Naproxen Sodium Extended-Release Actual Use Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Naproxen Sodium ER (BAYH6689)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751400

13129

2014-005268-13 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Issues on adverse event data are addressed in the Adverse Event section.

The following acronyms and abbreviations were used in the results section.

• General Educational Development (GED)

Enrollment: 497 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

497 participants in 1 patient group

Naproxen Sodium ER (BAYH6689)

Experimental group

Description:

subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever

Treatment:

Drug: Naproxen Sodium ER (BAYH6689)