Naproxen Sodium Extended-Release Actual Use Study - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00751400

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 (BAYH6689)	Phase III

MedlinePlus related topics: Over-the-Counter Medicines

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Dose Comparison, Single Group Assignment
Official Title:	An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting

Further study details as provided by Bayer:

Primary Outcome Measures:

self reported use behavior data [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of variety of usage patterns by doing occasions or use day [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment:	466
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
Arm 1: Experimental	Drug: Naproxen (BAYH6689) Consumer use of Extended Release Naproxen Sodium

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 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 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

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

Locations

United States, California

Anaheim, California, United States, 92801

San Dimas, California, United States, 91773

Oceanside, California, United States, 92054
United States, Kansas

Overland Park, Kansas, United States, 66209
United States, Minnesota

St. Louis Park, Minnesota, United States, 55426

Blaine, Minnesota, United States, 55443

St. Francis, Minnesota, United States, 55070

Anoka, Minnesota, United States, 55303

Elk River, Minnesota, United States, 55330
United States, Missouri

Belton, Missouri, United States, 64012

Savannah, Missouri, United States, 64485

St. Joseph, Missouri, United States, 64504
United States, North Carolina

Raleigh, North Carolina, United States, 27606

Chapel Hill, North Carolina, United States, 27514

Raleigh, North Carolina, United States, 27612

Cary, North Carolina, United States, 27513
United States, Utah

Ogden, Utah, United States, 84401

Bountiful, Utah, United States, 84010

Syracuse, Utah, United States, 84075

Salt Lake City, Utah, United States, 84102

West Jordan, Utah, United States, 84088
United States, Washington

Snohomish, Washington, United States, 98290

Kenmore, Washington, United States, 98028

Seattle, Washington, United States, 98148

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Consumer Care Inc. ( Therapeutic Area Head )
Study ID Numbers:	13129
Study First Received:	September 11, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00751400 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Non-prescription

Study placed in the following topic categories:

Anti-Inflammatory Agents
Naproxen
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal

Pain
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009