Self Selection Trial of Naproxen Sodium

NCT01383486 | Completed Phase 3 Results

• 2 other identifiers: 158332014-005305-20
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Pain

Keywords

Self Selection Tria

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours

  Participants were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B).

  up to 14 days

Secondary Outcomes (2)

• The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours

  Within 24 hours of their selection decision taken up to 14 days

• The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours

  Up to 14 days

Study Arms (1)

Naproxen Sodium ER (BAYH6689) or Advil IR

EXPERIMENTAL

Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.

Drug: Naproxen sodium ER (BAYH6689); Drug: Advil

Interventions

Naproxen sodium ER (BAYH6689) DRUG

Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain

Naproxen Sodium ER (BAYH6689) or Advil IR

Advil DRUG

Commercially available Advil; oral caplet upon incidence of pain

Naproxen Sodium ER (BAYH6689) or Advil IR

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (10)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Yorba Linda, California, 92886, United States

Location

Unknown Facility

Pembroke Pines, Florida, 33026, United States

Location

Unknown Facility

Griffin, Georgia, 30224, United States

Location

Unknown Facility

Andover, Minnesota, 55304, United States

Location

Unknown Facility

Roseville, Minnesota, 55113, United States

Location

Unknown Facility

Bountiful, Utah, 84010, United States

Location

Unknown Facility

West Jordan, Utah, 84088, United States

Location

Unknown Facility

Bellevue, Washington, 98007, United States

Location

Unknown Facility

Seattle, Washington, 98122, United States

Location

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Head Clinical and Medical Affairs
• Organization: Bayer HealthCare LLC, Consumer Care

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 15, 2015
• Results First Posted: November 29, 2012

Record last verified: 2015-06

Locations

US (10)