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

NCT03722238 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: B4371011MARATHON AUT
• Study Type: interventional
• Target: 613
• Locations: 1 country
• Sites: 27

Brief 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 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

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (36)

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

Study Arms (1)

Ibuprofen 600 mg Immediate Release/Extended Release Tablets

EXPERIMENTAL

Ibuprofen 600 mg Immediate Release/Extended Release Tablets

Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet

Interventions

Ibuprofen 600 mg Immediate Release/Extended Release Caplet DRUG

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.

Ibuprofen 600 mg Immediate Release/Extended Release Tablets

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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).
• Has developmental or learning disabilities that, in the judgment of the parent/guardian or the investigator, would interfere with study participation.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (27)

Mills Pharmacy at Bluff Park

Hoover, Alabama, 35226, United States

Location

Community Clinical Pharmacy

Mesa, Arizona, 85202, United States

Location

ACACIA Apothecary and Wellness

Tucson, Arizona, 85704, United States

Location

Coconut Grove Pharmacy

Miami, Florida, 33133, United States

Location

Summerfield Pharmacy

Riverview, Florida, 33578, United States

Location

Huff's Drug Store

Ellijay, Georgia, 30540, United States

Location

Family Care Pharmacy

Highland, Illinois, 62249, United States

Location

Rice's Pharmacy

Beaver Dam, Kentucky, 42320, United States

Location

Catonsville Pharmacy

Catonsville, Maryland, 21228, United States

Location

Goodrich Pharmacy

Anoka, Minnesota, 55303, United States

Location

Kemper Corner Drug

Elk River, Minnesota, 55330, United States

Location

Cub Pharmacy #744

Rosemount, Minnesota, 55068, United States

Location

The Medicine Shoppe and Elsberry Pharmacy

Elsberry, Missouri, 63343, United States

Location

Albers Medical Pharmacy

Kansas City, Missouri, 64111, United States

Location

Countryside Pharmacy

Savannah, Missouri, 64485, United States

Location

Texas Road Pharmacy

Monroe, New Jersey, 08831, United States

Location

Dakota Pharmacy of Bismarck

Bismarck, North Dakota, 58501, United States

Location

Family Prescription Center

Bethlehem, Pennsylvania, 18015, United States

Location

RxXPress Health Mart Pharmacy

Grove City, Pennsylvania, 16127, United States

Location

Medical Center Compounding Pharmacy & Health Center

Cleveland, Tennessee, 37311, United States

Location

Buckeye Drugs

Lebanon, Tennessee, 37087, United States

Location

Summerwood Pharmacy and Compounding

Houston, Texas, 77044, United States

Location

The Medicine Shoppe #708

Sherman, Texas, 75092, United States

Location

BrickStreet Pharmacy

Tyler, Texas, 75701, United States

Location

Bountiful Drug

Bountiful, Utah, 84010, United States

Location

The Medicine Center

Salt Lake City, Utah, 84121, United States

Location

Montpelier Pharmacy, Inc.

Montpelier, Virginia, 23192, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

This study was terminated early due to recruitment problems and challenges. No safety concerns led to the decision to terminate.

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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: December 27, 2018
• Primary Completion: October 28, 2019
• Study Completion: October 28, 2019
• Last Updated: September 24, 2021
• Results First Posted: September 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

US (27)