Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium (VERNE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01389284
First received: July 6, 2011
Last updated: July 28, 2014
Last verified: July 2014
Results First Received: September 14, 2012  
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 ER (BAYH6689)
Drug: Naproxen Sodium IR (Aleve, BAYH6689)
Drug: Naproxen Sodium ER Placebo
Drug: Naproxen Sodium IR 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 ER (BAYH6689) 1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
Naproxen Sodium IR (Aleve, BAYH6689) 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
Placebo 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)

Participant Flow:   Overall Study
    Naproxen Sodium ER (BAYH6689)     Naproxen Sodium IR (Aleve, BAYH6689)     Placebo  
STARTED     120     120     60  
COMPLETED     120     120     60  
NOT COMPLETED     0     0     0  



  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 ER (BAYH6689) 1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
Naproxen Sodium IR (Aleve, BAYH6689) 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
Placebo 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
Total Total of all reporting groups

Baseline Measures
    Naproxen Sodium ER (BAYH6689)     Naproxen Sodium IR (Aleve, BAYH6689)     Placebo     Total  
Number of Participants  
[units: participants]
  120     120     60     300  
Age  
[units: Years]
Mean ± Standard Deviation
  24.0  ± 5.05     23.0  ± 4.67     25.0  ± 6.56     23.8  ± 5.28  
Gender  
[units: Participants]
       
Female     70     71     41     182  
Male     50     49     19     118  
Pain Intensity Score [1]
[units: Participants]
       
0 = None     0     0     0     0  
1 = Mild     0     0     0     0  
2 = Moderate     96     97     53     246  
3 = Severe     24     23     7     54  
[1] Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe



  Outcome Measures
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1.  Primary:   Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)   [ Time Frame: From 0 to 24 hours post-dose ]

2.  Secondary:   Summed, Time-weighted Pain Intensity Differences (SPID)   [ Time Frame: 0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose ]

3.  Secondary:   Summed, Time-weighted Total Pain Relief Scores (TOTPARs)   [ Time Frame: 0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose ]

4.  Secondary:   Pain Intensity Differences (PIDs) by Time From Initial Dose   [ Time Frame: At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose ]

5.  Secondary:   Pain Relief From Initial Dose   [ Time Frame: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose ]

6.  Secondary:   Median Time to First Intake of Rescue Medication   [ Time Frame: Up to 24 hours postdose ]

7.  Secondary:   Cumulative Percentage of Participants Who Took Rescue Medication   [ Time Frame: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose ]

8.  Secondary:   Number of Times the Participants Took Rescue Medication Over the 24-hour Period   [ Time Frame: 24 hours postdose ]

9.  Secondary:   Global Assessment of the Investigational Product as a Pain Reliever   [ Time Frame: 24 hours postdose or immediately before the first intake of rescue medication ]


  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: Head Medical Affairs
Organization: Bayer HealthCare LLC, Consumer Care
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01389284     History of Changes
Other Study ID Numbers: 15142
Study First Received: July 6, 2011
Results First Received: September 14, 2012
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration