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Actual Use Trial of Naproxen Sodium (Kiefer AUT)

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ClinicalTrials.gov Identifier: NCT01427803
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : May 20, 2013
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: Naproxen Sodium ER (BAYH6689)
Enrollment 778
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patterns of Use Cohort Reasons for Misuse Cohort
Hide Arm/Group Description A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use. A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
Period Title: Overall Study
Started 526 252
Purchased Product 525 [1] 252
Baseline Assessment 516 130 [2]
Took Product 508 [3] 237 [4]
Completed 463 226 [5]
Not Completed 63 26
Reason Not Completed
Lost to Follow-up             32             26
Withdrawal by Subject             20             0
Unable to complete full treatment period             6             0
Protocol Violation             1             0
Physician Decision             3             0
did not take product             1             0
[1]
Only 516 participants used e-diary
[2]
only interviewed participants were assessed
[3]
Those who took at least one dose of investigational product. Only 502 qualified for data analysis.
[4]
Those who took at least one dose of investigational product as logged in e diary & 1 on Health Log.
[5]
130 participants interviewed. Remaining subjects continued in trial to collect safety information.
Arm/Group Title Patterns of Use User Population Reasons for Misuse Interviewed Population Total
Hide Arm/Group Description A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use. A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions. Total of all reporting groups
Overall Number of Baseline Participants 516 130 646
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 516 participants 130 participants 646 participants
12 to 17 Years 3 0 3
18 to 24 Years 25 4 29
25 to 34 Years 63 13 76
35 to 44 Years 81 28 109
45 to 54 Years 142 30 172
55 Years or Older 202 55 257
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 516 participants 130 participants 646 participants
Female
295
  57.2%
68
  52.3%
363
  56.2%
Male
221
  42.8%
62
  47.7%
283
  43.8%
1.Primary Outcome
Title Estimated Percentage of Misuse for Non-Therapeutic Reasons
Hide Description The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Patterns of Use cohort who took the product + Participants in Reason for Misuse cohort who completed interview
Arm/Group Title Naproxen Sodium ER (BAYH6689)
Hide Arm/Group Description:
Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
Overall Number of Participants Analyzed 632
Measure Type: Number
Unit of Measure: Percentage of Participants
6.5
2.Secondary Outcome
Title Non-therapeutic Reasons for Misuse
Hide Description Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Reason for Misuse cohort who misused the product due to non-therapeutic reasons were included in this analysis
Arm/Group Title Naproxen Sodium ER (BAYH6689)
Hide Arm/Group Description:
Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: Participants
52
3.Secondary Outcome
Title Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course
Hide Description This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by "use day". A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive "evaluable days."
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Patterns of Use cohort who took the product + Reasons for misuse interviewed population
Arm/Group Title Naproxen Sodium ER (BAYH6689)
Hide Arm/Group Description:
Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
Overall Number of Participants Analyzed 632
Measure Type: Number
Unit of Measure: Percentage of participants
5
4.Secondary Outcome
Title Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days
Hide Description Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Patterns of Use User Population who had at least 10 use days of the product
Arm/Group Title Naproxen Sodium ER (BAYH6689)
Hide Arm/Group Description:
Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
Overall Number of Participants Analyzed 375
Measure Type: Number
Unit of Measure: Percentage of participants
14.9
5.Secondary Outcome
Title Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day
Hide Description Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Patterns of Use User Population who had at least 10 use days of the product
Arm/Group Title Naproxen Sodium ER (BAYH6689)
Hide Arm/Group Description:
Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
Overall Number of Participants Analyzed 375
Measure Type: Number
Unit of Measure: Percentage of participants
4.8
6.Secondary Outcome
Title Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken
Hide Description Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Patterns of Use cohort who took the product
Arm/Group Title Naproxen Sodium ER (BAYH6689)
Hide Arm/Group Description:
Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
Overall Number of Participants Analyzed 502
Measure Type: Number
Unit of Measure: Percentage of participants
19.7
7.Secondary Outcome
Title Percentage of Dosing Occasions Where More Than One Tablet Was Taken
Hide Description Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Patterns of Use cohort who took the product
Arm/Group Title Naproxen Sodium ER (BAYH6689)
Hide Arm/Group Description:
Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
Overall Number of Participants Analyzed 502
Overall Number of Units Analyzed
Type of Units Analyzed: Dosing occasions
 9895
Measure Type: Number
Unit of Measure: Percentage of dosing occasions
5.4
8.Secondary Outcome
Title Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
Hide Description Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Patterns of Use cohort who took the product
Arm/Group Title Naproxen Sodium ER (BAYH6689)
Hide Arm/Group Description:
Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
Overall Number of Participants Analyzed 502
Measure Type: Number
Unit of Measure: Percentage of participants
72.5
9.Secondary Outcome
Title Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
Hide Description Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Patterns of Use cohort who took the product
Arm/Group Title Naproxen Sodium ER (BAYH6689)
Hide Arm/Group Description:
Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
Overall Number of Participants Analyzed 502
Overall Number of Units Analyzed
Type of Units Analyzed: Dosing occasions
 9895
Measure Type: Number
Unit of Measure: Percentage of dosing occasions
27.8
Time Frame 28 days
Adverse Event Reporting Description AEs were collected at the Follow-up telephone interview after completion of the 28 day Use Phase or sooner if they discontinued from the study. The safety population consisted of all participants who took product. Safety data from the two cohorts were pooled in one group as both cohorts received the same treatment.
 
Arm/Group Title Naproxen Sodium ER (BAYH6689)
Hide Arm/Group Description Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
All-Cause Mortality
Naproxen Sodium ER (BAYH6689)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Naproxen Sodium ER (BAYH6689)
Affected / at Risk (%) # Events
Total   6/745 (0.81%)    
Cardiac disorders   
cardiac failure congestive * 1  1/745 (0.13%)  1
Gastrointestinal disorders   
diarrhea haemorrhagic * 1  1/745 (0.13%)  1
Hepatobiliary disorders   
gallbladder disorder * 1  1/745 (0.13%)  1
Immune system disorders   
hypersensitivity * 1  1/745 (0.13%)  1
Infections and infestations   
viral infection * 1  1/745 (0.13%)  1
Injury, poisoning and procedural complications   
overdose * 1  1/745 (0.13%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Naproxen Sodium ER (BAYH6689)
Affected / at Risk (%) # Events
Total   89/745 (11.95%)    
Gastrointestinal disorders   
abdominal pain upper * 1  14/745 (1.88%)  15
constipation * 1  12/745 (1.61%)  12
diarrhoea * 1  11/745 (1.48%)  11
Infections and infestations   
nasopharyngitis * 1  20/745 (2.68%)  20
sinusitis * 1  10/745 (1.34%)  10
Musculoskeletal and connective tissue disorders   
back pain * 1  8/745 (1.07%)  8
Nervous system disorders   
headache * 1  14/745 (1.88%)  15
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head Medical Affairs
Organization: Bayer HealthCare LLC, Consumer Care
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01427803    
Other Study ID Numbers: 15647
First Submitted: August 31, 2011
First Posted: September 2, 2011
Results First Submitted: February 5, 2013
Results First Posted: May 20, 2013
Last Update Posted: October 15, 2015