subjects who rescued in the study.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 2 hours | 6 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 8 hours | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 7 hours | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 10 hours | 12 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 3 hours | 8 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 6 hours | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 5 hours | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 9 hours | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 1 hour | 2 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 4 hours | 10 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 6 hours | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 3 hours | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 1 hour | 3 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 9 hours | 12 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 10 hours | 12 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 7 hours | 12 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 8 hours | 12 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 2 hours | 9 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 4 hours | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 5 hours | 11 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 2 hours | 5 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 7 hours | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 1 hour | 0 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 6 hours | 6 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 5 hours | 5 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 10 hours | 8 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 4 hours | 5 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 3 hours | 5 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 8 hours | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 9 hours | 8 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 4 hours | 10 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 10 hours | 13 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 8 hours | 13 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 1 hour | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 7 hours | 13 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 9 hours | 13 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 2 hours | 9 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 5 hours | 11 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 3 hours | 9 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 6 hours | 12 Participants |
| DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 2 hours | 17 Participants |
| DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 4 hours | 21 Participants |
| DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 10 hours | 25 Participants |
| DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 5 hours | 24 Participants |
| DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 1 hour | 4 Participants |
| DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 3 hours | 20 Participants |
| DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 9 hours | 25 Participants |
| DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 7 hours | 25 Participants |
| DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 8 hours | 25 Participants |
| DPH 50mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 6 hours | 25 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 6 hours | 9 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 7 hours | 10 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 8 hours | 10 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 1 hour | 0 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 5 hours | 7 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 2 hours | 7 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 3 hours | 7 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 4 hours | 7 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 10 hours | 11 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Cumulative Proportion of Participants Taking Rescue Medication by Hour | 9 hours | 11 Participants |
Secondary
Global Assessment of Study Medication as a Pain Reliever
Subject responded to question, 'How would you rating this study medication you received as a pain-reliever?' with the following choices: Poor (0), Fair(1), Good(2), Very Good(3), Excellent(4)
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Poor | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Excellent | 2 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Very good | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Fair | 6 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Good | 7 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Study Medication as a Pain Reliever | Excellent | 5 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Study Medication as a Pain Reliever | Fair | 7 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Study Medication as a Pain Reliever | Good | 7 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Study Medication as a Pain Reliever | Very good | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Study Medication as a Pain Reliever | Poor | 4 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Fair | 5 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Poor | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Excellent | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Good | 4 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Very good | 9 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Global Assessment of Study Medication as a Pain Reliever | Excellent | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Global Assessment of Study Medication as a Pain Reliever | Very good | 9 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Global Assessment of Study Medication as a Pain Reliever | Good | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Global Assessment of Study Medication as a Pain Reliever | Poor | 6 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Global Assessment of Study Medication as a Pain Reliever | Fair | 4 Participants |
| DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Very good | 0 Participants |
| DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Fair | 7 Participants |
| DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Excellent | 0 Participants |
| DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Good | 5 Participants |
| DPH 50mg | Global Assessment of Study Medication as a Pain Reliever | Poor | 15 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Global Assessment of Study Medication as a Pain Reliever | Good | 4 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Global Assessment of Study Medication as a Pain Reliever | Excellent | 2 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Global Assessment of Study Medication as a Pain Reliever | Fair | 5 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Global Assessment of Study Medication as a Pain Reliever | Poor | 5 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Global Assessment of Study Medication as a Pain Reliever | Very good | 11 Participants |
p-value: 0.35Cochran-Mantel-Haenszel
Secondary
Global Assessment of Study Medication as a Sleep-aid
Subject rating of following question with 0 being poor to 4 being excellent: How would you rate the study medication you received as a sleep aid?
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 (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Very good | 5 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Fair | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Poor | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Excellent | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Good | 8 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Study Medication as a Sleep-aid | Fair | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Study Medication as a Sleep-aid | Very good | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Study Medication as a Sleep-aid | Poor | 6 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Study Medication as a Sleep-aid | Excellent | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Global Assessment of Study Medication as a Sleep-aid | Good | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Fair | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Very good | 8 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Excellent | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Good | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Poor | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Global Assessment of Study Medication as a Sleep-aid | Good | 6 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Global Assessment of Study Medication as a Sleep-aid | Poor | 4 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Global Assessment of Study Medication as a Sleep-aid | Fair | 6 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Global Assessment of Study Medication as a Sleep-aid | Very good | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Global Assessment of Study Medication as a Sleep-aid | Excellent | 1 Participants |
| DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Very good | 2 Participants |
| DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Poor | 6 Participants |
| DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Excellent | 0 Participants |
| DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Fair | 7 Participants |
| DPH 50mg | Global Assessment of Study Medication as a Sleep-aid | Good | 3 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Global Assessment of Study Medication as a Sleep-aid | Poor | 0 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Global Assessment of Study Medication as a Sleep-aid | Very good | 7 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Global Assessment of Study Medication as a Sleep-aid | Fair | 6 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Global Assessment of Study Medication as a Sleep-aid | Excellent | 0 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Global Assessment of Study Medication as a Sleep-aid | Good | 9 Participants |
p-value: 0.001Cochran-Mantel-Haenszel
Secondary
Karolinska Sleep Diary - Calmness of Sleep
Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep?
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 (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 2 = Rather restless | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 5 = Very calm | 0 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 4 = Rather calm | 16 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 1 = Very restless | 0 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 3 = Neither restless nor calm | 5 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 1 = Very restless | 2 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 3 = Neither restless nor calm | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 5 = Very calm | 3 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 4 = Rather calm | 6 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 2 = Rather restless | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 4 = Rather calm | 12 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 2 = Rather restless | 6 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 3 = Neither restless nor calm | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 1 = Very restless | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 5 = Very calm | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 2 = Rather restless | 5 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 5 = Very calm | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 1 = Very restless | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 3 = Neither restless nor calm | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Calmness of Sleep | 4 = Rather calm | 6 Participants |
| DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 3 = Neither restless nor calm | 3 Participants |
| DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 1 = Very restless | 1 Participants |
| DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 5 = Very calm | 1 Participants |
| DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 4 = Rather calm | 6 Participants |
| DPH 50mg | Karolinska Sleep Diary - Calmness of Sleep | 2 = Rather restless | 7 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Calmness of Sleep | 4 = Rather calm | 8 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Calmness of Sleep | 3 = Neither restless nor calm | 5 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Calmness of Sleep | 2 = Rather restless | 7 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Calmness of Sleep | 1 = Very restless | 0 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Calmness of Sleep | 5 = Very calm | 2 Participants |
p-value: 0.019ANCOVA
Secondary
Karolinska Sleep Diary - Ease of Awakening
Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening?
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 (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 1 = Very difficult | 0 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 5 = Very easy | 5 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 2 = Rather difficult | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 4 = Rather easy | 15 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 3 = Neither difficult nor easy | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 3 = Neither difficult nor easy | 7 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 4 = Rather easy | 8 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 5 = Very easy | 6 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 | 0 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 4 = Rather easy | 8 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 1 = Very difficult | 0 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 5 = Very easy | 8 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 3 = Neither difficult nor easy | 5 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 2 = Rather difficult | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 4 = Rather easy | 15 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 5 = Very easy | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 1 = Very difficult | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 3 = Neither difficult nor easy | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Ease of Awakening | 2 = Rather difficult | 1 Participants |
| DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 1 = Very difficult | 0 Participants |
| DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 5 = Very easy | 5 Participants |
| DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 2 = Rather difficult | 1 Participants |
| DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 3 = Neither difficult nor easy | 3 Participants |
| DPH 50mg | Karolinska Sleep Diary - Ease of Awakening | 4 = Rather easy | 9 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Ease of Awakening | 1 = Very difficult | 0 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Ease of Awakening | 4 = Rather easy | 14 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Ease of Awakening | 3 = Neither difficult nor easy | 4 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Ease of Awakening | 5 = Very easy | 4 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Ease of Awakening | 2 = Rather difficult | 0 Participants |
p-value: 0.76Cochran-Mantel-Haenszel
Secondary
Karolinska Sleep Diary - Easiness to Fall Asleep
Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep?
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 (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 1 = Very difficult | 0 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 3 = Neither difficult nor easy | 10 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 2 = Rather difficult | 3 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 5 = Very easy | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 4 = Rather easy | 8 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 5 = Very easy | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 3 = Neither difficult nor easy | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 2 = Rather difficult | 3 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 1 = Very difficult | 5 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 4 = Rather easy | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 4 = Rather easy | 8 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 3 = Neither difficult nor easy | 11 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 5 = Very easy | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 1 = Very difficult | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 2 = Rather difficult | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 2 = Rather difficult | 5 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 1 = Very difficult | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 5 = Very easy | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 3 = Neither difficult nor easy | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Easiness to Fall Asleep | 4 = Rather easy | 7 Participants |
| DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 3 = Neither difficult nor easy | 7 Participants |
| DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 1 = Very difficult | 1 Participants |
| DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 4 = Rather easy | 4 Participants |
| DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 5 = Very easy | 0 Participants |
| DPH 50mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 2 = Rather difficult | 6 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 1 = Very difficult | 0 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 3 = Neither difficult nor easy | 7 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 5 = Very easy | 1 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 4 = Rather easy | 9 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Easiness to Fall Asleep | 2 = Rather difficult | 5 Participants |
p-value: 0.018ANCOVA
Secondary
Karolinska Sleep Diary - Premature Awakening
Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening?
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 (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Premature Awakening | 2 = Woke up somewhat too early | 8 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Premature Awakening | 1 = Woke up much too early | 5 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Premature Awakening | 3 = No | 9 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Premature Awakening | 2 = Woke up somewhat too early | 10 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Premature Awakening | 1 = Woke up much too early | 6 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Premature Awakening | 3 = No | 6 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Premature Awakening | 2 = Woke up somewhat too early | 12 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Premature Awakening | 1 = Woke up much too early | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Premature Awakening | 3 = No | 9 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Premature Awakening | 2 = Woke up somewhat too early | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Premature Awakening | 1 = Woke up much too early | 6 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Premature Awakening | 3 = No | 7 Participants |
| DPH 50mg | Karolinska Sleep Diary - Premature Awakening | 2 = Woke up somewhat too early | 6 Participants |
| DPH 50mg | Karolinska Sleep Diary - Premature Awakening | 1 = Woke up much too early | 8 Participants |
| DPH 50mg | Karolinska Sleep Diary - Premature Awakening | 3 = No | 4 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Premature Awakening | 1 = Woke up much too early | 5 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Premature Awakening | 3 = No | 4 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Premature Awakening | 2 = Woke up somewhat too early | 13 Participants |
p-value: 0.03Cochran-Mantel-Haenszel
Secondary
Karolinska Sleep Diary - Sleep Quality
Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep?
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 (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 5 = Very good | 2 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 4 = Rather good | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 3 = Neither poor nor good | 6 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 2 = Rather poor | 2 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 1 = Very poor | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 2 = Rather poor | 0 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 4 = Rather good | 5 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 1 = Very poor | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 3 = Neither poor nor good | 11 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 5 = Very good | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 1 = Very poor | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 2 = Rather poor | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 3 = Neither poor nor good | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 4 = Rather good | 14 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 5 = Very good | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 2 = Rather poor | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 1 = Very poor | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 3 = Neither poor nor good | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 5 = Very good | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Sleep Quality | 4 = Rather good | 9 Participants |
| DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 4 = Rather good | 9 Participants |
| DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 5 = Very good | 0 Participants |
| DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 2 = Rather poor | 5 Participants |
| DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 3 = Neither poor nor good | 3 Participants |
| DPH 50mg | Karolinska Sleep Diary - Sleep Quality | 1 = Very poor | 1 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Sleep Quality | 3 = Neither poor nor good | 10 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Sleep Quality | 5 = Very good | 2 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Sleep Quality | 2 = Rather poor | 1 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Sleep Quality | 1 = Very poor | 0 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Sleep Quality | 4 = Rather good | 9 Participants |
p-value: 0.05ANCOVA
Secondary
Karolinska Sleep Diary - Sufficient Sleep
Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep?
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 (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 2 = No, much too little | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 1 = No, definitely too little | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 3 = No, somewhat too little | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 5 = Yes, definitely enough | 3 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 4 = Yes, almost enough | 10 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 4 = Yes, almost enough | 8 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 3 = No, somewhat too little | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 1 = No, definitely too little | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 5 = Yes, definitely enough | 3 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 2 = No, much too little | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 5 = Yes, definitely enough | 4 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 2 = No, much too little | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 3 = No, somewhat too little | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 1 = No, definitely too little | 0 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 4 = Yes, almost enough | 14 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 4 = Yes, almost enough | 10 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 1 = No, definitely too little | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 3 = No, somewhat too little | 4 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 2 = No, much too little | 1 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Sufficient Sleep | 5 = Yes, definitely enough | 4 Participants |
| DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 2 = No, much too little | 4 Participants |
| DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 1 = No, definitely too little | 2 Participants |
| DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 3 = No, somewhat too little | 8 Participants |
| DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 4 = Yes, almost enough | 4 Participants |
| DPH 50mg | Karolinska Sleep Diary - Sufficient Sleep | 5 = Yes, definitely enough | 0 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Sufficient Sleep | 1 = No, definitely too little | 1 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Sufficient Sleep | 4 = Yes, almost enough | 12 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Sufficient Sleep | 2 = No, much too little | 1 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Sufficient Sleep | 5 = Yes, definitely enough | 2 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Sufficient Sleep | 3 = No, somewhat too little | 6 Participants |
p-value: 0.04Cochran-Mantel-Haenszel
Secondary
Karolinska Sleep Diary - Well Rested
Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested?
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 (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Well Rested | 3 = Completely rested | 8 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Well Rested | 1 = Not rested at all | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Well Rested | 2 = Somewhat unrested | 13 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Well Rested | 2 = Somewhat unrested | 14 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Well Rested | 1 = Not rested at all | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Karolinska Sleep Diary - Well Rested | 3 = Completely rested | 4 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Well Rested | 3 = Completely rested | 9 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Well Rested | 2 = Somewhat unrested | 14 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Karolinska Sleep Diary - Well Rested | 1 = Not rested at all | 0 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Well Rested | 1 = Not rested at all | 0 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Well Rested | 2 = Somewhat unrested | 12 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Karolinska Sleep Diary - Well Rested | 3 = Completely rested | 8 Participants |
| DPH 50mg | Karolinska Sleep Diary - Well Rested | 3 = Completely rested | 1 Participants |
| DPH 50mg | Karolinska Sleep Diary - Well Rested | 1 = Not rested at all | 3 Participants |
| DPH 50mg | Karolinska Sleep Diary - Well Rested | 2 = Somewhat unrested | 14 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Well Rested | 2 = Somewhat unrested | 17 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Well Rested | 1 = Not rested at all | 1 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Karolinska Sleep Diary - Well Rested | 3 = Completely rested | 4 Participants |
p-value: 0.015ANCOVA
Secondary
Number of Times Participants Took Rescue Medication
Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the number of times rescue medication was taken by a subject.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Number of Times Participants Took Rescue Medication | 1 | 12 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Number of Times Participants Took Rescue Medication | 3 | 0 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Number of Times Participants Took Rescue Medication | 2 | 0 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Number of Times Participants Took Rescue Medication | 0 | 15 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Number of Times Participants Took Rescue Medication | 3 | 0 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Number of Times Participants Took Rescue Medication | 2 | 0 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Number of Times Participants Took Rescue Medication | 0 | 15 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Number of Times Participants Took Rescue Medication | 1 | 12 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Number of Times Participants Took Rescue Medication | 0 | 19 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Number of Times Participants Took Rescue Medication | 2 | 0 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Number of Times Participants Took Rescue Medication | 1 | 8 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Number of Times Participants Took Rescue Medication | 3 | 0 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Number of Times Participants Took Rescue Medication | 1 | 13 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Number of Times Participants Took Rescue Medication | 0 | 14 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Number of Times Participants Took Rescue Medication | 2 | 0 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Number of Times Participants Took Rescue Medication | 3 | 0 Participants |
| DPH 50mg | Number of Times Participants Took Rescue Medication | 3 | 0 Participants |
| DPH 50mg | Number of Times Participants Took Rescue Medication | 0 | 2 Participants |
| DPH 50mg | Number of Times Participants Took Rescue Medication | 1 | 22 Participants |
| DPH 50mg | Number of Times Participants Took Rescue Medication | 2 | 3 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Number of Times Participants Took Rescue Medication | 1 | 11 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Number of Times Participants Took Rescue Medication | 2 | 0 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Number of Times Participants Took Rescue Medication | 0 | 16 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Number of Times Participants Took Rescue Medication | 3 | 0 Participants |
Secondary
Overall Rating of Pain Relief
Subjects responded to question, Overall, the relief from my starting pain was by checking one of the following choices: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Overall Rating of Pain Relief | A lot relief | 12 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Overall Rating of Pain Relief | No relief | 1 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Overall Rating of Pain Relief | Some relief | 8 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Overall Rating of Pain Relief | A little relief | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Overall Rating of Pain Relief | Complete relief | 2 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Pain Relief | Complete relief | 3 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Pain Relief | No relief | 3 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Pain Relief | A little relief | 4 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Pain Relief | A lot relief | 10 Participants |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Pain Relief | Some relief | 7 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Overall Rating of Pain Relief | No relief | 2 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Overall Rating of Pain Relief | A lot relief | 13 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Overall Rating of Pain Relief | Complete relief | 4 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Overall Rating of Pain Relief | A little relief | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Overall Rating of Pain Relief | Some relief | 5 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Overall Rating of Pain Relief | No relief | 6 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Overall Rating of Pain Relief | A little relief | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Overall Rating of Pain Relief | Complete relief | 3 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Overall Rating of Pain Relief | A lot relief | 11 Participants |
| Naproxen Sodium 220 mg (BAYH6689) | Overall Rating of Pain Relief | Some relief | 4 Participants |
| DPH 50mg | Overall Rating of Pain Relief | Complete relief | 0 Participants |
| DPH 50mg | Overall Rating of Pain Relief | No relief | 11 Participants |
| DPH 50mg | Overall Rating of Pain Relief | A lot relief | 2 Participants |
| DPH 50mg | Overall Rating of Pain Relief | A little relief | 9 Participants |
| DPH 50mg | Overall Rating of Pain Relief | Some relief | 5 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Overall Rating of Pain Relief | Some relief | 5 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Overall Rating of Pain Relief | Complete relief | 3 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Overall Rating of Pain Relief | A lot relief | 13 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Overall Rating of Pain Relief | No relief | 4 Participants |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Overall Rating of Pain Relief | A little relief | 2 Participants |
p-value: 0.72ANCOVA
Secondary
Overall Rating of Severity in Categorical Pain Rating Scale Score
Subject responded to question, 'My pain at this time is' by selecting one of the following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3).
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Overall Rating of Severity in Categorical Pain Rating Scale Score | Post-Baseline | 1.26 Scores on a scale | Standard Deviation 1.02 |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Overall Rating of Severity in Categorical Pain Rating Scale Score | Baseline | 2.44 Scores on a scale | Standard Deviation 0.51 |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Severity in Categorical Pain Rating Scale Score | Post-Baseline | 1.48 Scores on a scale | Standard Deviation 1.05 |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Severity in Categorical Pain Rating Scale Score | Baseline | 2.48 Scores on a scale | Standard Deviation 0.51 |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Overall Rating of Severity in Categorical Pain Rating Scale Score | Post-Baseline | 1.26 Scores on a scale | Standard Deviation 0.94 |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Overall Rating of Severity in Categorical Pain Rating Scale Score | Baseline | 2.48 Scores on a scale | Standard Deviation 0.51 |
| Naproxen Sodium 220 mg (BAYH6689) | Overall Rating of Severity in Categorical Pain Rating Scale Score | Post-Baseline | 1.78 Scores on a scale | Standard Deviation 0.97 |
| Naproxen Sodium 220 mg (BAYH6689) | Overall Rating of Severity in Categorical Pain Rating Scale Score | Baseline | 2.48 Scores on a scale | Standard Deviation 0.51 |
| DPH 50mg | Overall Rating of Severity in Categorical Pain Rating Scale Score | Baseline | 2.37 Scores on a scale | Standard Deviation 0.49 |
| DPH 50mg | Overall Rating of Severity in Categorical Pain Rating Scale Score | Post-Baseline | 2.67 Scores on a scale | Standard Deviation 0.62 |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Overall Rating of Severity in Categorical Pain Rating Scale Score | Baseline | 2.22 Scores on a scale | Standard Deviation 0.42 |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Overall Rating of Severity in Categorical Pain Rating Scale Score | Post-Baseline | 1.41 Scores on a scale | Standard Deviation 1.01 |
Secondary
Overall Rating of Severity in Visual Analog Scale (VAS) Score
Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.
Time frame: At 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Baseline | 76.11 Scores on a scale | Standard Deviation 11.6 |
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Post-Baseline | 32.11 Scores on a scale | Standard Deviation 31.1 |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Baseline | 77.26 Scores on a scale | Standard Deviation 13.1 |
| Naproxen Sodium 440 mg (BAYH6689) | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Post-Baseline | 40.30 Scores on a scale | Standard Deviation 33 |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Baseline | 78.19 Scores on a scale | Standard Deviation 13.4 |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Post-Baseline | 30.33 Scores on a scale | Standard Deviation 28.6 |
| Naproxen Sodium 220 mg (BAYH6689) | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Baseline | 73.70 Scores on a scale | Standard Deviation 12.3 |
| Naproxen Sodium 220 mg (BAYH6689) | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Post-Baseline | 48.59 Scores on a scale | Standard Deviation 33.4 |
| DPH 50mg | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Baseline | 79.15 Scores on a scale | Standard Deviation 9.76 |
| DPH 50mg | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Post-Baseline | 84.26 Scores on a scale | Standard Deviation 19.9 |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Post-Baseline | 38.19 Scores on a scale | Standard Deviation 32.9 |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Overall Rating of Severity in Visual Analog Scale (VAS) Score | Baseline | 73.11 Scores on a scale | Standard Deviation 10.5 |
p-value: 0.35ANCOVA
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 (BAYH6689) / DPH 50mg | Sleep Efficiency Measured by Actigraphy | 57.24 Percentage of sleep time |
| Naproxen Sodium 440 mg (BAYH6689) | Sleep Efficiency Measured by Actigraphy | 51.49 Percentage of sleep time |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Sleep Efficiency Measured by Actigraphy | 68.87 Percentage of sleep time |
| Naproxen Sodium 220 mg (BAYH6689) | Sleep Efficiency Measured by Actigraphy | 52.09 Percentage of sleep time |
| DPH 50mg | Sleep Efficiency Measured by Actigraphy | 12.85 Percentage of sleep time |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Sleep Efficiency Measured by Actigraphy | 56.70 Percentage of sleep time |
p-value: 0.55ANCOVA
Secondary
Sleep Latency 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 was defined as minutes to sleep onset since dosing, where sleep onset was the first 20-minute block with 19 minutes of sleep. For subjects who had not achieved sleep onset (e.g., due to taking rescue medication before achieving sleep onset), sleep latency was considered as censored at the time of wakening.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Sleep Latency Measured by Actigraphy | 29.17 Minutes |
| Naproxen Sodium 440 mg (BAYH6689) | Sleep Latency Measured by Actigraphy | 32.81 Minutes |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Sleep Latency Measured by Actigraphy | 46.77 Minutes |
| Naproxen Sodium 220 mg (BAYH6689) | Sleep Latency Measured by Actigraphy | 31.58 Minutes |
| DPH 50mg | Sleep Latency Measured by Actigraphy | 41.05 Minutes |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Sleep Latency Measured by Actigraphy | 36.38 Minutes |
p-value: 0.45Log Rank
Secondary
Sleep Quality Index
Sleep Quality Index is the mean score of items, 'sleep quality', 'calm sleep', 'ease falling asleep', and 'slept throughout' on the Karolinska Sleep Diary, ranges from 1 (worst possible) to 5 (best possible).
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population with available data (missing values were not imputed).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Sleep Quality Index | 3.49 Scores on a scale |
| Naproxen Sodium 440 mg (BAYH6689) | Sleep Quality Index | 2.89 Scores on a scale |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Sleep Quality Index | 3.40 Scores on a scale |
| Naproxen Sodium 220 mg (BAYH6689) | Sleep Quality Index | 3.12 Scores on a scale |
| DPH 50mg | Sleep Quality Index | 2.96 Scores on a scale |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Sleep Quality Index | 3.37 Scores on a scale |
p-value: 0.05Cochran-Mantel-Haenszel
Secondary
Time to Rescue Medication
Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the time to taking rescue medication from the time the subject took study treatment.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Time to Rescue Medication | NA Minutes |
| Naproxen Sodium 440 mg (BAYH6689) | Time to Rescue Medication | NA Minutes |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Time to Rescue Medication | NA Minutes |
| Naproxen Sodium 220 mg (BAYH6689) | Time to Rescue Medication | NA Minutes |
| DPH 50mg | Time to Rescue Medication | NA Minutes |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Time to Rescue Medication | NA Minutes |
p-value: 0.001Log Rank
Secondary
Total Sleep Time by Subject Assessment
Subject responded to: Please estimate the number of hours and minutes you think that you slept.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Total Sleep Time by Subject Assessment | 306.32 Minutes |
| Naproxen Sodium 440 mg (BAYH6689) | Total Sleep Time by Subject Assessment | 309.97 Minutes |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Total Sleep Time by Subject Assessment | 339.08 Minutes |
| Naproxen Sodium 220 mg (BAYH6689) | Total Sleep Time by Subject Assessment | 309.23 Minutes |
| DPH 50mg | Total Sleep Time by Subject Assessment | 160.49 Minutes |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Total Sleep Time by Subject Assessment | 299.58 Minutes |
p-value: 0.95ANCOVA
Secondary
Total Wake Time 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 (BAYH6689) / DPH 50mg | Total Wake Time Measured by Actigraphy | 253.72 Minutes |
| Naproxen Sodium 440 mg (BAYH6689) | Total Wake Time Measured by Actigraphy | 290.03 Minutes |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Total Wake Time Measured by Actigraphy | 180.21 Minutes |
| Naproxen Sodium 220 mg (BAYH6689) | Total Wake Time Measured by Actigraphy | 285.62 Minutes |
| DPH 50mg | Total Wake Time Measured by Actigraphy | 518.58 Minutes |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Total Wake Time Measured by Actigraphy | 255.20 Minutes |
p-value: 0.53ANCOVA
Secondary
Wake After Sleep Onset (WASO) 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. WASO was defined as minutes of awake during the period of sleep onset and offset, where sleep onset is the first 20-minute block with 19 minutes of sleep.
Time frame: Up to 10 hours
Population: ITT (Intent to Treat) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Wake After Sleep Onset (WASO) Measured by Actigraphy | 139.96 Minutes |
| Naproxen Sodium 440 mg (BAYH6689) | Wake After Sleep Onset (WASO) Measured by Actigraphy | 190.91 Minutes |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Wake After Sleep Onset (WASO) Measured by Actigraphy | 75.66 Minutes |
| Naproxen Sodium 220 mg (BAYH6689) | Wake After Sleep Onset (WASO) Measured by Actigraphy | 145.67 Minutes |
| DPH 50mg | Wake After Sleep Onset (WASO) Measured by Actigraphy | 428.34 Minutes |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Wake After Sleep Onset (WASO) Measured by Actigraphy | 129.02 Minutes |
p-value: 0.31ANCOVA
Secondary
Wake Episode 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. Wake Episodes - # of blocks of continuous wake epochs (defined as 2 or more consecutive epochs scored as wake that ends when there is at least one epoch scored as sleep subsequent to the start of the wake epochs).
Time frame: Up to 10 hours
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Wake Episode Measured by Actigraphy | 8.38 Wake episodes |
| Naproxen Sodium 440 mg (BAYH6689) | Wake Episode Measured by Actigraphy | 10.86 Wake episodes |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Wake Episode Measured by Actigraphy | 13.26 Wake episodes |
| Naproxen Sodium 220 mg (BAYH6689) | Wake Episode Measured by Actigraphy | 9.89 Wake episodes |
| DPH 50mg | Wake Episode Measured by Actigraphy | 5.84 Wake episodes |
| Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg | Wake Episode Measured by Actigraphy | 11.98 Wake episodes |
p-value: 0.25ANCOVA