NCT01789606

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,083

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

September 24, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2013

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

August 28, 2017

Completed
Last Updated

August 28, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

September 19, 2012

Results QC Date

July 24, 2017

Last Update Submit

July 24, 2017

Conditions

Analgesia

Keywords

Self-selection and actual use/compliance trial.

Outcome Measures

Primary Outcomes (6)

  • Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study Medication

    Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (\<) 6 hours, if left untreated.

    Day 1

  • Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed Opportunity

    Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of \<6 hours, if left untreated. Participants were classified as "missed opportunity" cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain \>=6 hours.

    Day 1

  • Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours

    Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain \<6 hours were reported in this outcome measure.

    Day 1

  • Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours

    Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain \>=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.

    Day 1

  • Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg

    Percentage of participants with the use of study medication for \>10 days with an average daily dose of \>1600 mg were reported in this outcome measure.

    Day 1 up to Day 30

  • Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mg

    Percentage of participants who used the study medication for \<=10 days and used more than 20 tablets with an average daily dose of \>1600 mg were reported in this outcome measure.

    Day 1 up to Day 30

Secondary Outcomes (9)

  • Average Daily Dose Among Excessive Users

    Day 1 up to Day 30

  • Number of Dosing Days Among Inappropriate Users

    Day 1 up to Day 30

  • Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users

    Day 1 up to Day 30

  • Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram

    Day 1 up to Day 30

  • Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms

    Day 1 up to Day 30

  • +4 more secondary outcomes

Study Arms (1)

Ibuprofen 600 mg Immediate Release/Extended Release Caplet

EXPERIMENTAL
Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet

Interventions

Ibuprofen 600 mg Immediate Release/Extended Release CapletDRUG

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.

Ibuprofen 600 mg Immediate Release/Extended Release Caplet

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Medical Arts Rexall Pharmacy

Anaheim, California, 92801, United States

Location

B and B Pharmacy

Yorba Linda, California, 92886, United States

Location

Wynn's Pharmacy Inc.

Griffin, Georgia, 30224, United States

Location

Stark Pharmacy

Overland Park, Kansas, 66209, United States

Location

Catonsville Pharmacy

Baltimore, Maryland, 21228, United States

Location

Goodrich Pharmacy

Blaine, Minnesota, 55434, United States

Location

Kemper Drug

Elk River, Minnesota, 55330, United States

Location

Cub Pharmacy Number 1924

Saint Louis Park, Minnesota, 55426, United States

Location

Albers' Medical Pharmacy

Kansas City, Missouri, 64111, United States

Location

Countryside Pharmacy

Savannah, Missouri, 64485, United States

Location

Duran Central Pharmacy

Albuquerque, New Mexico, 87104, United States

Location

Total Health and Wellness Center of Taos

Taos, New Mexico, 87571, United States

Location

The Medicine Shoppe

Ogden, Utah, 84401, United States

Location

The Medicine Shoppe

Salt Lake City, Utah, 84121, United States

Location

Family Plaza Pharmacy

West Jordan, Utah, 84088, United States

Location

Montpelier Pharmacy, Inc.

Montpelier, Virginia, 23192, United States

Location

Ostrom Drugs

Kenmore, Washington, 98028, United States

Location

Kusler's Pharmacy

Snohomish, Washington, 98290, United States

Location

Related Publications (1)

  • Paluch E, Jayawardena S, Wilson B, Farnsworth S. Consumer self-selection, safety, and compliance with a novel over-the-counter ibuprofen 600-mg immediate-release and extended-release tablet. J Am Pharm Assoc (2003). 2016 Jul-Aug;56(4):397-404. doi: 10.1016/j.japh.2016.03.003. Epub 2016 May 13.

    PMID: 27184785DERIVED

Related Links

MeSH Terms

Conditions

Agnosia

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2012

First Posted

February 12, 2013

Study Start

September 24, 2012

Primary Completion

June 3, 2013

Study Completion

June 3, 2013

Last Updated

August 28, 2017

Results First Posted

August 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests

Locations

US(18)