Patient Compliance
Conditions
Keywords
ibuprofen 400 mg, actual use, compliance
Brief summary
This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in which subjects will use the product after making a purchase decision about ibuprofen 400 mg caplets based only on their reading of the Drug Facts Label (DFL) and other information on the package.
Interventions
DRUGIbuprofen 400 mg caplet
400 milligram (mg) caplet according to Drug Facts label
Sponsors
Pfizer
Study design
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female at least 18 years of age (19 years of age in Alabama) * Subject reports taking over-the-counter (OTC) analgesics for pain or fever relief
Exclusion criteria
* Current government-issued identification (ID) * Pregnant or breastfeeding females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study | Day 1 up to 30 days | Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (\>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study | Day1 up to 30 days | Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if the total number of dosing occasions (distinct usage date/time values from their diary) in which a participant received 2 or more caplets was 0, 1 or 2. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking no more than 1 caplet per dose, under the advice of a healthcare professional, based on the end of study follow up interview. |
Countries
United States
Participant flow
Pre-assignment details
Participants were screened by phone,then referred to their participating retail pharmacy site for scheduled face-to-face interview,after which they were given an empty ibuprofen 400 milligram (mg) caplet over-the-counter (OTC) package to review information on outside of entire package,then decision was made to purchase medicine by them.
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen All participants who purchased at least 1 carton of study medication. | 738 |
| Total | 738 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 31 |
| Overall Study | Other | 1 |
| Overall Study | Protocol Violation | 68 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Ibuprofen |
|---|---|
| Age, Continuous | 53.5 Years STANDARD_DEVIATION 13.7 |
| Sex: Female, Male Female | 412 Participants |
| Sex: Female, Male Male | 326 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 76 / 736 |
| serious Total, serious adverse events | 6 / 736 |
Outcome results
Primary
Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (\>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview.
Time frame: Day 1 up to 30 days
Population: Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibuprofen | Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study | 95.2 percentage of participants |
Secondary
Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if the total number of dosing occasions (distinct usage date/time values from their diary) in which a participant received 2 or more caplets was 0, 1 or 2. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking no more than 1 caplet per dose, under the advice of a healthcare professional, based on the end of study follow up interview.
Time frame: Day1 up to 30 days
Population: Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibuprofen | Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study | 84.4 percentage of participants |