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NCT02294019 · ClinicalTrials.gov registry record · Phase 3

Actual Use Trial of Ibuprofen 400 mg

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
738
Enrollment target

NCT02294019: Completed Phase 3 study, sponsored by Pfizer.

NCT02294019 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 738 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02294019, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
738 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DRUG Ibuprofen 400 mg caplet

Trial Details

FieldValue
Enrollment Target 738 participants
Start Date 2014-11
Est. Completion 2015-05
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT02294019 record still lists

NCT02294019 is an interventional study that assigns participants to a tested intervention. The registered 738 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Ibuprofen 400 mg caplet is the first listed.

NCT02294019 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02294019 about?

NCT02294019 is a clinical study titled "Actual Use Trial of Ibuprofen 400 mg". 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.

What is the current status of trial NCT02294019?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 738 participants. The study started on 2014-11. Estimated completion is 2015-05.

What interventions are being tested in trial NCT02294019?

The interventions under investigation include: Ibuprofen 400 mg caplet (DRUG).

Who is sponsoring clinical trial NCT02294019?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02294019's enrollment target sits among peer trials

738 479th of 2000 higher than 1,522 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02294019, the US trial registry maintained by the National Library of Medicine. NCT02294019 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.