Naproxen Sodium Extended-Release Actual Use Study

Bayer497 enrolled

Overview

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

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

497

Conditions

Pain

Interventions

Naproxen Sodium ER (BAYH6689)DRUG

Consumer use of Extended Release Naproxen Sodium

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (24)

Unnamed facility

Anaheim, California, United States

Unnamed facility

Oceanside, California, United States

Outcomes

Primary Outcomes

Use Days With One or More Misuse Occasions

Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.

Time frame: 1 month

Secondary Outcomes

Dosing Occasions With One and More Than One Tablet Taken

Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.

Time frame: 1 month

Use Days With and Without Next Dose Less Than 22 Hours Later

Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.

Time frame: 1 month

Number of Subjects With and Without More Than One Tablet Taken Per Dose

Time frame: 1 month

Number of Subjects With and Without Next Dose Less Than 22 Hours Later

This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.