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PainPhase 3NCT03722238

Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers

A Phase 3 study testing Ibuprofen 600 mg Immediate Release/Extended Release Caplet in people with Pain, run by Pfizer at 27 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This will be an open-label, multicenter, 30-day, unsupervised AUS among targeted (at-risk) adult and adolescent consumers designed to mimic an OTC-like environment. More specifically, "at-risk" consumers, as discussed with the FDA, will comprise elderly consumers (>65 years of age), consumers with an increased risk of… Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Pain
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
613 participants
Where
27 sitesUnited States
Study dates
27 Dec 2018to 28 Oct 2019
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

  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
  • Male or female 18 years of age or older, has history of using oral OTC analgesics at OTC dose levels, defined as taking at least 5 doses/month on average during the past 3 months, and qualifies for inclusion in at least one risk group category, including cardiovascular, gastrointestinal bleeding, history of severe pain (≥5 episodes in last month) or >65 years of age (see Groups 1 4 in Section 3.1).
  • OR Male or female 12-17 years of age and has history of using oral OTC analgesics at OTC dose levels, defined as taking at least 5 doses/month on average during the past 3 months.
  • Evidence of a personally signed and dated informed consent document (ICD), and in the case of minor adolescent subjects (12-17 years of age or adolescent subjects residing in states where the age of majority is > than 18), an assent document, indicating that the subject and where applicable a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study.
  • Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
  • Willing (or in the case of adolescent subjects, the parent/guardian is willing) and able to purchase study medication.
  • Agrees the product purchased is for subject's own use and not to be shared.
  • Willing (or in the case of adolescent subjects, the parent/guardian is willing) and able to provide contact information for follow up purposes.

Who cannot join

  • Subjects with any of the following characteristics/conditions will not be included in the study:
  • Subject (or parent/guardian, if applicable) cannot read, speak, and/or understand English.
  • Trained or employed as a healthcare professional.
  • Subject or someone else in the household is employed by a pharmaceutical company, medical practice or hospital, pharmacy, managed care or health insurance organization or a contract research organization.
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or potential subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Participation in other studies involving investigational drug(s) within 6 months prior to study entry and/or during study participation.
Show all 18Show fewer
  • Known hypersensitivity to ibuprofen, aspirin, or any other NSAIDs.
  • Subjects with the following clinical conditions which place them at excessively high risk or have ≥20% 10 year risk for atherosclerotic cardiovascular disease (ASCVD), as defined by the 2013 ACC/AHA Guidelines on the Assessment of Atherosclerotic Cardiovascular Risk, will not be included in the study: clinically established coronary heart disease; cerebrovascular disease; peripheral artery disease; abdominal aortic aneurysm; and chronic kidney disease. Subjects who have experienced a prior non fatal cardiovascular disease event (angina, heart failure, heart disease, heart attack, stroke/transient ischemic attack) or have had heart surgery or who currently have uncontrolled high blood pressure (either by self report or by measured systolic blood pressure higher than 180 mmHg or diastolic pressure higher than 120 mmHg at the time of the enrollment interview), will also be excluded from the study.
  • Subjects with concurrent or recent (within 30 days) use of anticoagulants, a prior history of complicated peptic ulcer, or a gastrointestinal bleeding event requiring hospitalization or blood transfusion.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product (IP) administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Pregnant female subjects; breastfeeding female subjects; and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 28 days after the end of their 30-Day Use Phase or, for subjects who use the investigational product after Day 30, 28 days after the last recorded dose of investigational product.
  • 18 years of age or older and classified as normal literacy (REALM Test score ≥61) after the normal literacy group quotas (approximately 70% of adult subjects) are full or refuses to complete the REALM Test (note there is no corresponding literacy exclusion criterion for adolescent subjects based on REALM Teen score).
  • 18 years of age or older and classified as moderate (less frequent) oral OTC pain reliever user (<30 doses per month on average in the preceding 3 months) after the moderate user group quotas (approximately 33% of adult subjects) are full.
  • Not capable of swallowing a vitamin sized tablet.
  • Refuses to participate in required assessments (such as urine pregnancy, finger stick cholesterol or blood pressure tests, or unable or unwilling to comply with electronic diary procedures).
  • The following additional exclusion criteria will be applied for adolescent subjects only (12-17 years of age):
  • Has developmental or learning disabilities that, in the judgment of the parent/guardian or the investigator, would interfere with study participation.
  • Another adolescent child from the family is already enrolled into the study, or parent/guardian does not agree that only one adolescent child from the family or household will be enrolled into the study.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Goodrich Pharmacy

    Anoka, Minnesota, 55303

  • Rice's Pharmacy

    Beaver Dam, Kentucky, 42320

  • Family Prescription Center

    Bethlehem, Pennsylvania, 18015

  • Dakota Pharmacy of Bismarck

    Bismarck, North Dakota, 58501

  • Bountiful Drug

    Bountiful, Utah, 84010

  • Catonsville Pharmacy

    Catonsville, Maryland, 21228

  • Medical Center Compounding Pharmacy & Health Center

    Cleveland, Tennessee, 37311

  • Kemper Corner Drug

    Elk River, Minnesota, 55330

  • Huff's Drug Store

    Ellijay, Georgia, 30540

  • The Medicine Shoppe and Elsberry Pharmacy

    Elsberry, Missouri, 63343

  • RxXPress Health Mart Pharmacy

    Grove City, Pennsylvania, 16127

  • Family Care Pharmacy

    Highland, Illinois, 62249

  • Mills Pharmacy at Bluff Park

    Hoover, Alabama, 35226

  • Summerwood Pharmacy and Compounding

    Houston, Texas, 77044

  • Albers Medical Pharmacy

    Kansas City, Missouri, 64111

  • Buckeye Drugs

    Lebanon, Tennessee, 37087

  • Community Clinical Pharmacy

    Mesa, Arizona, 85202

  • Coconut Grove Pharmacy

    Miami, Florida, 33133

  • Texas Road Pharmacy

    Monroe, New Jersey, 08831

  • Montpelier Pharmacy, Inc.

    Montpelier, Virginia, 23192

  • Summerfield Pharmacy

    Riverview, Florida, 33578

  • Cub Pharmacy #744

    Rosemount, Minnesota, 55068

  • The Medicine Center

    Salt Lake City, Utah, 84121

  • Countryside Pharmacy

    Savannah, Missouri, 64485

  • The Medicine Shoppe #708

    Sherman, Texas, 75092

  • ACACIA Apothecary and Wellness

    Tucson, Arizona, 85704

  • BrickStreet Pharmacy

    Tyler, Texas, 75701

Other trials in United States

About this study

Official title: MULTICENTER ACTUAL USE AND COMPLIANCE STUDY OF IBUPROFEN 600 MG IMMEDIATE RELEASE/EXTENDED RELEASE TABLETS AMONG TARGETED (AT-RISK) CONSUMERS IN A SIMULATED OVER-THE-COUNTER ENVIRONMENT

This will be an open-label, multicenter, 30-day, unsupervised AUS among targeted (at-risk) adult and adolescent consumers designed to mimic an OTC-like environment. More specifically, "at-risk" consumers, as discussed with the FDA, will comprise elderly consumers (>65 years of age), consumers with an increased risk of gastrointestinal (GI) bleeding or cardiovascular (CV) adverse events, consumers who experience severe pain, low literacy subjects, and adolescents (12-17 years of age). The total number of subjects expected to enroll into the study is approximately 820. Sites will be pharmacies in diverse geographic locations around the US. Prospective adult subjects will be recruited via general population and targeted risk condition advertising (although participants will not be informed as to specific health conditions for which they are being recruited), while adolescents will be recruited using targeted, outbound pre-recruiting telephone calls. Subjects (or the parents/guardians of prospective adolescent subjects) responding to the advertisements or recruitment calls will be initially screened by telephone, and eligibility will subsequently be verified in-person at the pharmacy site.

Conditions
Pain
Being tested
Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Medical subject headings
Pain

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 Tablet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.

Study groups in NCT03722238
Study groupRoleWhat they receive
Ibuprofen 600 mg Immediate Release/Extended Release TabletsExperimentalIbuprofen 600 mg Immediate Release/Extended Release Tablets
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 in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period

    Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  2. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period

    Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  3. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period

    Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  4. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period

    Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

Secondary outcomes (36)

  1. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period

    Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  2. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period

    Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  3. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period

    Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  4. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period

    Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  5. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse

    Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  6. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse

    Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  7. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse

    Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  8. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse

    Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

    Measured: From first purchase of study drug (Day 1) to Day 30

  9. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  10. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  11. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  12. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  13. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  14. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  15. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  16. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  17. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days

    Participants did not need to necessarily use the study medication for 10 consecutive days.

    Measured: From first purchase of study drug (Day 1) to Day 30

  18. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days

    Participants did not need to necessarily use the study medication for 10 consecutive days.

    Measured: From first purchase of study drug (Day 1) to Day 30

  19. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days

    Participants did not need to necessarily use the study medication for 10 consecutive days.

    Measured: From first purchase of study drug (Day 1) to Day 30

  20. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days

    Participants did not need to necessarily use the study medication for 10 consecutive days.

    Measured: From first purchase of study drug (Day 1) to Day 30

  21. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days

    Participants did not need to necessarily use the study medication for 7 consecutive days.

    Measured: From first purchase of study drug (Day 1) to Day 30

  22. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days

    Participants did not need to necessarily use the study medication for 7 consecutive days.

    Measured: From first purchase of study drug (Day 1) to Day 30

  23. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days

    Participants did not need to necessarily use the study medication for 7 consecutive days.

    Measured: From first purchase of study drug (Day 1) to Day 30

  24. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days

    Participants did not need to necessarily use the study medication for 7 consecutive days.

    Measured: From first purchase of study drug (Day 1) to Day 30

  25. Percentage of Participants in Data Analysis Set 1 Who Took More Than 2 Doses on a Calendar Day

    More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.

    Measured: From first purchase of study drug (Day 1) to Day 30

  26. Percentage of Participants in Data Analysis Set 2 Who Took More Than 2 Doses on a Calendar Day

    More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.

    Measured: From first purchase of study drug (Day 1) to Day 30

  27. Percentage of Participants in Data Analysis Set 3 Who Took More Than 2 Doses on a Calendar Day

    More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.

    Measured: From first purchase of study drug (Day 1) to Day 30

  28. Percentage of Participants in Data Analysis Set 4 Who Took More Than 2 Doses on a Calendar Day

    More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.

    Measured: From first purchase of study drug (Day 1) to Day 30

  29. Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  30. Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  31. Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  32. Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions

    Measured: From first purchase of study drug (Day 1) to Day 30

  33. Percentage of Participants in Data Analysis Set 1 Who Used the Product on More Than 10 Consecutive Calendar Days

    Measured: From first purchase of study drug (Day 1) to Day 30

  34. Percentage of Participants in Data Analysis Set 2 Who Used the Product on More Than 10 Consecutive Calendar Days

    Measured: From first purchase of study drug (Day 1) to Day 30

  35. Percentage of Participants in Data Analysis Set 3 Who Used the Product on More Than 10 Consecutive Calendar Days

    Measured: From first purchase of study drug (Day 1) to Day 30

  36. Percentage of Participants in Data Analysis Set 4 Who Used the Product on More Than 10 Consecutive Calendar Days

    Measured: From first purchase of study drug (Day 1) 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 posted26 Oct 2018
  2. Study start27 Dec 2018
  3. Primary completion28 Oct 2019
  4. Study completion28 Oct 2019

Why it stopped: Study was terminated on 18NOV2020 after an FDA meeting where it was determined no further actual use data was needed. There were no safety concerns.

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
Other
Allocation
Not applicable
Intervention model
Parallel groups
Model description
The Actual Use Trial (AUT) design utilizes a real world setting to assess the ability of consumers to use an investigational product that will be marketed in an over-the-counter setting according to the proposed product labelling. The primary objective of this AUT is to evaluate compliance with the labeled dosing directions for Advil 12 Hour and to understand why misuse occurred and if it was a conscious decision by the subject. A secondary objective is to evaluate the safety of Advil 12 Hour in unsupervised actual use and how it relates to misuse.
Masking
None (open label)
Enrolment
613 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03722238
Sponsor's protocol ID
B4371011
Other IDs
MARATHON AUT
Status last verified
Aug 2021
First submitted
25 Oct 2018
Last updated
24 Sep 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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 Pain, run by Pfizer at 27 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 8 inclusion and 18 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: stopped early, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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 24 Sep 2021). 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 in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period (time frame: From first purchase of study drug (Day 1) to Day 30). The study lists 4 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 NCT03722238.

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 24 Sep 2021.

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