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

Purpose

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

Condition	Intervention	Phase
Non-Prescription	Drug: Naproxen Sodium ER	Phase III

MedlinePlus related topics:

Over-the-Counter Medicines

ChemIDplus related topics:

Naproxen sodium Naproxen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, 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 ]

Estimated Enrollment:	500
Study Start Date:	July 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Naproxen Sodium ER Consumer use of Extended Release Naproxin 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., Naproxin, 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

Contacts


Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com

Contact: For trial location information (Phone menu options "3" or "4")	(+)1-888-84 22937

Locations


United States, California
		Not yet recruiting
	Anaheim, California, United States, 92801
		Not yet recruiting
	San Dimas, California, United States, 91773
		Not yet recruiting
	Oceanside, California, United States, 92054

United States, Kansas
		Not yet recruiting
	Overland Park, Kansas, United States, 66209

United States, Minnesota
		Not yet recruiting
	St. Louis Park, Minnesota, United States, 55426
		Not yet recruiting
	Blaine, Minnesota, United States, 55443
		Not yet recruiting
	St. Francis, Minnesota, United States, 55070
		Not yet recruiting
	Anoka, Minnesota, United States, 55303
		Not yet recruiting
	Elk River, Minnesota, United States, 55330

United States, Missouri
		Not yet recruiting
	Belton, Missouri, United States, 64012
		Not yet recruiting
	Savannah, Missouri, United States, 64485
		Not yet recruiting
	St. Joseph, Missouri, United States, 64504

United States, North Carolina
		Not yet recruiting
	Raleigh, North Carolina, United States, 27606
		Not yet recruiting
	Chapel Hill, North Carolina, United States, 27514
		Not yet recruiting
	Raleigh, North Carolina, United States, 27612
		Not yet recruiting
	Cary, North Carolina, United States, 27513

United States, Utah
		Recruiting
	Ogden, Utah, United States, 84401
		Not yet recruiting
	Bountiful, Utah, United States, 84010
		Not yet recruiting
	Syracuse, Utah, United States, 84075
		Not yet recruiting
	Salt Lake City, Utah, United States, 84102
		Not yet recruiting
	West Jordan, Utah, United States, 84088

United States, Washington
		Not yet recruiting
	Snohomish, Washington, United States, 98290
		Not yet recruiting
	Kenmore, Washington, United States, 98028
		Not yet recruiting
	Seattle, Washington, United States, 98148

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More 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

Responsible Party:	( Therapeutic Area Head )
Study ID Numbers:	13129
First Received:	September 11, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00751400
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Non-prescription

Study placed in the following topic categories:

Naproxen

Additional relevant MeSH terms:

Anti-Inflammatory Agents

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 October 03, 2008

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