Clinical Trial Results:
A Pilot Self Selection Trial of an Extended-Release Over-the-Counter Analgesic
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Summary
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EudraCT number |
2014-005305-20 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
29 Aug 2011
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Results information
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Results version number |
v2(current) |
This version publication date |
07 Sep 2016
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First version publication date |
04 Jul 2015
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BAYH6689/15833
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01383486 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Bayer AG
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Sponsor organisation address |
Kaiser-Wilhelm-Allee, D-51368, Leverkusen, Germany,
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Public contact |
Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
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Scientific contact |
Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Aug 2011
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Aug 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering
the study, the informed consent form was read by and explained to all subjects and/or their legally authorized representatives. Participating subjects and/or their legally authorized representatives signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Jul 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 246
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Worldwide total number of subjects |
246
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
2
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Adults (18-64 years) |
205
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From 65 to 84 years |
38
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85 years and over |
1
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Recruitment
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Recruitment details |
The trial was conducted at 10 pharmacies across the United States between 05 July 2011 (first subject first visit) and 29 August 2011 (last subject last visit). Of 435 subjects screened, 384 were qualified for participation, 259 presented at pharmacy to begin enrollment procedures, 254 gave informed consent and 1 refused to give pregnancy test. | ||||||
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Pre-assignment
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Screening details |
Of 253 subjects provided with the study drugs, 18 subjects did not receive any study drug due to incomplete information for analysis in 2 subjects, 6 subjects did not take any product and 10 subjects were lost to follow up. Overall, 237 subjects were treated out of which 235 subjects gave estimated pain duration. | ||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Naproxen Sodium ER (BAY H6689) or Advil IR | ||||||
Arm description |
Eligible subjects were treated with 24 Advil immediate release (IR) caplets containing 200 milligram (mg) ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg naproxen sodium. Upon single incidence of pain, subjects were instructed to review both the packages and choose one product to use. Subjects were not offered any additional instructions for use beyond what was on the packages. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Ibuprofen
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Investigational medicinal product code |
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Other name |
Advil
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Eligible subjects were treated with 24 Advil IR caplets containing 200 mg ibuprofen orally.
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Investigational medicinal product name |
Naproxen sodium
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Investigational medicinal product code |
BAYH6689
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Other name |
Aleve 24 Hour
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Eligible subjects were treated with 20 Aleve 24 Hour ER tablets containing 660 mg naproxen sodium orally.
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Not all enrolled subjects were treated with study drugs and gave estimated duration of pain. As baseline included only treated subjects who gave estimated duration of pain, the worldwide number enrolled in the trial differs with the number of subjects reported in the baseline period. |
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Baseline characteristics reporting groups
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Reporting group title |
Naproxen Sodium ER (BAY H6689) or Advil IR
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Reporting group description |
Eligible subjects were treated with 24 Advil immediate release (IR) caplets containing 200 milligram (mg) ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg naproxen sodium. Upon single incidence of pain, subjects were instructed to review both the packages and choose one product to use. Subjects were not offered any additional instructions for use beyond what was on the packages. | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Naproxen Sodium ER (BAY H6689) or Advil IR
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Reporting group description |
Eligible subjects were treated with 24 Advil immediate release (IR) caplets containing 200 milligram (mg) ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg naproxen sodium. Upon single incidence of pain, subjects were instructed to review both the packages and choose one product to use. Subjects were not offered any additional instructions for use beyond what was on the packages. | ||
Subject analysis set title |
Selection evaluation population
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Selection evaluation population (N=235) included subjects who took any study medication and gave estimated duration of pain.
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End point title |
The Percentage of Subjects Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours [1] | ||||||||
End point description |
Subjects were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Subjects who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of subjects who selected naproxen sodium ER and reported expected duration of pain less than or equal to 12 hours (A); 2) number of subjects who selected naproxen sodium ER and report expected duration of pain greater than 12 hours (B). The result was calculated as B/(A+B).
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End point type |
Primary
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End point timeframe |
Up to 14 days
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [2] - Only subjects who chose naproxen sodium were included in the analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
The Percentage of Subjects Who Selected Naproxen Sodium ER, Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within 24 hours of their selection decision taken up to 14 days
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| Notes [3] - Subgroup of selection evaluation population. |
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| No statistical analyses for this end point | |||||||||
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End point title |
The Percentage of Low Literacy Subjects Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours | ||||||||
End point description |
In addition to the primary endpoint evaluated for all selection evaluable subjects, this secondary endpoint was evaluated separately for low literacy subjects. Low literacy subjects were defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score less than or equal to 60 at visit 1.
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End point type |
Secondary
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End point timeframe |
Up to 14 days
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| Notes [4] - Subgroup of selection evaluation population: low literacy subjects who chose naproxen sodium. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Subjects were followed for adverse events from the date of informed consent signed until the use of the product and follow up use phone call, or until the end of follow-up period (approximately 14 days)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.1
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Reporting groups
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Reporting group title |
Naproxen Sodium ER (BAYH6689) or Advil IR)
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Reporting group description |
Eligible subjects were treated with 24 Advil IR caplets containing 200 mg ibuprofen and 20 Aleve 24Hour ER tablets containing 660 mg naproxen sodium. Upon single incidence of pain, subjects wereinstructed to review both the packages and choose one product to use. Subjects were not offered anyadditional instructions for use beyond what was on the packages. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 May 2011 |
In the original protocol, subjects were to only receive one pill of each product. However, since Advil is commercially available in a 24-count box, it was
determined that providing a commercial product in the commercial packaging would be more naturalistic. To maintain consistency between the two products, a 20-count Aleve 24 Hour bottle in a proposed commercial outer carton was provided as well. The protocol was amended to change the amount of both the Aleve 24 Hour and Advil that was provided to subjects during the treatment period of the clinical trial. |
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28 Jun 2011 |
The protocol was amended to (1) clarify screening procedures, (2) clarify analysis of the primary endpoint, and (3) to add questions to the interview questions for the enrollment period and End of Trial follow up period. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Since this study was a self-selection study made by consumer, 7 out of 253 enrolled subjects did not report their age as providing their age was optional. Hence, subjects enrolled per country and age was provided for 246 subjects. | |||
