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Trial record 50 of 448 for:    diphenhydramine

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

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ClinicalTrials.gov Identifier: NCT01118273
Recruitment Status : Completed
First Posted : May 6, 2010
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 Sleep
Interventions Drug: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
Drug: Naproxen Sodium 440 mg (BAYH6689)
Drug: Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
Drug: Naproxen Sodium 220 mg (BAYH6689)
Drug: DPH 50mg
Drug: Ibuprofen 400 mg / Diphenhydramine citrate 76 mg
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally. Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally. Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Period Title: Overall Study
Started 27 27 27 27 27 27
Completed 27 27 27 27 27 27
Not Completed 0 0 0 0 0 0
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg Naproxen Sodium 440 mg (BAYH6689) Total
Hide Arm/Group Description Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally. Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally. Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally. Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. Total of all reporting groups
Overall Number of Baseline Participants 27 27 27 27 27 27 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 27 participants 27 participants 27 participants 27 participants 162 participants
19  (2.8) 20  (2.8) 19  (2.0) 19  (3.0) 19  (2.5) 20  (2.6) 19  (2.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 27 participants 27 participants 27 participants 27 participants 162 participants
Female
16
  59.3%
15
  55.6%
10
  37.0%
19
  70.4%
12
  44.4%
12
  44.4%
84
  51.9%
Male
11
  40.7%
12
  44.4%
17
  63.0%
8
  29.6%
15
  55.6%
15
  55.6%
78
  48.1%
Baseline Categorical Pain Rating Scale  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 27 participants 27 participants 27 participants 27 participants 162 participants
No pain 0 0 0 0 0 0 0
Mild pain 0 0 0 0 0 0 0
Moderate pain 15 14 14 17 21 14 95
Severe pain 12 13 13 10 6 13 67
1.Primary Outcome
Title Total Sleep Time Measured by Actigraphy
Hide Description Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. In calculating the total sleep time, subjects who took rescue medication were treated as “awake” from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Minutes
339.80
(259 to 420)
304.60
(224 to 385)
413.89
(333 to 494)
308.89
(228 to 389)
76.35
(-4 to 157)
335.68
(254 to 417)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Wake After Sleep Onset (WASO) Measured by Actigraphy
Hide Description Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. WASO was defined as minutes of awake during the period of sleep onset and offset, where sleep onset is the first 20-minute block with 19 minutes of sleep.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Minutes
139.96
(70 to 210)
190.91
(121 to 261)
75.66
(7 to 144)
145.67
(72 to 219)
428.34
(351 to 506)
129.02
(59 to 199)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Sleep Latency Measured by Actigraphy
Hide Description Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Sleep latency was defined as minutes to sleep onset since dosing, where sleep onset was the first 20-minute block with 19 minutes of sleep. For subjects who had not achieved sleep onset (e.g., due to taking rescue medication before achieving sleep onset), sleep latency was considered as censored at the time of wakening.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Minutes
29.17
(9 to 50)
32.81
(12 to 53)
46.77
(27 to 67)
31.58
(10 to 53)
41.05
(18 to 64)
36.38
(16 to 57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, DPH 50mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Global Assessment of Study Medication as a Sleep-aid
Hide Description Subject rating of following question with 0 being poor to 4 being excellent: How would you rate the study medication you received as a sleep aid?
Time Frame Up to 10 hours
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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 22 22 23 20 18 22
Measure Type: Number
Unit of Measure: Participants
Poor 1 6 2 4 6 0
Fair 4 4 3 6 7 6
Good 8 7 7 6 3 9
Very good 5 4 8 3 2 7
Excellent 4 1 3 1 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, DPH 50mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Karolinska Sleep Diary - Sleep Quality
Hide Description Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep?
Time Frame Up to 10 hours
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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 22 22 23 20 18 22
Measure Type: Number
Unit of Measure: Participants
1 = Very poor 1 4 1 1 1 0
2 = Rather poor 2 0 2 2 5 1
3 = Neither poor nor good 6 11 3 7 3 10
4 = Rather good 11 5 14 9 9 9
5 = Very good 2 2 3 1 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, DPH 50mg
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 ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Karolinska Sleep Diary - Calmness of Sleep
Hide Description Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep?
Time Frame Up to 10 hours
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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 22 22 23 20 18 22
Measure Type: Number
Unit of Measure: Participants
1 = Very restless 0 2 1 1 1 0
2 = Rather restless 1 7 6 5 7 7
3 = Neither restless nor calm 5 4 3 7 3 5
4 = Rather calm 16 6 12 6 6 8
5 = Very calm 0 3 1 1 1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, DPH 50mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Karolinska Sleep Diary - Easiness to Fall Asleep
Hide Description Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep?
Time Frame Up to 10 hours
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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 22 22 23 20 18 22
Measure Type: Number
Unit of Measure: Participants
1 = Very difficult 0 5 1 3 1 0
2 = Rather difficult 3 3 2 5 6 5
3 = Neither difficult nor easy 10 11 11 3 7 7
4 = Rather easy 8 2 8 7 4 9
5 = Very easy 1 1 1 2 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Karolinska Sleep Diary - Premature Awakening
Hide Description Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening?
Time Frame Up to 10 hours
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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 22 22 23 20 18 22
Measure Type: Number
Unit of Measure: Participants
1 = Woke up much too early 5 6 2 6 8 5
2 = Woke up somewhat too early 8 10 12 7 6 13
3 = No 9 6 9 7 4 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg, DPH 50mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
9.Secondary Outcome
Title Karolinska Sleep Diary - Ease of Awakening
Hide Description Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening?
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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 22 22 23 20 18 22
Measure Type: Number
Unit of Measure: Participants
1 = Very difficult 0 1 0 1 0 0
2 = Rather difficult 1 0 2 1 1 0
3 = Neither difficult nor easy 1 7 5 1 3 4
4 = Rather easy 15 8 8 15 9 14
5 = Very easy 5 6 8 2 5 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, DPH 50mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
10.Secondary Outcome
Title Karolinska Sleep Diary - Well Rested
Hide Description Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested?
Time Frame Up to 10 hours
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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 22 22 23 20 18 22
Measure Type: Number
Unit of Measure: Participants
1 = Not rested at all 1 4 0 0 3 1
2 = Somewhat unrested 13 14 14 12 14 17
3 = Completely rested 8 4 9 8 1 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, DPH 50mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Karolinska Sleep Diary - Sufficient Sleep
Hide Description Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep?
Time Frame Up to 10 hours
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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 22 22 23 20 18 22
Measure Type: Number
Unit of Measure: Participants
1 = No, definitely too little 1 4 0 1 2 1
2 = No, much too little 4 3 2 1 4 1
3 = No, somewhat too little 4 4 3 4 8 6
4 = Yes, almost enough 10 8 14 10 4 12
5 = Yes, definitely enough 3 3 4 4 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, DPH 50mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
12.Secondary Outcome
Title Total Sleep Time by Subject Assessment
Hide Description Subject responded to: Please estimate the number of hours and minutes you think that you slept.
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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Minutes
306.32
(231 to 381)
309.97
(235 to 385)
339.08
(264 to 414)
309.23
(234 to 384)
160.49
(85 to 236)
299.58
(223 to 376)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Sleep Quality Index
Hide Description Sleep Quality Index is the mean score of items, 'sleep quality', 'calm sleep', 'ease falling asleep', and 'slept throughout' on the Karolinska Sleep Diary, ranges from 1 (worst possible) to 5 (best possible).
Time Frame Up to 10 hours
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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
3.49
(3.1 to 3.9)
2.89
(2.5 to 3.3)
3.40
(3.0 to 3.8)
3.12
(2.7 to 3.5)
2.96
(2.6 to 3.4)
3.37
(3.0 to 3.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, DPH 50mg
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]
14.Secondary Outcome
Title Overall Rating of Severity in Categorical Pain Rating Scale Score
Hide Description Subject responded to question, 'My pain at this time is' by selecting one of the following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3).
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 2.44  (0.51) 2.48  (0.51) 2.48  (0.51) 2.48  (0.51) 2.37  (0.49) 2.22  (0.42)
Post-Baseline 1.26  (1.02) 1.48  (1.05) 1.26  (0.94) 1.78  (0.97) 2.67  (0.62) 1.41  (1.01)
15.Secondary Outcome
Title Change From Baseline in Categorical Pain Rating Scale Score
Hide Description Subjects responded to question, 'My pain at this time is' with following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Subjects completed this question at baseline (post-dental surgery) and after sleep period. The following measure is the change in pain rating from baseline.
Time Frame Baseline and up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-1.2
(-1.5 to -0.8)
-1.0
(-1.3 to -0.6)
-1.2
(-1.5 to -0.8)
-0.7
(-1.0 to -0.3)
0.3
(-0.1 to 0.6)
-0.9
(-1.3 to -0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
16.Secondary Outcome
Title Overall Rating of Severity in Visual Analog Scale (VAS) Score
Hide Description Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.
Time Frame At 10 hours
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ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 76.11  (11.6) 77.26  (13.1) 78.19  (13.4) 73.70  (12.3) 79.15  (9.76) 73.11  (10.5)
Post-Baseline 32.11  (31.1) 40.30  (33.0) 30.33  (28.6) 48.59  (33.4) 84.26  (19.9) 38.19  (32.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Visual Analog Scale (VAS) Score
Hide Description Subjects completed the VAS scale at baseline (post-dental surgery) and after completion of the sleep period. Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.This measure indicates the change in pain severity rating on the VAS scale from baseline.
Time Frame Baseline and up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-44.04
(-55.1 to -33.0)
-36.65
(-47.7 to -25.6)
-47.26
(-58.4 to -36.2)
-25.89
(-37.0 to -14.8)
6.00
(-5.1 to 17.1)
-35.89
(-47.0 to -24.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
18.Secondary Outcome
Title Overall Rating of Pain Relief
Hide Description Subjects responded to question, "Overall, the relief from my starting pain was" by checking one of the following choices: no relief (0), a little relief (1), some relief (2), a lot of relief (3), complete relief (4).
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Measure Type: Number
Unit of Measure: Participants
No relief 1 3 2 6 11 4
A little relief 4 4 3 3 9 2
Some relief 8 7 5 4 5 5
A lot relief 12 10 13 11 2 13
Complete relief 2 3 4 3 0 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
19.Secondary Outcome
Title Time to Rescue Medication
Hide Description Subjects were allowed to "rescue" and take a non-study pain reliever if the pain was not tolerable. This measure represents for the time to taking rescue medication from the time the subject took study treatment.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Median (95% Confidence Interval)
Unit of Measure: Minutes
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[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 (BAYH6689) / DPH 50mg, DPH 50mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
20.Secondary Outcome
Title Cumulative Proportion of Participants Taking Rescue Medication by Hour
Hide Description Subjects were allowed to "rescue" and take a non-study pain reliever if the pain was not tolerable. This measure represents for the proportion of subjects who rescued in the study.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Measure Type: Number
Unit of Measure: Participants
1 hour 2 3 0 1 4 0
2 hours 6 9 5 9 17 7
3 hours 8 11 5 9 20 7
4 hours 10 11 5 10 21 7
5 hours 11 11 5 11 24 7
6 hours 11 11 6 12 25 9
7 hours 11 12 7 13 25 10
8 hours 11 12 7 13 25 10
9 hours 11 12 8 13 25 11
10 hours 12 12 8 13 25 11
21.Secondary Outcome
Title Global Assessment of Study Medication as a Pain Reliever
Hide Description Subject responded to question, 'How would you rating this study medication you received as a pain-reliever?' with the following choices: Poor (0), Fair(1), Good(2), Very Good(3), Excellent(4)
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Measure Type: Number
Unit of Measure: Participants
Poor 1 4 2 6 15 5
Fair 6 7 5 4 7 5
Good 7 7 4 7 5 4
Very good 11 4 9 9 0 11
Excellent 2 5 7 1 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
22.Secondary Outcome
Title Number of Times Participants Took Rescue Medication
Hide Description Subjects were allowed to "rescue" and take a non-study pain reliever if the pain was not tolerable. This measure represents for the number of times rescue medication was taken by a subject.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Measure Type: Number
Unit of Measure: Participants
0 15 15 19 14 2 16
1 12 12 8 13 22 11
2 0 0 0 0 3 0
3 0 0 0 0 0 0
23.Secondary Outcome
Title Total Wake Time Measured by Actigraphy
Hide Description 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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Minutes
253.72
(174 to 333)
290.03
(210 to 370)
180.21
(100 to 260)
285.62
(206 to 365)
518.58
(439 to 598)
255.20
(175 to 336)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
24.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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage of sleep time
57.24
(44 to 71)
51.49
(38 to 65)
68.87
(55 to 82)
52.09
(39 to 66)
12.85
(-1 to 26)
56.70
(43 to 70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
25.Secondary Outcome
Title Activity Mean Measured by Actigraphy
Hide Description Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Activity mean - average movement per minute.
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent to Treat) Population
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Movement per minute
42.09
(25 to 59)
48.48
(32 to 65)
26.73
(10 to 43)
52.36
(36 to 69)
72.43
(56 to 89)
41.14
(24 to 58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
26.Secondary Outcome
Title Wake Episode Measured by Actigraphy
Hide Description Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Wake Episodes - # of blocks of continuous wake epochs (defined as 2 or more consecutive epochs scored as wake that ends when there is at least one epoch scored as sleep subsequent to the start of the wake epochs).
Time Frame Up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description:
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
Overall Number of Participants Analyzed 27 27 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Wake episodes
8.38
(5 to 11)
10.86
(8 to 14)
13.26
(10 to 16)
9.89
(7 to 13)
5.84
(3 to 9)
11.98
(9 to 15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Treatment emergent adverse events (TEAEs) were collected after the administration of the first dose of study drug up to 5 days post drug administration, or up to 30 days after the last study drug administration if they were serious adverse events (SAEs).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Hide Arm/Group Description Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally. Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally. Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
All-Cause Mortality
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Affected / at Risk (%) Affected / at Risk (%) 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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/27 (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 (BAYH6689) / DPH 50mg Naproxen Sodium 440 mg (BAYH6689) Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Naproxen Sodium 220 mg (BAYH6689) DPH 50mg Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/27 (7.41%)   2/27 (7.41%)   3/27 (11.11%)   1/27 (3.70%)   5/27 (18.52%)   1/27 (3.70%) 
Gastrointestinal disorders             
ABDOMINAL PAIN * 1  0/27 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%) 
CONSTIPATION * 1  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/27 (0.00%) 
NAUSEA * 1  1/27 (3.70%)  1/27 (3.70%)  2/27 (7.41%)  0/27 (0.00%)  2/27 (7.41%)  0/27 (0.00%) 
VOMITING * 1  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  2/27 (7.41%)  0/27 (0.00%) 
General disorders             
PYREXIA * 1  0/27 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%) 
Nervous system disorders             
DIZZINESS * 1  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/27 (0.00%) 
HEADACHE * 1  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/27 (0.00%) 
RESTLESS LEGS SYNDROME * 1  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/27 (0.00%) 
Psychiatric disorders             
INSOMNIA * 1  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/27 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
PHARYNGOLARYNGEAL PAIN * 1  0/27 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%) 
Skin and subcutaneous tissue disorders             
PRURITUS * 1  1/27 (3.70%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/27 (3.70%) 
URTICARIA * 1  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/27 (3.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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: NCT01118273     History of Changes
Other Study ID Numbers: 13053
First Submitted: April 15, 2010
First Posted: May 6, 2010
Results First Submitted: January 24, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 8, 2015