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

Phase 3

Terminated

Conditions: Pain

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

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

Inclusion Criteria

Not provided

Exclusion Criteria

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
Community Clinical Pharmacy
🇺🇸
Mesa, Arizona, United States
ACACIA Apothecary and Wellness
🇺🇸
Tucson, Arizona, United States
Coconut Grove Pharmacy
🇺🇸
Miami, Florida, United States
Summerfield Pharmacy
🇺🇸
Riverview, 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
Scroll for more (17 remaining)
Mills Pharmacy at Bluff Park
🇺🇸Hoover, Alabama, United States