Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ibuprofen caplet · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Ibuprofen caplet arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ibuprofen 400 mg caplet | DRUG | 400 milligram (mg) caplet according to Drug Facts label |
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
Ibuprofen caplet is a small-molecule drug developed by Pfizer, Inc. (ticker PFE) as an ibuprofen 400 mg caplet. It is being studied in the therapeutic area of patient compliance, with the goal of supporting how patients take their medication as prescribed.
Ibuprofen caplet is being studied for patient compliance, meaning how reliably patients take medication as directed. The clinical program focuses on this use rather than on a specific disease indication, and the drug is not approved for this purpose based on available development information.
Ibuprofen caplet targets PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It acts as an inhibitor of these enzymes. This target class is consistent with the broader ibuprofen mechanism, and the drug is a small molecule.
Ibuprofen caplet is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with this specific 400 mg caplet formulation and its clinical development program in patient compliance.
Ibuprofen caplet is in Phase 3 development. It is investigational and is not approved for the patient compliance use studied in its clinical program. The Phase 3 trial has been completed, and no active trials are currently listed for this asset.
Ibuprofen caplet has been studied in one completed Phase 3 trial, NCT02294019, titled Actual Use Trial of Ibuprofen 400 mg. The trial enrolled 738 participants in the United States, included adults 18 years and older of all sexes, and was uncontrolled, non-randomized, and not double-blind.