Self Selection Trial of Naproxen Sodium (KEIFER SST)

• Conditions: Pain; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2014-005305-20-Outside-EU/EEA
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-09
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 250

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 250
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified