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Trial record 43 of 448 for:    diphenhydramine

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

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ClinicalTrials.gov Identifier: NCT01495858
Recruitment Status : Completed
First Posted : December 20, 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 25 mg (BAY98-7111)
Drug: Naproxen Sodium 440 mg (BAYH6689)
Drug: DPH 50 mg
Enrollment 267
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally. Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally. Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Period Title: Overall Study
Started 107 106 54
Completed 107 106 54
Not Completed 0 0 0
Arm/Group Title Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg Total
Hide Arm/Group Description Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally. Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally. Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. Total of all reporting groups
Overall Number of Baseline Participants 107 106 54 267
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 106 participants 54 participants 267 participants
21.4  (5.55) 21.3  (5.27) 20.8  (4.64) 21.2  (5.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 106 participants 54 participants 267 participants
Female
72
  67.3%
64
  60.4%
37
  68.5%
173
  64.8%
Male
35
  32.7%
42
  39.6%
17
  31.5%
94
  35.2%
Baseline Categorical Pain Rating Scale  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 106 participants 54 participants 267 participants
No pain 0 0 0 0
Mild pain 0 0 0 0
Moderate pain 69 63 28 160
Severe pain 38 43 26 107
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Minutes
155.25
(121.57 to 188.93)
180.08
(146.36 to 213.80)
364.83
(317.52 to 412.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.3047
Comments [Not Specified]
Method ANCOVA
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Median (95% Confidence Interval)
Unit of Measure: Minutes
23.50
(18.00 to 28.00)
16.75
(13.50 to 25.00)
27.50
(16.00 to 36.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.1677
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Total Sleep Time Measured by Actigraphy
Hide Description 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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Minutes
418.66
(385.05 to 452.28)
392.38
(358.72 to 426.03)
206.61
(159.39 to 253.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.2764
Comments [Not Specified]
Method ANCOVA
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent of sleep time during in-bed time
69.777
(64.175 to 75.380)
65.396
(59.787 to 71.006)
34.436
(26.566 to 42.306)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.2764
Comments [Not Specified]
Method ANCOVA
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 85 79 19
Measure Type: Number
Unit of Measure: Participants
0 = Poor 2 13 1
1 = Fair 12 24 7
2 = Good 37 24 2
3 = Very good 23 13 8
4 = Excellent 11 5 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 102 44
Measure Type: Number
Unit of Measure: Participants
1 = Very poor 1 3 9
2 = Rather poor 12 22 11
3 = Neither poor nor good 33 31 9
4 = Rather good 47 36 12
5 = Very good 9 10 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.0004
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 102 44
Measure Type: Number
Unit of Measure: Participants
1 = Very restless 1 3 5
2 = Rather restless 26 29 17
3 = Neither restless nor calm 18 24 5
4 = Rather calm 48 42 13
5 = Very calm 9 4 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.0145
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 102 44
Measure Type: Number
Unit of Measure: Participants
1 = Very difficult 3 8 9
2 = Rather difficult 29 33 6
3 = Neither difficult nor easy 22 27 14
4 = Rather easy 36 23 12
5 = Very easy 12 11 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 >0.05
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 102 44
Measure Type: Number
Unit of Measure: Participants
1 = Woke up much too early 24 31 21
2 = Woke up somewhat too early 45 52 11
3 = No 33 19 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.0387
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 102 44
Measure Type: Number
Unit of Measure: Participants
1 = Very difficult 0 3 0
2 = Rather difficult 1 0 2
3 = Neither difficult nor easy 17 16 5
4 = Rather easy 56 53 14
5 = Very easy 28 30 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.0305
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 102 44
Measure Type: Number
Unit of Measure: Participants
1 = Not rested at all 7 9 13
2 = Somewhat unrested 53 55 17
3 = Completely rested 42 38 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.0176
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 102 44
Measure Type: Number
Unit of Measure: Participants
1 = No, definitely too little 2 10 13
2 = No, much too little 8 10 6
3 = No, somewhat too little 18 27 8
4 = Yes, almost enough 52 34 11
5 = Yes, definitely enough 22 21 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 Cochran-Mantel-Haenszel
Comments [Not Specified]
13.Secondary Outcome
Title Subjective Sleep Questionnaire - Quality of Your Sleep Last Night
Hide Description Subject evaluated sleep quality on a 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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 101 44
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
6.5  (1.95) 5.8  (2.11) 4.9  (3.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.0036
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 101 44
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
6.6  (2.15) 5.7  (2.20) 4.6  (2.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 101 44
Mean (Standard Deviation)
Unit of Measure: Minutes
39.5  (36.63) 40.2  (38.10) 40.0  (42.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 >0.05
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 102 101 44
Mean (Standard Deviation)
Unit of Measure: Minutes
111.1  (121.86) 144.8  (125.58) 98.4  (89.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 >0.05
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.4  (0.48) 2.4  (0.49) 2.5  (0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.4519
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
Arm/Group Title Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Measure Type: Number
Unit of Measure: Participants
0 = No relief 24 30 35
1 = A little relief 5 3 4
2 = Some relief 10 15 5
3 = A lot of relief 47 37 8
4 = Complete relief 21 21 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.3707
Comments [Not Specified]
Method ANCOVA
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Median (95% Confidence Interval)
Unit of Measure: Minutes
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
146.50
(118.00 to 314.00)
[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 25 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 Log Rank
Comments [Not Specified]
20.Secondary Outcome
Title Cumulative Proportion of Participants 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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Measure Type: Number
Unit of Measure: participants
≤ 60 minutes 0 1 0
≤ 120 minutes 9 12 21
≤ 180 minutes 14 13 29
≤ 240 minutes 15 17 32
≤ 300 minutes 16 23 33
≤ 360 minutes 17 25 34
≤ 420 minutes 21 26 35
≤ 480 minutes 22 28 35
≤ 540 minutes 24 30 35
≤ 600 minutes 24 30 35
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 85 79 19
Measure Type: Number
Unit of Measure: Participants
0 = Poor 1 1 1
1 = Fair 4 3 5
2 = Good 22 25 3
3 = Very good 40 38 9
4 = Excellent 18 12 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Sodium 440 mg / DPH 25 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 0.3765
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
22.Other Pre-specified Outcome
Title Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2
Hide Description [Not Specified]
Time Frame Baseline and day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.3  (12.65) -0.6  (13.51) 2.2  (11.77)
23.Other Pre-specified Outcome
Title Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2
Hide Description [Not Specified]
Time Frame Baseline and Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Mean (Standard Deviation)
Unit of Measure: mmHg
0.7  (10.58) -0.2  (8.42) 2.1  (8.83)
24.Other Pre-specified Outcome
Title Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2
Hide Description [Not Specified]
Time Frame Baseline and day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Mean (Standard Deviation)
Unit of Measure: Beats/min
1.0  (10.57) -0.1  (11.94) 4.7  (12.65)
25.Other Pre-specified Outcome
Title Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2
Hide Description [Not Specified]
Time Frame Baseline and day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description:
Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Overall Number of Participants Analyzed 107 106 54
Mean (Standard Deviation)
Unit of Measure: Breaths/min
-1.4  (3.12) -1.2  (2.97) -0.3  (2.70)
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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Hide Arm/Group Description Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
All-Cause Mortality
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   0/106 (0.00%)   0/54 (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 25 mg (BAY98-7111) Naproxen Sodium 440 mg (BAYH6689) DPH 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/107 (19.63%)   14/106 (13.21%)   17/54 (31.48%) 
Ear and labyrinth disorders       
Deafness * 1  1/107 (0.93%)  0/106 (0.00%)  0/54 (0.00%) 
Tinnitus * 1  0/107 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Eye disorders       
Vision blurred * 1  1/107 (0.93%)  0/106 (0.00%)  1/54 (1.85%) 
Gastrointestinal disorders       
Nausea * 1  6/107 (5.61%)  4/106 (3.77%)  2/54 (3.70%) 
Vomiting * 1  1/107 (0.93%)  0/106 (0.00%)  1/54 (1.85%) 
Hypoaesthesia oral * 1  0/107 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
General disorders       
Chest discomfort * 1  1/107 (0.93%)  0/106 (0.00%)  0/54 (0.00%) 
Feeling hot * 1  0/107 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Feeling jittery * 1  0/107 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Injury, poisoning and procedural complications       
Post procedural haemorrhage * 1  0/107 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Procedural complication * 1  0/107 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Investigations       
Blood pressure increased * 1  0/107 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Cardiac murmur * 1  1/107 (0.93%)  0/106 (0.00%)  0/54 (0.00%) 
Nervous system disorders       
Dizziness * 1  9/107 (8.41%)  9/106 (8.49%)  2/54 (3.70%) 
Headache * 1  6/107 (5.61%)  3/106 (2.83%)  10/54 (18.52%) 
Hypoaesthesia * 1  1/107 (0.93%)  0/106 (0.00%)  0/54 (0.00%) 
Syncope * 1  0/107 (0.00%)  1/106 (0.94%)  0/54 (0.00%) 
Renal and urinary disorders       
Pollakiuria * 1  0/107 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders       
Nasal congestion * 1  1/107 (0.93%)  0/106 (0.00%)  0/54 (0.00%) 
Oropharyngeal pain * 1  1/107 (0.93%)  0/106 (0.00%)  0/54 (0.00%) 
Skin and subcutaneous tissue disorders       
Cold sweat * 1  3/107 (2.80%)  0/106 (0.00%)  1/54 (1.85%) 
Hyperhidrosis * 1  1/107 (0.93%)  0/106 (0.00%)  0/54 (0.00%) 
Pruritus * 1  1/107 (0.93%)  0/106 (0.00%)  0/54 (0.00%) 
Vascular disorders       
Flushing * 1  0/107 (0.00%)  0/106 (0.00%)  1/54 (1.85%) 
*
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: NCT01495858     History of Changes
Other Study ID Numbers: 15881
First Submitted: December 16, 2011
First Posted: December 20, 2011
Results First Submitted: January 24, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 8, 2015