CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 738 enrolled
Drug / intervention
Ibuprofen 400 mg capletdrug
Likely dose
Ibuprofen 400 mg capletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02294019
NCT02294019Phase 3Completed
CompareCT.gov

A Multicenter Actual Use And Compliance Study Of Ibuprofen 400 Mg In A Simulated Over-the-counter Environment

Pfizer·interventional·Posted Nov 19, 2014·Updated May 30, 2016

In Brief

A Phase 3 clinical trial evaluating Ibuprofen 400 mg caplet for Patient Compliance. Completed, enrolled 738 participants across 25 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPatient Compliance
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 19, 2014
Enrollment StartNov 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.6 years ago

Interventions

Ibuprofen 400 mg capletdrug

400 milligram (mg) caplet according to Drug Facts label