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Trial record 47 of 449 for:    diphenhydramine

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain (Morpheus II)

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ClinicalTrials.gov Identifier: NCT01280591
Recruitment Status : Completed
First Posted : January 21, 2011
Results First Posted : June 17, 2014
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pain, Postoperative
Interventions Drug: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)
Drug: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)
Drug: Naproxen sodium 440 mg (BAYH6689)
Drug: DPH 50 mg
Enrollment 712
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose Participants received two Naproxen sodium 220 mg tablets orally, single dose Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Period Title: Overall Study
Started 203 204 203 102
Completed 203 204 203 99
Not Completed 0 0 0 3
Reason Not Completed
Withdrawal by Subject             0             0             0             2
Does not meet exclusion #27 criteria             0             0             0             1
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg Total
Hide Arm/Group Description Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose Participants received two Naproxen sodium 220 mg tablets orally, single dose Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose Total of all reporting groups
Overall Number of Baseline Participants 203 204 203 102 712
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 203 participants 204 participants 203 participants 102 participants 712 participants
21.4  (4.87) 21.0  (4.25) 21.0  (4.50) 21.5  (5.59) 21.2  (4.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 204 participants 203 participants 102 participants 712 participants
Female
108
  53.2%
124
  60.8%
117
  57.6%
54
  52.9%
403
  56.6%
Male
95
  46.8%
80
  39.2%
86
  42.4%
48
  47.1%
309
  43.4%
Baseline Categorical Pain Rating Scale  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 203 participants 204 participants 203 participants 102 participants 712 participants
No pain 0 0 0 0 0
Mild pain 0 0 0 0 0
Moderate pain 146 134 140 74 494
Severe pain 57 70 63 28 218
1.Primary Outcome
Title Wake Time After Sleep Onset (WASO) Measured by Actigraphy
Hide Description WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 203 204 203 102
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Minutes
143.7
(117.9 to 169.6)
230.9
(205.2 to 256.5)
214.0
(188.2 to 239.8)
431.4
(395.1 to 467.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -70.3
Confidence Interval (2-Sided) 95%
-106.8 to -33.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 13.17
Estimation Comments [Not Specified]
2.Primary Outcome
Title Sleep Latency Measured by Actigraphy
Hide Description Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 203 204 203 102
Median (95% Confidence Interval)
Unit of Measure: Minutes
25.50
(22.50 to 30.00)
30.25
(25.00 to 33.50)
25.75
(22.50 to 29.50)
41.50
(26.50 to 54.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), DPH 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Total Sleep Time Measured by Actigraphy
Hide Description Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 203 204 203 102
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Minutes
426.2
(400.9 to 451.4)
337.7
(312.6 to 362.7)
355.8
(330.6 to 381.0)
141.4
(106.0 to 176.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 70.4
Confidence Interval (2-Sided) 95%
28.1 to 112.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 12.85
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Sleep Efficiency Measured by Actigraphy
Hide Description Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 203 204 203 102
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent of sleep time during in-bed time
71.0
(66.8 to 75.2)
56.3
(52.1 to 60.5)
59.3
(55.1 to 63.5)
23.6
(17.7 to 29.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.7
Confidence Interval (2-Sided) 95%
3.7 to 19.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.14
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Global Assessment of Investigational Product as a Sleep Aid
Hide Description The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 166 125 141 25
Measure Type: Number
Unit of Measure: Participants
0 = Poor 8 10 29 3
1 = Fair 39 29 51 9
2 = Good 58 47 37 6
3 = Very good 49 26 17 7
4 = Excellent 12 13 7 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Karolinska Sleep Diary - Sleep Quality
Hide Description Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 188 170 180 46
Measure Type: Number
Unit of Measure: Participants
1 = Very poor 3 5 5 3
2 = Rather poor 23 24 39 10
3 = Neither poor nor good 46 52 69 13
4 = Rather good 82 68 55 18
5 = Very good 34 21 12 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Karolinska Sleep Diary - Calmness of Sleep
Hide Description Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 188 170 180 46
Measure Type: Number
Unit of Measure: Participants
1 = Very restless 8 8 7 5
2 = Rather restless 35 29 48 16
3 = Neither restless nor calm 37 39 42 10
4 = Rather calm 76 68 61 12
5 = Very calm 32 26 22 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0321
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
8.Secondary Outcome
Title Karolinska Sleep Diary - Easiness to Fall Asleep
Hide Description Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 188 170 180 46
Measure Type: Number
Unit of Measure: Participants
1 = Very difficult 8 11 12 8
2 = Rather difficult 41 45 59 16
3 = Neither difficult nor easy 57 57 55 10
4 = Rather easy 62 42 41 9
5 = Very easy 20 15 13 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
9.Secondary Outcome
Title Karolinska Sleep Diary - Premature Awakening
Hide Description Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 188 170 180 46
Measure Type: Number
Unit of Measure: Participants
1 = Woke up much too early 40 54 65 23
2 = Woke up somewhat too early 77 59 80 17
3 = No 71 57 35 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
10.Secondary Outcome
Title Karolinska Sleep Diary - Ease of Awakening
Hide Description Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 188 170 180 46
Measure Type: Number
Unit of Measure: Participants
1 = Very difficult 0 0 1 0
2 = Rather difficult 7 4 2 1
3 = Neither difficult nor easy 28 24 33 10
4 = Rather easy 98 94 88 15
5 = Very easy 55 48 56 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
11.Secondary Outcome
Title Karolinska Sleep Diary - Well Rested
Hide Description Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 188 170 180 46
Measure Type: Number
Unit of Measure: Participants
1 = Not rested at all 9 21 16 8
2 = Somewhat unrested 100 95 116 31
3 = Completely rested 79 54 48 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
12.Secondary Outcome
Title Karolinska Sleep Diary - Sufficient Sleep
Hide Description Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 188 170 180 46
Measure Type: Number
Unit of Measure: Participants
1 = No, definitely too little 7 21 18 10
2 = No, much too little 14 24 22 8
3 = No, somewhat too little 37 40 56 14
4 = Yes, almost enough 84 52 58 9
5 = Yes, definitely enough 46 33 26 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
13.Secondary Outcome
Title Subjective Sleep Questionnaire - Quality of Your Sleep Last Night
Hide Description Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 183 162 174 45
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
6.4  (1.96) 5.9  (2.13) 5.4  (1.99) 4.9  (2.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
14.Secondary Outcome
Title Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night
Hide Description Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 171 161 170 45
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
6.2  (2.03) 5.8  (2.26) 5.5  (2.14) 4.4  (2.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
15.Secondary Outcome
Title Subjective Sleep Questionnaire - Time to Fall Asleep Last Night
Hide Description Subjects responded to Estimate of how long it took to fall asleep (minutes)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 188 170 180 46
Mean (Standard Deviation)
Unit of Measure: Minutes
40.0  (31.52) 40.7  (29.39) 53.4  (67.78) 42.4  (42.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
16.Secondary Outcome
Title 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
Hide Description Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 188 170 180 46
Mean (Standard Deviation)
Unit of Measure: Minutes
73.8  (79.06) 75.3  (81.55) 103.5  (89.50) 81.7  (86.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Pain Intensity
Hide Description Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain
Time Frame Baseline and up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 203 204 203 102
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.2  (1.01) -0.7  (1.05) -0.9  (0.99) 0.1  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
18.Secondary Outcome
Title Overall Rating of Pain Relief
Hide Description The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement "Overall, the relief from my starting pain was": no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4).
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 203 204 202 102
Measure Type: Number
Unit of Measure: Participants
0 = No relief 44 89 68 79
1 = A little relief 4 4 8 1
2 = Some relief 32 29 24 11
3 = A lot of relief 65 53 62 8
4 = Complete relief 58 29 40 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
19.Secondary Outcome
Title Time to Rescue Medication
Hide Description If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 203 204 203 102
Median (95% Confidence Interval)
Unit of Measure: Minutes
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
113.5
(98.50 to 144.50)
[1]
Technically the data is not computable due to insufficient number of events
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0053
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
20.Secondary Outcome
Title Cumulative Proportion of Subjects Taking Rescue Medication by Hour
Hide Description If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 203 204 203 102
Measure Type: Number
Unit of Measure: participants
≤ 60 minutes 0 1 0 0
≤ 120 minutes 18 36 27 53
≤ 180 minutes 23 50 41 66
≤ 240 minutes 25 57 47 70
≤ 300 minutes 29 65 50 74
≤ 360 minutes 34 69 55 76
≤ 420 minutes 36 78 62 77
≤ 480 minutes 39 83 63 78
≤ 540 minutes 42 87 67 78
≤ 600 minutes 43 89 68 78
21.Secondary Outcome
Title Global Assessment of Investigational Product as a Pain Reliever
Hide Description The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population with available data (missing values were not imputed)
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Participants received two Naproxen sodium 220 mg tablets orally, single dose
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Overall Number of Participants Analyzed 166 126 141 25
Measure Type: Number
Unit of Measure: Participants
0 = Poor 2 2 0 4
1 = Fair 9 16 15 5
2 = Good 43 35 36 9
3 = Very good 64 48 56 7
4 = Excellent 48 25 34 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2734
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame 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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose Participants received two Naproxen sodium 220 mg tablets orally, single dose Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
All-Cause Mortality
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/203 (0.00%)   0/204 (0.00%)   0/203 (0.00%)   0/102 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/203 (18.23%)   37/204 (18.14%)   40/203 (19.70%)   25/102 (24.51%) 
Cardiac disorders         
Tachycardia * 1  0/203 (0.00%)  1/204 (0.49%)  1/203 (0.49%)  0/102 (0.00%) 
Ear and labyrinth disorders         
Ear pain * 1  0/203 (0.00%)  0/204 (0.00%)  0/203 (0.00%)  1/102 (0.98%) 
Gastrointestinal disorders         
Constipation * 1  0/203 (0.00%)  0/204 (0.00%)  1/203 (0.49%)  0/102 (0.00%) 
Dyspepsia * 1  0/203 (0.00%)  0/204 (0.00%)  1/203 (0.49%)  0/102 (0.00%) 
Nausea * 1  15/203 (7.39%)  12/204 (5.88%)  14/203 (6.90%)  9/102 (8.82%) 
Vomiting * 1  2/203 (0.99%)  5/204 (2.45%)  6/203 (2.96%)  4/102 (3.92%) 
General disorders         
Chills * 1  1/203 (0.49%)  0/204 (0.00%)  0/203 (0.00%)  0/102 (0.00%) 
Feeling cold * 1  0/203 (0.00%)  0/204 (0.00%)  1/203 (0.49%)  0/102 (0.00%) 
Feeling hot * 1  1/203 (0.49%)  1/204 (0.49%)  1/203 (0.49%)  1/102 (0.98%) 
Pyrexia * 1  1/203 (0.49%)  1/204 (0.49%)  0/203 (0.00%)  0/102 (0.00%) 
Infections and infestations         
Nasopharyngitis * 1  0/203 (0.00%)  1/204 (0.49%)  0/203 (0.00%)  0/102 (0.00%) 
Injury, poisoning and procedural complications         
Post procedural haemorrhage * 1  0/203 (0.00%)  0/204 (0.00%)  1/203 (0.49%)  0/102 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle tightness * 1  0/203 (0.00%)  0/204 (0.00%)  0/203 (0.00%)  1/102 (0.98%) 
Nervous system disorders         
Dizziness * 1  9/203 (4.43%)  7/204 (3.43%)  5/203 (2.46%)  4/102 (3.92%) 
Headache * 1  12/203 (5.91%)  13/204 (6.37%)  15/203 (7.39%)  8/102 (7.84%) 
Paraesthesia * 1  3/203 (1.48%)  0/204 (0.00%)  1/203 (0.49%)  2/102 (1.96%) 
Presyncope * 1  3/203 (1.48%)  3/204 (1.47%)  2/203 (0.99%)  1/102 (0.98%) 
Syncope * 1  2/203 (0.99%)  0/204 (0.00%)  2/203 (0.99%)  0/102 (0.00%) 
Tremor * 1  0/203 (0.00%)  0/204 (0.00%)  1/203 (0.49%)  1/102 (0.98%) 
Psychiatric disorders         
Insomnia * 1  0/203 (0.00%)  0/204 (0.00%)  1/203 (0.49%)  0/102 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Alveolitis * 1  1/203 (0.49%)  0/204 (0.00%)  0/203 (0.00%)  0/102 (0.00%) 
Epistaxis * 1  0/203 (0.00%)  1/204 (0.49%)  3/203 (1.48%)  0/102 (0.00%) 
Hiccups * 1  0/203 (0.00%)  0/204 (0.00%)  0/203 (0.00%)  1/102 (0.98%) 
Nasal congestion * 1  1/203 (0.49%)  0/204 (0.00%)  0/203 (0.00%)  0/102 (0.00%) 
Sinus congestion * 1  0/203 (0.00%)  0/204 (0.00%)  1/203 (0.49%)  0/102 (0.00%) 
Skin and subcutaneous tissue disorders         
Hyperhidrosis * 1  1/203 (0.49%)  0/204 (0.00%)  0/203 (0.00%)  0/102 (0.00%) 
Pruritus * 1  0/203 (0.00%)  0/204 (0.00%)  1/203 (0.49%)  0/102 (0.00%) 
Rash * 1  0/203 (0.00%)  0/204 (0.00%)  1/203 (0.49%)  0/102 (0.00%) 
Rash generalised * 1  1/203 (0.49%)  0/204 (0.00%)  0/203 (0.00%)  0/102 (0.00%) 
Urticaria * 1  0/203 (0.00%)  0/204 (0.00%)  1/203 (0.49%)  0/102 (0.00%) 
Vascular disorders         
Flushing * 1  1/203 (0.49%)  0/204 (0.00%)  0/203 (0.00%)  0/102 (0.00%) 
Hypertension * 1  1/203 (0.49%)  1/204 (0.49%)  0/203 (0.00%)  0/102 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01280591     History of Changes
Other Study ID Numbers: 14837
First Submitted: January 20, 2011
First Posted: January 21, 2011
Results First Submitted: January 24, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 8, 2015