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 16, 2014
Last verified: May 2014
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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  
Number of Participants  
[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  
Gender  
[units: Participants]
     
Female     133     65     198  
Male     84     44     128  
[1] Some categories will have overlapping samples



  Outcome Measures
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


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 16, 2014
Health Authority: United States: Food and Drug Administration