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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01280591
First received: January 20, 2011
Last updated: May 16, 2014
Last verified: May 2014
Results First Received: January 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Pain, Postoperative
Interventions: Drug: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)
Drug: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)
Drug: Naproxen sodium 440 mg (BAYH6689)
Drug: DPH 50 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Naproxen Sodium 440 mg (BAYH6689) Participants received two Naproxen sodium 220 mg tablets orally, single dose
DPH 50 mg Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Participant Flow:   Overall Study
    Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)     Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)     Naproxen Sodium 440 mg (BAYH6689)     DPH 50 mg  
STARTED     203     204     203     102  
COMPLETED     203     204     203     99  
NOT COMPLETED     0     0     0     3  
Withdrawal by Subject                 0                 0                 0                 2  
Does not meet exclusion #27 criteria                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Naproxen Sodium 440 mg (BAYH6689) Participants received two Naproxen sodium 220 mg tablets orally, single dose
DPH 50 mg Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
Total Total of all reporting groups

Baseline Measures
    Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)     Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)     Naproxen Sodium 440 mg (BAYH6689)     DPH 50 mg     Total  
Number of Participants  
[units: participants]
  203     204     203     102     712  
Age  
[units: Years]
Mean ± Standard Deviation
  21.4  ± 4.87     21.0  ± 4.25     21.0  ± 4.50     21.5  ± 5.59     21.2  ± 4.70  
Gender  
[units: Participants]
         
Female     108     124     117     54     403  
Male     95     80     86     48     309  
Baseline Categorical Pain Rating Scale  
[units: Participants]
         
No pain     0     0     0     0     0  
Mild pain     0     0     0     0     0  
Moderate pain     146     134     140     74     494  
Severe pain     57     70     63     28     218  



  Outcome Measures
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1.  Primary:   Wake Time After Sleep Onset (WASO) Measured by Actigraphy   [ Time Frame: Up to 10 hours ]

2.  Primary:   Sleep Latency Measured by Actigraphy   [ Time Frame: Up to 10 hours ]

3.  Secondary:   Total Sleep Time Measured by Actigraphy   [ Time Frame: Up to 10 hours ]

4.  Secondary:   Sleep Efficiency Measured by Actigraphy   [ Time Frame: Up to 10 hours ]

5.  Secondary:   Global Assessment of Investigational Product as a Sleep Aid   [ Time Frame: Up to 10 hours ]

6.  Secondary:   Karolinska Sleep Diary - Sleep Quality   [ Time Frame: Up to 10 hours ]

7.  Secondary:   Karolinska Sleep Diary - Calmness of Sleep   [ Time Frame: Up to 10 hours ]

8.  Secondary:   Karolinska Sleep Diary - Easiness to Fall Asleep   [ Time Frame: Up to 10 hours ]

9.  Secondary:   Karolinska Sleep Diary - Premature Awakening   [ Time Frame: Up to 10 hours ]

10.  Secondary:   Karolinska Sleep Diary - Ease of Awakening   [ Time Frame: Up to 10 hours ]

11.  Secondary:   Karolinska Sleep Diary - Well Rested   [ Time Frame: Up to 10 hours ]

12.  Secondary:   Karolinska Sleep Diary - Sufficient Sleep   [ Time Frame: Up to 10 hours ]

13.  Secondary:   Subjective Sleep Questionnaire - Quality of Your Sleep Last Night   [ Time Frame: Up to 10 hours ]

14.  Secondary:   Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night   [ Time Frame: Up to 10 hours ]

15.  Secondary:   Subjective Sleep Questionnaire - Time to Fall Asleep Last Night   [ Time Frame: Up to 10 hours ]

16.  Secondary:   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   [ Time Frame: Up to 10 hours ]

17.  Secondary:   Change From Baseline in Pain Intensity   [ Time Frame: Baseline and up to 10 hours ]

18.  Secondary:   Overall Rating of Pain Relief   [ Time Frame: Up to 10 hours ]

19.  Secondary:   Time to Rescue Medication   [ Time Frame: Up to 10 hours ]

20.  Secondary:   Cumulative Proportion of Subjects Taking Rescue Medication by Hour   [ Time Frame: Up to 10 hours ]

21.  Secondary:   Global Assessment of Investigational Product as a Pain Reliever   [ Time Frame: Up to 10 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01280591     History of Changes
Other Study ID Numbers: 14837
Study First Received: January 20, 2011
Results First Received: January 24, 2014
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration