Naproxen Sodium Extended-Release Actual Use Study

Pain Clinical Trial

Official title:

An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751400
• Other study ID #: 13129
• Secondary ID: 2014-005268-13
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2008
• Last updated: August 12, 2015
• Start date: July 2008
• Est. completion date: November 2008

Study information

• Verified date: August 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Naproxen Sodium ER (BAYH6689)
Consumer use of Extended Release Naproxen Sodium

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Pegus Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Dosing Occasions With One and More Than One Tablet Taken	Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.	1 month	No
Secondary	Use Days With and Without Next Dose Less Than 22 Hours Later	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 one use-day. If a subject reported product consumption on three different days this resulted in three 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	No
Secondary	Number of Subjects With and Without More Than One Tablet Taken Per Dose		1 month	No
Secondary	Number of Subjects With and Without Next Dose Less Than 22 Hours Later	This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved.	1 month	No
Secondary	Number of Subjects With and Without More Than 660 mg at Least Once	This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion).	1 month	No
Secondary	Average Daily Dose		1 month	No
Secondary	Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days	This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing	1 month	No
Secondary	Number of Total Dosing Occasions Per Subject	Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.	1 month	No
Secondary	Number of Dosing Occasions Per Subject That Exceeded 660 mg	Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.	1 month	No

External Links

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