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Completed

NCT Number: NCT00751400

Naproxen Sodium Extended-Release Actual Use Study

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anaheim, California, United States

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naproxen sodium ER (BAYH6689)

Drug

Consumer use of Extended Release Naproxen Sodium

Primary outcomes

  1. Use Days With One or More Misuse Occasions

    Time frame: 1 month

    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.

Secondary outcomes

  1. Dosing Occasions With One and More Than One Tablet Taken

    Time frame: 1 month

    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.

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

    Time frame: 1 month

    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.

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

    Time frame: 1 month

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

    Time frame: 1 month

    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.

  5. Number of Subjects With and Without More Than 660 mg at Least Once

    Time frame: 1 month

    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).

  6. Average Daily Dose

    Time frame: 1 month

  7. Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days

    Time frame: 1 month

    This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing

  8. Number of Total Dosing Occasions Per Subject

    Time frame: 1 month

    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.

  9. Number of Dosing Occasions Per Subject That Exceeded 660 mg

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Pegus Research, Inc.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2008
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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