Clinical trial NCT00751400: Naproxen Sodium Extended-Release Actual Use Study
Official title: An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Non-prescription
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Pegus Research, Inc.
First posted: 2008-09-12
Enrollment: 497
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.

Detailed description: Issues on adverse event data are addressed in the Adverse Event section.

The following acronyms and abbreviations were used in the results section.

- General Educational Development (GED)

Eligibility criteria: Inclusion Criteria:

* Self report use of Over The Counter (OTC) analgesics
* Able to read and understand English
* Provide written informed consent (subjects 12- 17 years of age provide written as sent and/ or parent or legal guardian provide written consent)
* Purchase the investigational product

Exclusion Criteria:

* Have participated in a study involving OTC analgesics in the last 12 months
* They or someone else in the household work for a market research company, an advertising agency, a public relations firm, pharmaceutical company, as a healthcare professional, or as part of a health care practice
* Have a history of known allergies to nonsteroidal anti-inflammatory drugs (NSAIDs) (i.e., Naproxen, Ibuprofen, etc) or Aspirin
* Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days
* (Female subjects) are pregnant or breastfeeding

Primary outcomes:
measure: Use Days With One or More Misuse Occasions
timeFrame: 1 month
Secondary outcomes:
measure: Dosing Occasions With One and More Than One Tablet Taken
timeFrame: 1 month
measure: Use Days With and Without Next Dose Less Than 22 Hours Later
timeFrame: 1 month
measure: Number of Subjects With and Without More Than One Tablet Taken Per Dose
timeFrame: 1 month
measure: Number of Subjects With and Without Next Dose Less Than 22 Hours Later
timeFrame: 1 month
measure: Number of Subjects With and Without More Than 660 mg at Least Once
timeFrame: 1 month
measure: Average Daily Dose
timeFrame: 1 month
measure: Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days
timeFrame: 1 month
measure: Number of Total Dosing Occasions Per Subject
timeFrame: 1 month
measure: Number of Dosing Occasions Per Subject That Exceeded 660 mg
timeFrame: 1 month
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Oceanside
country: United States
state: California
city: San Dimas
country: United States
state: California
city: Overland Park
country: United States
state: Kansas
city: Anoka
country: United States
state: Minnesota
city: Blaine
country: United States
state: Minnesota
city: Elk River
country: United States
state: Minnesota
city: St. Francis
country: United States
state: Minnesota
city: St. Louis Park
country: United States
state: Minnesota
city: Belton
country: United States
state: Missouri
city: Savannah
country: United States
state: Missouri
city: St. Joseph
country: United States
state: Missouri
city: Cary
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Bountiful
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Syracuse
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Kenmore
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Snohomish
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: