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AnalgesiaPhase 3NCT01789606

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

A Phase 3 study testing Ibuprofen 600 mg Immediate Release/Extended Release Caplet in people with Analgesia, run by Pfizer at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Analgesia
What is being tested?
Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,083 participants
Where
18 sitesUnited States
Study dates
24 Sep 2012to 3 Jun 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Duran Central Pharmacy

    Albuquerque, New Mexico, 87104

  • Medical Arts Rexall Pharmacy

    Anaheim, California, 92801

  • Catonsville Pharmacy

    Baltimore, Maryland, 21228

  • Goodrich Pharmacy

    Blaine, Minnesota, 55434

  • Kemper Drug

    Elk River, Minnesota, 55330

  • Wynn's Pharmacy Inc.

    Griffin, Georgia, 30224

  • Albers' Medical Pharmacy

    Kansas City, Missouri, 64111

  • Ostrom Drugs

    Kenmore, Washington, 98028

  • Montpelier Pharmacy, Inc.

    Montpelier, Virginia, 23192

  • The Medicine Shoppe

    Ogden, Utah, 84401

  • Stark Pharmacy

    Overland Park, Kansas, 66209

  • Cub Pharmacy Number 1924

    Saint Louis Park, Minnesota, 55426

  • The Medicine Shoppe

    Salt Lake City, Utah, 84121

  • Countryside Pharmacy

    Savannah, Missouri, 64485

  • Kusler's Pharmacy

    Snohomish, Washington, 98290

  • Total Health and Wellness Center of Taos

    Taos, New Mexico, 87571

  • Family Plaza Pharmacy

    West Jordan, Utah, 84088

  • B and B Pharmacy

    Yorba Linda, California, 92886

Other trials in United States

About this study

Official title: Ibuprofen 600 Mg Immediate Release/Extended Release (IR/ER) Caplet Self-selection, Safety And Compliance Study

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.

Conditions
Analgesia
Being tested
Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Keywords
Self-selection and actual use/compliance trial.
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01789606
Study groupRoleWhat they receive
Ibuprofen 600 mg Immediate Release/Extended Release CapletExperimentalNot described
Receives: Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. 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.

    Measured: Day 1

  4. 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.

    Measured: Day 1

  5. 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.

    Measured: Day 1 up to Day 30

  6. 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.

    Measured: Day 1 up to Day 30

Secondary outcomes (9)

  1. Average Daily Dose Among Excessive Users

    Excessive users included all participants who used the study medication for more than 10 days (not necessarily consecutive) during study period with an average daily dose of >1600 mg or all participants who used the study medication for <=10 days during study period, used more than 20 tablets and had an average daily dose of >1600 mg.

    Measured: Day 1 up to Day 30

  2. Number of Dosing Days Among Inappropriate Users

    Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, if left untreated, based on the information provided at the follow up interview.

    Measured: Day 1 up to Day 30

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

    In this outcome measure, number of pain episodes treated with single dose or multiple dose per day among inappropriate users were reported. Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, based on the information provided at the follow up interview.

    Measured: Day 1 up to Day 30

  4. Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram

    Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.

    Measured: Day 1 up to Day 30

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

    In this outcome measure, number of treatment days exceeding the daily dose of 1200 mg, excluding the days when severe symptoms were treated, were reported.

    Measured: Day 1 up to Day 30

  6. Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram

    In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.

    Measured: Day 1 up to Day 30

  7. Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms

    In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported.

    Measured: Day 1 up to Day 30

  8. Average Daily Dose of Study Medication

    Measured: Day 1 up to Day 30

  9. Maximum Daily Dose of Study Medication

    Measured: Day 1 up to Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2013 (estimated)
  2. Study start24 Sep 2012
  3. Primary completion3 Jun 2013
  4. Study completion3 Jun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,083 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01789606
Sponsor's protocol ID
B4371008
Other IDs
AK-10-11
Status last verified
Jul 2017
First submitted
19 Sep 2012
Last updated
28 Aug 2017
Data monitoring committee
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 27184785

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibuprofen 600 mg Immediate Release/Extended Release Caplet in people with Analgesia, run by Pfizer at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01789606, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.

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