Trial Outcomes & Findings for Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain (NCT NCT01280591)
NCT ID: NCT01280591
Last Updated: 2015-06-08
Results Overview
WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
712 participants
Primary outcome timeframe
Up to 10 hours
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
DPH 50 mg
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
203
|
204
|
203
|
102
|
|
Overall Study
COMPLETED
|
203
|
204
|
203
|
99
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
DPH 50 mg
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
|
Overall Study
Does not meet exclusion #27 criteria
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Baseline characteristics by cohort
| Measure |
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=203 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=204 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=203 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
DPH 50 mg
n=102 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Total
n=712 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
21.4 Years
STANDARD_DEVIATION 4.87 • n=99 Participants
|
21.0 Years
STANDARD_DEVIATION 4.25 • n=107 Participants
|
21.0 Years
STANDARD_DEVIATION 4.50 • n=206 Participants
|
21.5 Years
STANDARD_DEVIATION 5.59 • n=7 Participants
|
21.2 Years
STANDARD_DEVIATION 4.70 • n=31 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
403 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
309 Participants
n=31 Participants
|
|
Baseline Categorical Pain Rating Scale
No pain
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Baseline Categorical Pain Rating Scale
Mild pain
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Baseline Categorical Pain Rating Scale
Moderate pain
|
146 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
74 Participants
n=7 Participants
|
494 Participants
n=31 Participants
|
|
Baseline Categorical Pain Rating Scale
Severe pain
|
57 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
218 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Outcome measures
| Measure |
DPH 50 mg
n=102 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=203 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=204 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=203 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Wake Time After Sleep Onset (WASO) Measured by Actigraphy
|
431.4 Minutes
Interval 395.1 to 467.6
|
143.7 Minutes
Interval 117.9 to 169.6
|
230.9 Minutes
Interval 205.2 to 256.5
|
214.0 Minutes
Interval 188.2 to 239.8
|
PRIMARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Outcome measures
| Measure |
DPH 50 mg
n=102 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=203 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=204 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=203 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Sleep Latency Measured by Actigraphy
|
41.50 Minutes
Interval 26.5 to 54.5
|
25.50 Minutes
Interval 22.5 to 30.0
|
30.25 Minutes
Interval 25.0 to 33.5
|
25.75 Minutes
Interval 22.5 to 29.5
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Outcome measures
| Measure |
DPH 50 mg
n=102 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=203 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=204 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=203 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Total Sleep Time Measured by Actigraphy
|
141.4 Minutes
Interval 106.0 to 176.8
|
426.2 Minutes
Interval 400.9 to 451.4
|
337.7 Minutes
Interval 312.6 to 362.7
|
355.8 Minutes
Interval 330.6 to 381.0
|
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 |
DPH 50 mg
n=102 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=203 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=204 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=203 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Sleep Efficiency Measured by Actigraphy
|
23.6 Percent of sleep time during in-bed time
Interval 17.7 to 29.5
|
71.0 Percent of sleep time during in-bed time
Interval 66.8 to 75.2
|
56.3 Percent of sleep time during in-bed time
Interval 52.1 to 60.5
|
59.3 Percent of sleep time during in-bed time
Interval 55.1 to 63.5
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).
Outcome measures
| Measure |
DPH 50 mg
n=25 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=166 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=125 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=141 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Global Assessment of Investigational Product as a Sleep Aid
0 = Poor
|
3 Participants
|
8 Participants
|
10 Participants
|
29 Participants
|
|
Global Assessment of Investigational Product as a Sleep Aid
1 = Fair
|
9 Participants
|
39 Participants
|
29 Participants
|
51 Participants
|
|
Global Assessment of Investigational Product as a Sleep Aid
2 = Good
|
6 Participants
|
58 Participants
|
47 Participants
|
37 Participants
|
|
Global Assessment of Investigational Product as a Sleep Aid
3 = Very good
|
7 Participants
|
49 Participants
|
26 Participants
|
17 Participants
|
|
Global Assessment of Investigational Product as a Sleep Aid
4 = Excellent
|
0 Participants
|
12 Participants
|
13 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)
Outcome measures
| Measure |
DPH 50 mg
n=46 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=188 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=170 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=180 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Karolinska Sleep Diary - Sleep Quality
1 = Very poor
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Karolinska Sleep Diary - Sleep Quality
2 = Rather poor
|
10 Participants
|
23 Participants
|
24 Participants
|
39 Participants
|
|
Karolinska Sleep Diary - Sleep Quality
3 = Neither poor nor good
|
13 Participants
|
46 Participants
|
52 Participants
|
69 Participants
|
|
Karolinska Sleep Diary - Sleep Quality
4 = Rather good
|
18 Participants
|
82 Participants
|
68 Participants
|
55 Participants
|
|
Karolinska Sleep Diary - Sleep Quality
5 = Very good
|
2 Participants
|
34 Participants
|
21 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)
Outcome measures
| Measure |
DPH 50 mg
n=46 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=188 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=170 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=180 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Karolinska Sleep Diary - Calmness of Sleep
1 = Very restless
|
5 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
|
Karolinska Sleep Diary - Calmness of Sleep
2 = Rather restless
|
16 Participants
|
35 Participants
|
29 Participants
|
48 Participants
|
|
Karolinska Sleep Diary - Calmness of Sleep
3 = Neither restless nor calm
|
10 Participants
|
37 Participants
|
39 Participants
|
42 Participants
|
|
Karolinska Sleep Diary - Calmness of Sleep
4 = Rather calm
|
12 Participants
|
76 Participants
|
68 Participants
|
61 Participants
|
|
Karolinska Sleep Diary - Calmness of Sleep
5 = Very calm
|
3 Participants
|
32 Participants
|
26 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)
Outcome measures
| Measure |
DPH 50 mg
n=46 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=188 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=170 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=180 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Karolinska Sleep Diary - Easiness to Fall Asleep
1 = Very difficult
|
8 Participants
|
8 Participants
|
11 Participants
|
12 Participants
|
|
Karolinska Sleep Diary - Easiness to Fall Asleep
2 = Rather difficult
|
16 Participants
|
41 Participants
|
45 Participants
|
59 Participants
|
|
Karolinska Sleep Diary - Easiness to Fall Asleep
3 = Neither difficult nor easy
|
10 Participants
|
57 Participants
|
57 Participants
|
55 Participants
|
|
Karolinska Sleep Diary - Easiness to Fall Asleep
4 = Rather easy
|
9 Participants
|
62 Participants
|
42 Participants
|
41 Participants
|
|
Karolinska Sleep Diary - Easiness to Fall Asleep
5 = Very easy
|
3 Participants
|
20 Participants
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)
Outcome measures
| Measure |
DPH 50 mg
n=46 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=188 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=170 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=180 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Karolinska Sleep Diary - Premature Awakening
1 = Woke up much too early
|
23 Participants
|
40 Participants
|
54 Participants
|
65 Participants
|
|
Karolinska Sleep Diary - Premature Awakening
2 = Woke up somewhat too early
|
17 Participants
|
77 Participants
|
59 Participants
|
80 Participants
|
|
Karolinska Sleep Diary - Premature Awakening
3 = No
|
6 Participants
|
71 Participants
|
57 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)
Outcome measures
| Measure |
DPH 50 mg
n=46 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=188 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=170 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=180 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Karolinska Sleep Diary - Ease of Awakening
1 = Very difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Karolinska Sleep Diary - Ease of Awakening
2 = Rather difficult
|
1 Participants
|
7 Participants
|
4 Participants
|
2 Participants
|
|
Karolinska Sleep Diary - Ease of Awakening
3 = Neither difficult nor easy
|
10 Participants
|
28 Participants
|
24 Participants
|
33 Participants
|
|
Karolinska Sleep Diary - Ease of Awakening
4 = Rather easy
|
15 Participants
|
98 Participants
|
94 Participants
|
88 Participants
|
|
Karolinska Sleep Diary - Ease of Awakening
5 = Very easy
|
20 Participants
|
55 Participants
|
48 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)
Outcome measures
| Measure |
DPH 50 mg
n=46 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=188 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=170 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=180 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Karolinska Sleep Diary - Well Rested
1 = Not rested at all
|
8 Participants
|
9 Participants
|
21 Participants
|
16 Participants
|
|
Karolinska Sleep Diary - Well Rested
2 = Somewhat unrested
|
31 Participants
|
100 Participants
|
95 Participants
|
116 Participants
|
|
Karolinska Sleep Diary - Well Rested
3 = Completely rested
|
7 Participants
|
79 Participants
|
54 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)
Outcome measures
| Measure |
DPH 50 mg
n=46 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=188 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=170 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=180 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Karolinska Sleep Diary - Sufficient Sleep
1 = No, definitely too little
|
10 Participants
|
7 Participants
|
21 Participants
|
18 Participants
|
|
Karolinska Sleep Diary - Sufficient Sleep
2 = No, much too little
|
8 Participants
|
14 Participants
|
24 Participants
|
22 Participants
|
|
Karolinska Sleep Diary - Sufficient Sleep
3 = No, somewhat too little
|
14 Participants
|
37 Participants
|
40 Participants
|
56 Participants
|
|
Karolinska Sleep Diary - Sufficient Sleep
4 = Yes, almost enough
|
9 Participants
|
84 Participants
|
52 Participants
|
58 Participants
|
|
Karolinska Sleep Diary - Sufficient Sleep
5 = Yes, definitely enough
|
5 Participants
|
46 Participants
|
33 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent)
Outcome measures
| Measure |
DPH 50 mg
n=45 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=183 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=162 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=174 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Subjective Sleep Questionnaire - Quality of Your Sleep Last Night
|
4.9 Scores on a scale
Standard Deviation 2.36
|
6.4 Scores on a scale
Standard Deviation 1.96
|
5.9 Scores on a scale
Standard Deviation 2.13
|
5.4 Scores on a scale
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)
Outcome measures
| Measure |
DPH 50 mg
n=45 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=171 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=161 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=170 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night
|
4.4 Scores on a scale
Standard Deviation 2.45
|
6.2 Scores on a scale
Standard Deviation 2.03
|
5.8 Scores on a scale
Standard Deviation 2.26
|
5.5 Scores on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to Estimate of how long it took to fall asleep (minutes)
Outcome measures
| Measure |
DPH 50 mg
n=46 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=188 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=170 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=180 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Subjective Sleep Questionnaire - Time to Fall Asleep Last Night
|
42.4 Minutes
Standard Deviation 42.02
|
40.0 Minutes
Standard Deviation 31.52
|
40.7 Minutes
Standard Deviation 29.39
|
53.4 Minutes
Standard Deviation 67.78
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)
Outcome measures
| Measure |
DPH 50 mg
n=46 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=188 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=170 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=180 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed
|
81.7 Minutes
Standard Deviation 86.72
|
73.8 Minutes
Standard Deviation 79.06
|
75.3 Minutes
Standard Deviation 81.55
|
103.5 Minutes
Standard Deviation 89.50
|
SECONDARY outcome
Timeframe: Baseline and up to 10 hoursPopulation: ITT (Intent to Treat) Population
Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain
Outcome measures
| Measure |
DPH 50 mg
n=102 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=203 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=204 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=203 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Change From Baseline in Pain Intensity
|
0.1 Scores on a scale
Standard Deviation 0.82
|
-1.2 Scores on a scale
Standard Deviation 1.01
|
-0.7 Scores on a scale
Standard Deviation 1.05
|
-0.9 Scores on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement "Overall, the relief from my starting pain was": no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4).
Outcome measures
| Measure |
DPH 50 mg
n=102 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=203 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=204 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=202 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Overall Rating of Pain Relief
0 = No relief
|
79 Participants
|
44 Participants
|
89 Participants
|
68 Participants
|
|
Overall Rating of Pain Relief
1 = A little relief
|
1 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Overall Rating of Pain Relief
2 = Some relief
|
11 Participants
|
32 Participants
|
29 Participants
|
24 Participants
|
|
Overall Rating of Pain Relief
3 = A lot of relief
|
8 Participants
|
65 Participants
|
53 Participants
|
62 Participants
|
|
Overall Rating of Pain Relief
4 = Complete relief
|
3 Participants
|
58 Participants
|
29 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population
If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded
Outcome measures
| Measure |
DPH 50 mg
n=102 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=203 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=204 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=203 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Time to Rescue Medication
|
113.5 Minutes
Interval 98.5 to 144.5
|
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: Safety Population
If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded
Outcome measures
| Measure |
DPH 50 mg
n=102 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=203 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=204 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=203 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
≤ 60 minutes
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
≤ 120 minutes
|
53 participants
|
18 participants
|
36 participants
|
27 participants
|
|
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
≤ 180 minutes
|
66 participants
|
23 participants
|
50 participants
|
41 participants
|
|
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
≤ 240 minutes
|
70 participants
|
25 participants
|
57 participants
|
47 participants
|
|
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
≤ 300 minutes
|
74 participants
|
29 participants
|
65 participants
|
50 participants
|
|
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
≤ 360 minutes
|
76 participants
|
34 participants
|
69 participants
|
55 participants
|
|
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
≤ 420 minutes
|
77 participants
|
36 participants
|
78 participants
|
62 participants
|
|
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
≤ 480 minutes
|
78 participants
|
39 participants
|
83 participants
|
63 participants
|
|
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
≤ 540 minutes
|
78 participants
|
42 participants
|
87 participants
|
67 participants
|
|
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
≤ 600 minutes
|
78 participants
|
43 participants
|
89 participants
|
68 participants
|
SECONDARY outcome
Timeframe: Up to 10 hoursPopulation: ITT (Intent to Treat) Population with available data (missing values were not imputed)
The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).
Outcome measures
| Measure |
DPH 50 mg
n=25 Participants
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=166 Participants
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=126 Participants
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=141 Participants
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
|---|---|---|---|---|
|
Global Assessment of Investigational Product as a Pain Reliever
0 = Poor
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Global Assessment of Investigational Product as a Pain Reliever
1 = Fair
|
5 Participants
|
9 Participants
|
16 Participants
|
15 Participants
|
|
Global Assessment of Investigational Product as a Pain Reliever
2 = Good
|
9 Participants
|
43 Participants
|
35 Participants
|
36 Participants
|
|
Global Assessment of Investigational Product as a Pain Reliever
3 = Very good
|
7 Participants
|
64 Participants
|
48 Participants
|
56 Participants
|
|
Global Assessment of Investigational Product as a Pain Reliever
4 = Excellent
|
0 Participants
|
48 Participants
|
25 Participants
|
34 Participants
|
Adverse Events
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Naproxen Sodium 440 mg (BAYH6689)
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
DPH 50 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
n=203 participants at risk
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
|
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
n=204 participants at risk
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
|
Naproxen Sodium 440 mg (BAYH6689)
n=203 participants at risk
Participants received two Naproxen sodium 220 mg tablets orally, single dose
|
DPH 50 mg
n=102 participants at risk
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.98%
1/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Nausea
|
7.4%
15/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
5.9%
12/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
6.9%
14/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
8.8%
9/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
2/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
2.5%
5/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.0%
6/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.9%
4/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
Chills
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
Feeling cold
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
Feeling hot
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.98%
1/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
Pyrexia
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.98%
1/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
Dizziness
|
4.4%
9/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.4%
7/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
2.5%
5/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.9%
4/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
Headache
|
5.9%
12/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
6.4%
13/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
7.4%
15/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
7.8%
8/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
Paraesthesia
|
1.5%
3/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
2.0%
2/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
Presyncope
|
1.5%
3/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
1.5%
3/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.99%
2/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.98%
1/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
Syncope
|
0.99%
2/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.99%
2/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
Tremor
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.98%
1/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
1.5%
3/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.98%
1/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Vascular disorders
Flushing
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Vascular disorders
Hypertension
|
0.49%
1/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.49%
1/204 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/203 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/102 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 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