Naproxen Sodium Extended-Release Actual Use Study

An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Naproxen Sodium ER (BAYH6689)

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)

• Study Type: Interventional
• Enrollment (Actual): 497
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
    • Oceanside, California, United States, 92054
    • San Dimas, California, United States, 91773
  • Kansas
    • Overland Park, Kansas, United States, 66209
  • Minnesota
    • Anoka, Minnesota, United States, 55303
    • Blaine, Minnesota, United States, 55443
    • Elk River, Minnesota, United States, 55330
    • St. Francis, Minnesota, United States, 55070
    • St. Louis Park, Minnesota, United States, 55426
  • Missouri
    • Belton, Missouri, United States, 64012
    • Savannah, Missouri, United States, 64485
    • St. Joseph, Missouri, United States, 64504
  • North Carolina
    • Cary, North Carolina, United States, 27513
    • Chapel Hill, North Carolina, United States, 27514
    • Raleigh, North Carolina, United States, 27612
    • Raleigh, North Carolina, United States, 27606
  • Utah
    • Bountiful, Utah, United States, 84010
    • Ogden, Utah, United States, 84401
    • Salt Lake City, Utah, United States, 84102
    • Syracuse, Utah, United States, 84075
    • West Jordan, Utah, United States, 84088
  • Washington
    • Kenmore, Washington, United States, 98028
    • Seattle, Washington, United States, 98148
    • Snohomish, Washington, United States, 98290

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naproxen Sodium ER (BAYH6689); subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever	Drug: Naproxen Sodium ER (BAYH6689); Consumer use of Extended Release Naproxen Sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 month
Number of Subjects With and Without More Than One Tablet Taken Per Dose		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.	1 month
Number of Subjects With and Without More Than 660 mg at Least Once	This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion).	1 month
Average Daily Dose		1 month
Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days	This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing	1 month
Number of Total Dosing Occasions Per Subject	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.	1 month
Number of Dosing Occasions Per Subject That Exceeded 660 mg	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.	1 month

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Pegus Research, Inc.

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: September 11, 2008
• First Submitted That Met QC Criteria: September 11, 2008
• First Posted (Estimate): September 12, 2008

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: August 12, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Non-prescription
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: 13129; 2014-005268-13 (EudraCT Number)