Trial Outcomes & Findings for Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine (NCT NCT01118273)
NCT ID: NCT01118273
Last Updated: 2015-06-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
162 participants
Primary outcome timeframe
Up to 10 hours
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
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.
|
Naproxen Sodium 440 mg (BAYH6689)
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
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.
|
Naproxen Sodium 220 mg (BAYH6689)
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
27
|
27
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
27
|
27
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
Baseline characteristics by cohort
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
19 years
STANDARD_DEVIATION 2.8 • n=93 Participants
|
20 years
STANDARD_DEVIATION 2.8 • n=4 Participants
|
19 years
STANDARD_DEVIATION 2.0 • n=27 Participants
|
19 years
STANDARD_DEVIATION 3.0 • n=483 Participants
|
19 years
STANDARD_DEVIATION 2.5 • n=36 Participants
|
20 years
STANDARD_DEVIATION 2.6 • n=10 Participants
|
19 years
STANDARD_DEVIATION 2.6 • n=115 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
84 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
15 Participants
n=10 Participants
|
78 Participants
n=115 Participants
|
|
Baseline Categorical Pain Rating Scale
No pain
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Baseline Categorical Pain Rating Scale
Mild pain
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Baseline Categorical Pain Rating Scale
Moderate pain
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
95 Participants
n=115 Participants
|
|
Baseline Categorical Pain Rating Scale
Severe pain
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
13 Participants
n=10 Participants
|
67 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Total Sleep Time Measured by Actigraphy
|
339.80 Minutes
Interval 259.0 to 420.0
|
304.60 Minutes
Interval 224.0 to 385.0
|
413.89 Minutes
Interval 333.0 to 494.0
|
308.89 Minutes
Interval 228.0 to 389.0
|
76.35 Minutes
Interval -4.0 to 157.0
|
335.68 Minutes
Interval 254.0 to 417.0
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Wake After Sleep Onset (WASO) Measured by Actigraphy
|
139.96 Minutes
Interval 70.0 to 210.0
|
190.91 Minutes
Interval 121.0 to 261.0
|
75.66 Minutes
Interval 7.0 to 144.0
|
145.67 Minutes
Interval 72.0 to 219.0
|
428.34 Minutes
Interval 351.0 to 506.0
|
129.02 Minutes
Interval 59.0 to 199.0
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Sleep Latency Measured by Actigraphy
|
29.17 Minutes
Interval 9.0 to 50.0
|
32.81 Minutes
Interval 12.0 to 53.0
|
46.77 Minutes
Interval 27.0 to 67.0
|
31.58 Minutes
Interval 10.0 to 53.0
|
41.05 Minutes
Interval 18.0 to 64.0
|
36.38 Minutes
Interval 16.0 to 57.0
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
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?
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=23 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=20 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=18 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=22 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Global Assessment of Study Medication as a Sleep-aid
Poor
|
1 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
|
Global Assessment of Study Medication as a Sleep-aid
Fair
|
4 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Global Assessment of Study Medication as a Sleep-aid
Good
|
8 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
9 Participants
|
|
Global Assessment of Study Medication as a Sleep-aid
Very good
|
5 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
|
Global Assessment of Study Medication as a Sleep-aid
Excellent
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep?
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=23 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=20 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=18 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=22 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Karolinska Sleep Diary - Sleep Quality
1 = Very poor
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Karolinska Sleep Diary - Sleep Quality
2 = Rather poor
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Karolinska Sleep Diary - Sleep Quality
3 = Neither poor nor good
|
6 Participants
|
11 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
10 Participants
|
|
Karolinska Sleep Diary - Sleep Quality
4 = Rather good
|
11 Participants
|
5 Participants
|
14 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
|
Karolinska Sleep Diary - Sleep Quality
5 = Very good
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep?
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=23 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=20 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=18 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=22 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Karolinska Sleep Diary - Calmness of Sleep
1 = Very restless
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Karolinska Sleep Diary - Calmness of Sleep
2 = Rather restless
|
1 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
|
Karolinska Sleep Diary - Calmness of Sleep
3 = Neither restless nor calm
|
5 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
|
Karolinska Sleep Diary - Calmness of Sleep
4 = Rather calm
|
16 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
|
Karolinska Sleep Diary - Calmness of Sleep
5 = Very calm
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep?
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=23 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=20 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=18 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=22 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Karolinska Sleep Diary - Easiness to Fall Asleep
1 = Very difficult
|
0 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Karolinska Sleep Diary - Easiness to Fall Asleep
2 = Rather difficult
|
3 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
|
Karolinska Sleep Diary - Easiness to Fall Asleep
3 = Neither difficult nor easy
|
10 Participants
|
11 Participants
|
11 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
|
Karolinska Sleep Diary - Easiness to Fall Asleep
4 = Rather easy
|
8 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
9 Participants
|
|
Karolinska Sleep Diary - Easiness to Fall Asleep
5 = Very easy
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening?
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=23 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=20 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=18 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=22 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Karolinska Sleep Diary - Premature Awakening
1 = Woke up much too early
|
5 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
|
Karolinska Sleep Diary - Premature Awakening
2 = Woke up somewhat too early
|
8 Participants
|
10 Participants
|
12 Participants
|
7 Participants
|
6 Participants
|
13 Participants
|
|
Karolinska Sleep Diary - Premature Awakening
3 = No
|
9 Participants
|
6 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening?
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=23 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=20 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=18 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=22 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Karolinska Sleep Diary - Ease of Awakening
1 = Very difficult
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Karolinska Sleep Diary - Ease of Awakening
2 = Rather difficult
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Karolinska Sleep Diary - Ease of Awakening
3 = Neither difficult nor easy
|
1 Participants
|
7 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Karolinska Sleep Diary - Ease of Awakening
4 = Rather easy
|
15 Participants
|
8 Participants
|
8 Participants
|
15 Participants
|
9 Participants
|
14 Participants
|
|
Karolinska Sleep Diary - Ease of Awakening
5 = Very easy
|
5 Participants
|
6 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested?
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=23 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=20 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=18 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=22 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Karolinska Sleep Diary - Well Rested
1 = Not rested at all
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Karolinska Sleep Diary - Well Rested
2 = Somewhat unrested
|
13 Participants
|
14 Participants
|
14 Participants
|
12 Participants
|
14 Participants
|
17 Participants
|
|
Karolinska Sleep Diary - Well Rested
3 = Completely rested
|
8 Participants
|
4 Participants
|
9 Participants
|
8 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep?
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=22 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=23 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=20 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=18 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=22 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Karolinska Sleep Diary - Sufficient Sleep
1 = No, definitely too little
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Karolinska Sleep Diary - Sufficient Sleep
2 = No, much too little
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Karolinska Sleep Diary - Sufficient Sleep
3 = No, somewhat too little
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
|
Karolinska Sleep Diary - Sufficient Sleep
4 = Yes, almost enough
|
10 Participants
|
8 Participants
|
14 Participants
|
10 Participants
|
4 Participants
|
12 Participants
|
|
Karolinska Sleep Diary - Sufficient Sleep
5 = Yes, definitely enough
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
Subject responded to: Please estimate the number of hours and minutes you think that you slept.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Total Sleep Time by Subject Assessment
|
306.32 Minutes
Interval 231.0 to 381.0
|
309.97 Minutes
Interval 235.0 to 385.0
|
339.08 Minutes
Interval 264.0 to 414.0
|
309.23 Minutes
Interval 234.0 to 384.0
|
160.49 Minutes
Interval 85.0 to 236.0
|
299.58 Minutes
Interval 223.0 to 376.0
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed).
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).
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Sleep Quality Index
|
3.49 Scores on a scale
Interval 3.1 to 3.9
|
2.89 Scores on a scale
Interval 2.5 to 3.3
|
3.40 Scores on a scale
Interval 3.0 to 3.8
|
3.12 Scores on a scale
Interval 2.7 to 3.5
|
2.96 Scores on a scale
Interval 2.6 to 3.4
|
3.37 Scores on a scale
Interval 3.0 to 3.7
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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).
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Overall Rating of Severity in Categorical Pain Rating Scale Score
Baseline
|
2.44 Scores on a scale
Standard Deviation 0.51
|
2.48 Scores on a scale
Standard Deviation 0.51
|
2.48 Scores on a scale
Standard Deviation 0.51
|
2.48 Scores on a scale
Standard Deviation 0.51
|
2.37 Scores on a scale
Standard Deviation 0.49
|
2.22 Scores on a scale
Standard Deviation 0.42
|
|
Overall Rating of Severity in Categorical Pain Rating Scale Score
Post-Baseline
|
1.26 Scores on a scale
Standard Deviation 1.02
|
1.48 Scores on a scale
Standard Deviation 1.05
|
1.26 Scores on a scale
Standard Deviation 0.94
|
1.78 Scores on a scale
Standard Deviation 0.97
|
2.67 Scores on a scale
Standard Deviation 0.62
|
1.41 Scores on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline and up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Categorical Pain Rating Scale Score
|
-1.2 Scores on a scale
Interval -1.5 to -0.8
|
-1.0 Scores on a scale
Interval -1.3 to -0.6
|
-1.2 Scores on a scale
Interval -1.5 to -0.8
|
-0.7 Scores on a scale
Interval -1.0 to -0.3
|
0.3 Scores on a scale
Interval -0.1 to 0.6
|
-0.9 Scores on a scale
Interval -1.3 to -0.6
|
SECONDARY outcome
Timeframe: At 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Overall Rating of Severity in Visual Analog Scale (VAS) Score
Baseline
|
76.11 Scores on a scale
Standard Deviation 11.6
|
77.26 Scores on a scale
Standard Deviation 13.1
|
78.19 Scores on a scale
Standard Deviation 13.4
|
73.70 Scores on a scale
Standard Deviation 12.3
|
79.15 Scores on a scale
Standard Deviation 9.76
|
73.11 Scores on a scale
Standard Deviation 10.5
|
|
Overall Rating of Severity in Visual Analog Scale (VAS) Score
Post-Baseline
|
32.11 Scores on a scale
Standard Deviation 31.1
|
40.30 Scores on a scale
Standard Deviation 33.0
|
30.33 Scores on a scale
Standard Deviation 28.6
|
48.59 Scores on a scale
Standard Deviation 33.4
|
84.26 Scores on a scale
Standard Deviation 19.9
|
38.19 Scores on a scale
Standard Deviation 32.9
|
SECONDARY outcome
Timeframe: Baseline and up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) Score
|
-44.04 Scores on a scale
Interval -55.1 to -33.0
|
-36.65 Scores on a scale
Interval -47.7 to -25.6
|
-47.26 Scores on a scale
Interval -58.4 to -36.2
|
-25.89 Scores on a scale
Interval -37.0 to -14.8
|
6.00 Scores on a scale
Interval -5.1 to 17.1
|
-35.89 Scores on a scale
Interval -47.0 to -24.8
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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).
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Overall Rating of Pain Relief
No relief
|
1 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
11 Participants
|
4 Participants
|
|
Overall Rating of Pain Relief
A little relief
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
|
Overall Rating of Pain Relief
Some relief
|
8 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Overall Rating of Pain Relief
A lot relief
|
12 Participants
|
10 Participants
|
13 Participants
|
11 Participants
|
2 Participants
|
13 Participants
|
|
Overall Rating of Pain Relief
Complete relief
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Time to Rescue Medication
|
NA Minutes
Technically the data is not computable due to insufficient number of events
|
NA Minutes
Technically the data is not computable due to insufficient number of events
|
NA Minutes
Technically the data is not computable due to insufficient number of events
|
NA Minutes
Technically the data is not computable due to insufficient number of events
|
NA Minutes
Technically the data is not computable due to insufficient number of events
|
NA Minutes
Technically the data is not computable due to insufficient number of events
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Cumulative Proportion of Participants Taking Rescue Medication by Hour
1 hour
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Cumulative Proportion of Participants Taking Rescue Medication by Hour
2 hours
|
6 Participants
|
9 Participants
|
5 Participants
|
9 Participants
|
17 Participants
|
7 Participants
|
|
Cumulative Proportion of Participants Taking Rescue Medication by Hour
3 hours
|
8 Participants
|
11 Participants
|
5 Participants
|
9 Participants
|
20 Participants
|
7 Participants
|
|
Cumulative Proportion of Participants Taking Rescue Medication by Hour
4 hours
|
10 Participants
|
11 Participants
|
5 Participants
|
10 Participants
|
21 Participants
|
7 Participants
|
|
Cumulative Proportion of Participants Taking Rescue Medication by Hour
5 hours
|
11 Participants
|
11 Participants
|
5 Participants
|
11 Participants
|
24 Participants
|
7 Participants
|
|
Cumulative Proportion of Participants Taking Rescue Medication by Hour
6 hours
|
11 Participants
|
11 Participants
|
6 Participants
|
12 Participants
|
25 Participants
|
9 Participants
|
|
Cumulative Proportion of Participants Taking Rescue Medication by Hour
7 hours
|
11 Participants
|
12 Participants
|
7 Participants
|
13 Participants
|
25 Participants
|
10 Participants
|
|
Cumulative Proportion of Participants Taking Rescue Medication by Hour
8 hours
|
11 Participants
|
12 Participants
|
7 Participants
|
13 Participants
|
25 Participants
|
10 Participants
|
|
Cumulative Proportion of Participants Taking Rescue Medication by Hour
9 hours
|
11 Participants
|
12 Participants
|
8 Participants
|
13 Participants
|
25 Participants
|
11 Participants
|
|
Cumulative Proportion of Participants Taking Rescue Medication by Hour
10 hours
|
12 Participants
|
12 Participants
|
8 Participants
|
13 Participants
|
25 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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)
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Global Assessment of Study Medication as a Pain Reliever
Poor
|
1 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
15 Participants
|
5 Participants
|
|
Global Assessment of Study Medication as a Pain Reliever
Fair
|
6 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
|
Global Assessment of Study Medication as a Pain Reliever
Good
|
7 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Global Assessment of Study Medication as a Pain Reliever
Very good
|
11 Participants
|
4 Participants
|
9 Participants
|
9 Participants
|
0 Participants
|
11 Participants
|
|
Global Assessment of Study Medication as a Pain Reliever
Excellent
|
2 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Number of Times Participants Took Rescue Medication
0
|
15 Participants
|
15 Participants
|
19 Participants
|
14 Participants
|
2 Participants
|
16 Participants
|
|
Number of Times Participants Took Rescue Medication
1
|
12 Participants
|
12 Participants
|
8 Participants
|
13 Participants
|
22 Participants
|
11 Participants
|
|
Number of Times Participants Took Rescue Medication
2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Times Participants Took Rescue Medication
3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Total Wake Time Measured by Actigraphy
|
253.72 Minutes
Interval 174.0 to 333.0
|
290.03 Minutes
Interval 210.0 to 370.0
|
180.21 Minutes
Interval 100.0 to 260.0
|
285.62 Minutes
Interval 206.0 to 365.0
|
518.58 Minutes
Interval 439.0 to 598.0
|
255.20 Minutes
Interval 175.0 to 336.0
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Sleep Efficiency Measured by Actigraphy
|
57.24 Percentage of sleep time
Interval 44.0 to 71.0
|
51.49 Percentage of sleep time
Interval 38.0 to 65.0
|
68.87 Percentage of sleep time
Interval 55.0 to 82.0
|
52.09 Percentage of sleep time
Interval 39.0 to 66.0
|
12.85 Percentage of sleep time
Interval -1.0 to 26.0
|
56.70 Percentage of sleep time
Interval 43.0 to 70.0
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
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.
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Activity Mean Measured by Actigraphy
|
42.09 Movement per minute
Interval 25.0 to 59.0
|
48.48 Movement per minute
Interval 32.0 to 65.0
|
26.73 Movement per minute
Interval 10.0 to 43.0
|
52.36 Movement per minute
Interval 36.0 to 69.0
|
72.43 Movement per minute
Interval 56.0 to 89.0
|
41.14 Movement per minute
Interval 24.0 to 58.0
|
SECONDARY outcome
Timeframe: Up to 10 hoursActigraphy 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).
Outcome measures
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 Participants
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 Participants
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 Participants
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 Participants
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 Participants
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Wake Episode Measured by Actigraphy
|
8.38 Wake episodes
Interval 5.0 to 11.0
|
10.86 Wake episodes
Interval 8.0 to 14.0
|
13.26 Wake episodes
Interval 10.0 to 16.0
|
9.89 Wake episodes
Interval 7.0 to 13.0
|
5.84 Wake episodes
Interval 3.0 to 9.0
|
11.98 Wake episodes
Interval 9.0 to 15.0
|
Adverse Events
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Naproxen Sodium 440 mg (BAYH6689)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Naproxen Sodium 220 mg (BAYH6689)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DPH 50mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
n=27 participants at risk
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
|
Naproxen Sodium 440 mg (BAYH6689)
n=27 participants at risk
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
|
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
n=27 participants at risk
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.
|
Naproxen Sodium 220 mg (BAYH6689)
n=27 participants at risk
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
|
DPH 50mg
n=27 participants at risk
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
|
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
n=27 participants at risk
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
NAUSEA
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
7.4%
2/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
7.4%
2/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
7.4%
2/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
PYREXIA
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
1/27 • Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place