Naproxen Sodium Extended-Release Actual Use Study

NCT00751400 | Completed Phase 3 Results

• 2 other identifiers: 131292014-005268-13
• Study Type: interventional
• Target: 497
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Pain

Keywords

Non-prescription

Outcome Measures

Primary Outcomes (1)

• Use Days With One or More Misuse Occasions

  Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.

  1 month

Secondary Outcomes (9)

• Dosing Occasions With One and More Than One Tablet Taken

  1 month

• Use Days With and Without Next Dose Less Than 22 Hours Later

  1 month

• Number of Subjects With and Without More Than One Tablet Taken Per Dose

  1 month

• Number of Subjects With and Without Next Dose Less Than 22 Hours Later

  1 month

• Number of Subjects With and Without More Than 660 mg at Least Once

  1 month

Study Arms (1)

Naproxen Sodium ER (BAYH6689)

EXPERIMENTAL

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

Drug: Naproxen Sodium ER (BAYH6689)

Interventions

Naproxen Sodium ER (BAYH6689) DRUG

Consumer use of Extended Release Naproxen Sodium

Naproxen Sodium ER (BAYH6689)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Pegus Research, Inc.: collaborator

Study Sites (24)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Oceanside, California, 92054, United States

Location

Unknown Facility

San Dimas, California, 91773, United States

Location

Unknown Facility

Overland Park, Kansas, 66209, United States

Location

Unknown Facility

Anoka, Minnesota, 55303, United States

Location

Unknown Facility

Blaine, Minnesota, 55443, United States

Location

Unknown Facility

Elk River, Minnesota, 55330, United States

Location

Unknown Facility

Saint Francis, Minnesota, 55070, United States

Location

Unknown Facility

Saint Louis Park, Minnesota, 55426, United States

Location

Unknown Facility

Belton, Missouri, 64012, United States

Location

Unknown Facility

Saint Joseph, Missouri, 64504, United States

Location

Unknown Facility

Savannah, Missouri, 64485, United States

Location

Unknown Facility

Cary, North Carolina, 27513, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27514, United States

Location

Unknown Facility

Raleigh, North Carolina, 27606, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Bountiful, Utah, 84010, United States

Location

Unknown Facility

Ogden, Utah, 84401, United States

Location

Unknown Facility

Salt Lake City, Utah, 84102, United States

Location

Unknown Facility

Syracuse, Utah, 84075, United States

Location

Unknown Facility

West Jordan, Utah, 84088, United States

Location

Unknown Facility

Kenmore, Washington, 98028, United States

Location

Unknown Facility

Seattle, Washington, 98148, United States

Location

Unknown Facility

Snohomish, Washington, 98290, United States

Location

Related Links

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

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

No control group, detailed data collected for up to 10 days during 1 month followup, data recall by subjects may vary

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 25, 2015
• Results First Posted: May 17, 2011

Record last verified: 2015-08

Locations

US (24)