Self Selection Trial of Naproxen Sodium

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Naproxen

Criteria

Inclusion Criteria:

• At least 12 years of age

• Report taking at least one dose of Over-the-counter (OTC) analgesic for pain in the past month

• Able to read and understand English

• Provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent)

• Provide contact information

Exclusion Criteria:

• Have participated in a trial involving OTC analgesics in the last 6 months

• They or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels)

• Have a history of known allergies to Nonsteroidal Antiinflammatory Drugs (NSAIDs) (i.e., naproxen, ibuprofen, acetaminophen, aspirin, etc.)

• Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days

• Female subjects who have a positive urine pregnancy test or who are breastfeeding.