Naproxen Sodium Extended-Release Actual Use Study

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Pegus Research, Inc.
• Treatments: Naproxen

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