Trial Outcomes & Findings for Self Selection Trial of Naproxen Sodium (NCT NCT01383486)

Last Updated: 2015-10-15

Results Overview

Participants 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. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

253 participants

Primary outcome timeframe

up to 14 days

Results posted on

2015-10-15

Participant Flow

435 subjects were screened, 384 were qualified for participation, 259 subjects presented at pharmacy to begin enrollment procedures, 254 gave inform consent, 1 subject refused to give pregnancy test, so 253 subject received the investigational products.

Participant milestones

Participant milestones
Measure	Naproxen Sodium ER (BAY H6689) or Advil IR Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
Overall Study STARTED	253
Overall Study Treated	237
Overall Study COMPLETED	235
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Naproxen Sodium ER (BAY H6689) or Advil IR Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
Overall Study Lost to Follow-up	10
Overall Study Incomplete information for analysis	2
Overall Study Did not take any product	6

Baseline Characteristics

Self Selection Trial of Naproxen Sodium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naproxen Sodium ER (BAY H6689) or Advil IR n=235 Participants Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
Age, Continuous	51.4 Years STANDARD_DEVIATION 14.3 • n=5 Participants
Gender Female	119 Participants n=5 Participants
Gender Male	115 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 14 days

Population: Only subjects who chose naproxen sodium were included in the analysis.

Outcome measures

Outcome measures
Measure	Naproxen Sodium ER (BAY H6689) or Advil IR n=182 Participants Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours	72.0 Percentage of participants Interval 64.9 to 78.4

SECONDARY outcome

Timeframe: Within 24 hours of their selection decision taken up to 14 days

Population: Subgroup of Selection Evaluation Population

Outcome measures

Outcome measures
Measure	Naproxen Sodium ER (BAY H6689) or Advil IR n=151 Participants Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours	71.5 Percentage of participants Interval 63.6 to 78.6

SECONDARY outcome

Timeframe: Up to 14 days

Population: Subgroup of Selection Evaluation Population: low literacy participants who had REALM score \</= 60 at visit 1 and chose naproxen sodium.

In addition to the primary outcome measure evaluated for all selection evaluable participants, this secondary outcome was evaluated separately for low literacy participants. Low Literacy Participants are defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score \</= 60 at visit 1.

Outcome measures

Outcome measures
Measure	Naproxen Sodium ER (BAY H6689) or Advil IR n=31 Participants Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours	64.5 Percentage of participants Interval 45.4 to 80.8

Adverse Events

Naproxen Sodium ER (BAY H6689) or Advil IR

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Naproxen Sodium ER (BAY H6689) or Advil IR n=237 participants at risk Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
Renal and urinary disorders Nephrolithiasis	0.42% 1/237 • Number of events 1
Musculoskeletal and connective tissue disorders Myalgia	0.42% 1/237 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	0.84% 2/237 • Number of events 2
Gastrointestinal disorders Toothache	0.42% 1/237 • Number of events 1
Nervous system disorders Headache	0.42% 1/237 • Number of events 1
General disorders Pain in extremity	0.42% 1/237 • Number of events 1
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.42% 1/237 • Number of events 1
Nervous system disorders Somnolence	0.42% 1/237 • Number of events 1
Injury, poisoning and procedural complications Contusion	0.42% 1/237 • Number of events 1
Musculoskeletal and connective tissue disorders Arthralgia	0.42% 1/237 • Number of events 1
Infections and infestations Nasopharyngtis	0.42% 1/237 • Number of events 1
Infections and infestations Influenza	0.42% 1/237 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.42% 1/237 • Number of events 1
General disorders Pain	0.42% 1/237 • Number of events 1

Additional Information

Head Clinical and Medical Affairs

Bayer HealthCare LLC, Consumer Care

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60