| 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. | ITT (Intent to Treat) Population | Posted | | Least Squares Mean | 95% Confidence Interval | Minutes | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. | | OG004 | DPH 50mg | Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally. | | OG005 | 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. |
| | Units | Counts |
|---|
| Participants | - OG00027
- OG00127
- OG00227
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000339.80(259 to 420)
- OG001304.60(224 to 385)
- OG002413.89(333 to 494)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.54 | | | | | | | | | | | | | No | Superiority or Other | | |
|
| 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. | ITT (Intent to Treat) Population | Posted | | Least Squares Mean | 95% Confidence Interval | Minutes | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 |
|
| 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. | ITT (Intent to Treat) Population | Posted | | Least Squares Mean | 95% Confidence Interval | Minutes | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. |
|
| 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? | ITT (Intent to Treat) Population with available data (missing values were not imputed) | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | |
|
| 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? | ITT (Intent to Treat) Population with available data (missing values were not imputed) | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. |
|
| 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? | ITT (Intent to Treat) Population with available data (missing values were not imputed) | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. |
|
| 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? | ITT (Intent to Treat) Population with available data (missing values were not imputed) | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. |
|
| 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? | ITT (Intent to Treat) Population with available data (missing values were not imputed) | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. |
|
| 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? | ITT (Intent to Treat) Population with available data (missing values were not imputed) | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. |
|
| 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? | ITT (Intent to Treat) Population with available data (missing values were not imputed) | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. |
|
| 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? | ITT (Intent to Treat) Population with available data (missing values were not imputed) | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | |
|
| Secondary | Total Sleep Time by Subject Assessment | Subject responded to: Please estimate the number of hours and minutes you think that you slept. | ITT (Intent to Treat) Population | Posted | | Least Squares Mean | 95% Confidence Interval | Minutes | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. |
|
| 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). | ITT (Intent to Treat) Population with available data (missing values were not imputed). | Posted | | Least Squares Mean | 95% Confidence Interval | Scores on a scale | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) |
|
| 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). | ITT (Intent to Treat) Population | Posted | | Mean | Standard Deviation | Scores on a scale | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | |
|
| 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. | ITT (Intent to Treat) Population | Posted | | Least Squares Mean | 95% Confidence Interval | Scores on a scale | | Baseline and up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 |
|
| 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. | ITT (Intent to Treat) Population | Posted | | Mean | Standard Deviation | Scores on a scale | | At 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. |
|
| 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. | ITT (Intent to Treat) Population | Posted | | Least Squares Mean | 95% Confidence Interval | Scores on a scale | | Baseline and up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | |
|
| 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). | ITT (Intent to Treat) Population | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | |
|
| 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. | ITT (Intent to Treat) Population | Posted | | Median | 95% Confidence Interval | Minutes | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | |
|
| 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. | ITT (Intent to Treat) Population | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | |
|
| 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) | ITT (Intent to Treat) Population | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | |
|
| 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. | ITT (Intent to Treat) Population | Posted | | Number | | Participants | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | |
|
| 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. | ITT (Intent to Treat) Population | Posted | | Least Squares Mean | 95% Confidence Interval | Minutes | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) | |
|
| Secondary | Sleep Efficiency Measured by Actigraphy | Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. | ITT (Intent to Treat) Population | Posted | | Least Squares Mean | 95% Confidence Interval | Percentage of sleep time | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 |
|
| 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. | ITT (Intent to Treat) Population | Posted | | Least Squares Mean | 95% Confidence Interval | Movement per minute | | Up to 10 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) |
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| 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). | | Posted | | Least Squares Mean | 95% Confidence Interval | Wake episodes | | Up to 10 hours | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Naproxen Sodium 440 mg (BAYH6689) | Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | | OG002 | 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. | | OG003 | Naproxen Sodium 220 mg (BAYH6689) |
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