Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers
- Conditions
- Pain
- Interventions
- Registration Number
- NCT03722238
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 613
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ibuprofen 600 mg Immediate Release/Extended Release Tablets Ibuprofen 600 mg Immediate Release/Extended Release Caplet Ibuprofen 600 mg Immediate Release/Extended Release Tablets
- Primary Outcome Measures
Name Time Method 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 From first purchase of study drug (Day 1) to Day 30 Use period was defined as 30 days from purchase.
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 From first purchase of study drug (Day 1) to Day 30 Use period was defined as 30 days from purchase.
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 From first purchase of study drug (Day 1) to Day 30 Use period was defined as 30 days from purchase.
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 From first purchase of study drug (Day 1) to Day 30 Use period was defined as 30 days from purchase.
- Secondary Outcome Measures
Name Time Method 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 From first purchase of study drug (Day 1) to Day 30 Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions From first purchase of study drug (Day 1) to Day 30 Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions From first purchase of study drug (Day 1) to Day 30 Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions 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 10 or More Calendar Days From first purchase of study drug (Day 1) to Day 30 Participants did not need to necessarily use the study medication for 10 consecutive days.
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 Use period was defined as 30 days from purchase.
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 Use period was defined as 30 days from purchase.
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 Use period was defined as 30 days from purchase.
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 Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions From first purchase of study drug (Day 1) to Day 30 Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions 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 Use Period Due to Unintentional Misuse From first purchase of study drug (Day 1) to Day 30 Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days From first purchase of study drug (Day 1) to Day 30 Participants did not need to necessarily use the study medication for 7 consecutive days.
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days From first purchase of study drug (Day 1) to Day 30 Participants did not need to necessarily use the study medication for 7 consecutive days.
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 Use period was defined as 30 days from purchase.
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 From first purchase of study drug (Day 1) to Day 30 Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions From first purchase of study drug (Day 1) to Day 30 Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions From first purchase of study drug (Day 1) to Day 30 Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions 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 10 or More Calendar Days From first purchase of study drug (Day 1) to Day 30 Participants did not need to necessarily use the study medication for 10 consecutive days.
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days From first purchase of study drug (Day 1) to Day 30 Participants did not need to necessarily use the study medication for 7 consecutive days.
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 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 10 or More Calendar Days From first purchase of study drug (Day 1) to Day 30 Participants did not need to necessarily use the study medication for 10 consecutive days.
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days From first purchase of study drug (Day 1) to Day 30 Participants did not need to necessarily use the study medication for 7 consecutive days.
Percentage of Participants in Data Analysis Set 1 Who Took More Than 2 Doses on a Calendar Day From first purchase of study drug (Day 1) to Day 30 More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
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 From first purchase of study drug (Day 1) to Day 30 Percentage of Participants in Data Analysis Set 4 Who Used the Product on More Than 10 Consecutive Calendar Days 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 10 or More Calendar Days From first purchase of study drug (Day 1) to Day 30 Participants did not need to necessarily use the study medication for 10 consecutive days.
Percentage of Participants in Data Analysis Set 2 Who Took More Than 2 Doses on a Calendar Day From first purchase of study drug (Day 1) to Day 30 More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
Percentage of Participants in Data Analysis Set 3 Who Took More Than 2 Doses on a Calendar Day From first purchase of study drug (Day 1) to Day 30 More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
Percentage of Participants in Data Analysis Set 2 Who Used the Product on More Than 10 Consecutive Calendar Days From first purchase of study drug (Day 1) to Day 30 Percentage of Participants in Data Analysis Set 4 Who Took More Than 2 Doses on a Calendar Day From first purchase of study drug (Day 1) to Day 30 More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
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 From first purchase of study drug (Day 1) to Day 30 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 From first purchase of study drug (Day 1) to Day 30 Percentage of Participants in Data Analysis Set 3 Who Used the Product on More Than 10 Consecutive Calendar Days From first purchase of study drug (Day 1) to Day 30 Percentage of Participants in Data Analysis Set 1 Who Used the Product on More Than 10 Consecutive Calendar Days From first purchase of study drug (Day 1) to Day 30
Trial Locations
- Locations (27)
Mills Pharmacy at Bluff Park
🇺🇸Hoover, Alabama, United States
ACACIA Apothecary and Wellness
🇺🇸Tucson, Arizona, United States
Summerfield Pharmacy
🇺🇸Riverview, Florida, United States
Coconut Grove Pharmacy
🇺🇸Miami, Florida, United States
Huff's Drug Store
🇺🇸Ellijay, Georgia, United States
Family Care Pharmacy
🇺🇸Highland, Illinois, United States
Rice's Pharmacy
🇺🇸Beaver Dam, Kentucky, United States
Catonsville Pharmacy
🇺🇸Catonsville, Maryland, United States
Goodrich Pharmacy
🇺🇸Anoka, Minnesota, United States
Kemper Corner Drug
🇺🇸Elk River, Minnesota, United States
Texas Road Pharmacy
🇺🇸Monroe, New Jersey, United States
Countryside Pharmacy
🇺🇸Savannah, Missouri, United States
The Medicine Shoppe and Elsberry Pharmacy
🇺🇸Elsberry, Missouri, United States
Albers Medical Pharmacy
🇺🇸Kansas City, Missouri, United States
Family Prescription Center
🇺🇸Bethlehem, Pennsylvania, United States
RxXPress Health Mart Pharmacy
🇺🇸Grove City, Pennsylvania, United States
Summerwood Pharmacy and Compounding
🇺🇸Houston, Texas, United States
BrickStreet Pharmacy
🇺🇸Tyler, Texas, United States
The Medicine Shoppe #708
🇺🇸Sherman, Texas, United States
Bountiful Drug
🇺🇸Bountiful, Utah, United States
Montpelier Pharmacy, Inc.
🇺🇸Montpelier, Virginia, United States
The Medicine Center
🇺🇸Salt Lake City, Utah, United States
Dakota Pharmacy of Bismarck
🇺🇸Bismarck, North Dakota, United States
Buckeye Drugs
🇺🇸Lebanon, Tennessee, United States
Medical Center Compounding Pharmacy & Health Center
🇺🇸Cleveland, Tennessee, United States
Cub Pharmacy #744
🇺🇸Rosemount, Minnesota, United States
Community Clinical Pharmacy
🇺🇸Mesa, Arizona, United States