Phase 3
Completed N=738
Actual Use Trial of Ibuprofen 400 mg
Patient Compliance
Source: ClinicalTrials.gov NCT02294019 ↗
Enrolled (actual)
738
Serious AEs
0.8%
Results posted
May 2016
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study |
95.2 | — |
| SECONDARY 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 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02294019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.