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Safety Trial of Naproxen Sodium/ Diphenhydramine (MUST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01365052
First received: May 17, 2011
Last updated: May 13, 2015
Last verified: May 2015
Results First Received: January 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator)
Condition: Pain
Interventions: Drug: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
Drug: Placebo

  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) 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
Placebo 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days

Participant Flow:   Overall Study
    Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)   Placebo
STARTED   217   109 
COMPLETED   213   105 
NOT COMPLETED   4   4 
Adverse Event                4                4 



  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) 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
Placebo 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
Total Total of all reporting groups

Baseline Measures
   Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 217   109   326 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.9  (18.14)   47.1  (19.26)   47.0  (18.49) 
Age, Customized [1] 
[Units: Participants]
     
<60 years   152   72   224 
Greater than or equal to 60 years   65   37   102 
>65 years   46   28   74 
[1] Some categories will have overlapping samples
Gender 
[Units: Participants]
     
Female   133   65   198 
Male   84   44   128 


  Outcome Measures
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1.  Primary:   Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product   [ Time Frame: 10 days after randomization ]

2.  Primary:   Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product   [ Time Frame: 10 days after randomization ]

3.  Other Pre-specified:   Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product   [ Time Frame: 10 days after randomization ]

4.  Other Pre-specified:   Treatment Compliance - Number of Capsules Taken   [ Time Frame: 10 days after randomization ]

5.  Other Pre-specified:   Treatment Compliance - Duration of Exposure to Treatment in Days   [ Time Frame: 10 days after randomization ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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



Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01365052     History of Changes
Other Study ID Numbers: 15560
Study First Received: May 17, 2011
Results First Received: January 24, 2014
Last Updated: May 13, 2015
Health Authority: United States: Food and Drug Administration