Naproxen Sodium Extended-Release Actual Use Study

This study has been completed.
Sponsor:
Collaborator:
Pegus Research, Inc.
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00751400
First received: September 11, 2008
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Pain
Drug: Naproxen Sodium ER (BAYH6689)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Use Days With One or More Misuse Occasions [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Dosing Occasions With One and More Than One Tablet Taken [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.

  • Use Days With and Without Next Dose Less Than 22 Hours Later [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With and Without More Than One Tablet Taken Per Dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Number of Subjects With and Without Next Dose Less Than 22 Hours Later [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With and Without More Than 660 mg at Least Once [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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).

  • Average Daily Dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing

  • Number of Total Dosing Occasions Per Subject [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.

  • Number of Dosing Occasions Per Subject That Exceeded 660 mg [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Enrollment: 497
Study Start Date: July 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751400

Locations
United States, California
Anaheim, California, United States, 92801
Oceanside, California, United States, 92054
San Dimas, California, United States, 91773
United States, Kansas
Overland Park, Kansas, United States, 66209
United States, 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
United States, Missouri
Belton, Missouri, United States, 64012
Savannah, Missouri, United States, 64485
St. Joseph, Missouri, United States, 64504
United States, 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
United States, 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
United States, Washington
Kenmore, Washington, United States, 98028
Seattle, Washington, United States, 98148
Snohomish, Washington, United States, 98290
Sponsors and Collaborators
Bayer
Pegus Research, Inc.
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00751400     History of Changes
Other Study ID Numbers: 13129
Study First Received: September 11, 2008
Results First Received: January 3, 2011
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Non-prescription

Additional relevant MeSH terms:
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014