Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

Analgesia Clinical Trial

Official title:

Ibuprofen 600 mg Immediate Release/Extended Release (IR/ER) Caplet Self-Selection, Safety and Compliance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789606
• Other study ID #: B4371008
• Secondary ID: AK-10-11
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2012
• Last updated: July 25, 2014
• Start date: September 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• at least 12 years of age

• use of at least 5 doses per month of over-the-counter pain relievers over the past 3 months

• provide written informed consent (subjects 12-<18 years of age provide a written assent and parent/guardian will provide written informed consent)

• capable of and willing to swallow the study medication

Exclusion Criteria:

• participated in other research studies in the last 6 months

• they or someone else in their household work for a pharmaceutical company, is a relative of study site personnel involved with the study, or an immediate family member is already enrolled in the study

• have a history of known allergies to ibuprofen, aspirin, or other NSAIDs

• have a history of heart surgery in the last 60 days or planned heart surgery in the next 60 days

• female subjects are pregnant or breast feeding

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Ibuprofen 600 mg Immediate Release/Extended Release Caplet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Blaine	Minnesota
United States	Pfizer Investigational Site	Elk River	Minnesota
United States	Pfizer Investigational Site	Griffin	Georgia
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kenmore	Washington
United States	Pfizer Investigational Site	Montpelier	Virginia
United States	Pfizer Investigational Site	Ogden	Utah
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Savannah	Missouri
United States	Pfizer Investigational Site	Snohomish	Washington
United States	Pfizer Investigational Site	St. Louis Park	Minnesota
United States	Pfizer Investigational Site	Taos	New Mexico
United States	Pfizer Investigational Site	West Jordan	Utah
United States	Pfizer Investigational Site	Yorba Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Selection Arm: Percentage of participants who either correctly select to use or correctly de-select not to use the 600 mg IR/ER product, based on typical duration of pain.	Among those who select the 600 mg IR/ER product, the percentage of subjects who report their typical duration of pain, if left untreated, to be greater than or equal to 6 hours, will be considered to have corectly self-selected. Likewise, among those who do not select the 600 mg product who report their typical duration of pain, if left untreated, to be less than 6 hours will be considered to have correctly de-selected the IR/ER product.	30 days	No
Primary	Compliance Arm: Percentage of participants who use the product for more than 10 days (not necessarily consecutive) during the study and have an average daily dose of greater than 1600 mg.	Excessive use of the product is defined as: (1) Using the product for more than 10 days (not necessarily consecutive) during the study and having an average daily dose greater than 1600 mg OR (2) Using the product for 10 days or less during the study, taking more than 20 caplets and having an average daily dose greater than 1600 mg.	30 days	No
Primary	Compliance Arm: Percentage of participants who use the product for 10 days or less during the study, take more than 20 caplets and have an average daily dose of greater than 1600 mg.	Excessive use of the product is defined as: (1) Using the product for more than 10 days (not necessarily consecutive) during the study and having an average daily dose greater than 1600 mg OR (2) Using the product for 10 days or less during the study, taking more than 20 caplets and having an average daily dose greater than 1600 mg.	30 days	No
Secondary	Dosing patterns among subjects who use the product excessively.		30 days	No
Secondary	Dosing patterns among subjects who are inappropriate self-selectors.		30 days	No
Secondary	Dosing patterns related to exceeding 1200 mg/day.		30 days	No
Secondary	Dosing paterns related to exceeding 600 mg/dose.		30 days	No
Secondary	Average daily dose (within subject).		30 days	No
Secondary	Maximum daily dose.		30 days	No

External Links

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