Actual Use Trial of Naproxen Sodium

NCT01427803 | Completed Phase 3 Results

• 1 other identifier: 15647
• Study Type: interventional
• Target: 778
• Locations: 1 country
• Sites: 34

Brief Summary

An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.

Conditions

Pain

Keywords

Actual Use Trial

Outcome Measures

Primary Outcomes (1)

• Estimated Percentage of Misuse for Non-Therapeutic Reasons

  The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.

  28 days

Secondary Outcomes (8)

• Non-therapeutic Reasons for Misuse

  28 days

• Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course

  28 days

• Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days

  28 days

• Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day

  28 days

• Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken

  28 days

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Naproxen Sodium ER (BAYH6689)

Interventions

Naproxen Sodium ER (BAYH6689) DRUG

BAYH6689; oral tablet used as needed upon incidence of pain

Arm 1

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 OTC analgesics for pain on at least 5 days in the last month
• Report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it
• 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
• Purchase the investigational product

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 NSAIDs (i.e., naproxen, ibuprofen, 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) are pregnant or breastfeeding

Sponsors & Collaborators

• Bayer: lead

Study Sites (34)

Unknown Facility

Hoover, Alabama, 35226, United States

Location

Unknown Facility

McCalla, Alabama, 35111-3406, United States

Location

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Pinson, Alabama, 35126, United States

Location

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Mesa, Arizona, 85202, United States

Location

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Anaheim, California, 92801, United States

Location

Unknown Facility

Oceanside, California, 92054, United States

Location

Unknown Facility

Yorba Linda, California, 92886, United States

Location

Unknown Facility

Overland Park, Kansas, 66209, United States

Location

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Baltimore, Maryland, 21228, United States

Location

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Andover, Minnesota, 55304, United States

Location

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Elk River, Minnesota, 55330, United States

Location

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Fridley, Minnesota, 55432, United States

Location

Unknown Facility

Northfield, Minnesota, 55057-2434, United States

Location

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Rosemount, Minnesota, 55068, United States

Location

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Roseville, Minnesota, 55113, United States

Location

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Kansas City, Missouri, 64111, United States

Location

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Saint Joseph, Missouri, 64504, United States

Location

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Savannah, Missouri, 64485, United States

Location

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Albuquerque, New Mexico, 87104, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87107, United States

Location

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Taos, New Mexico, 87571, United States

Location

Unknown Facility

Bountiful, Utah, 84010, United States

Location

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Hurricane, Utah, 84737, United States

Location

Unknown Facility

Layton, Utah, 84041, United States

Location

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Ogden, Utah, 84401, United States

Location

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Salt Lake City, Utah, 84102, United States

Location

Unknown Facility

Salt Lake City, Utah, 84121, United States

Location

Unknown Facility

Syracuse, Utah, 84075, United States

Location

Unknown Facility

West Jordan, Utah, 84088, United States

Location

Unknown Facility

Montpelier, Virginia, 23192, United States

Location

Unknown Facility

Richmond, Virginia, 23221, United States

Location

Unknown Facility

Bellevue, Washington, 98007, United States

Location

Unknown Facility

Kenmore, Washington, 98028, United States

Location

Unknown Facility

Snohomish, Washington, 98290, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Head 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 2, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 15, 2015
• Results First Posted: May 20, 2013

Record last verified: 2014-04

Locations

US (34)