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NCT03722238 · ClinicalTrials.gov registry record · Phase 3
Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 613
- Enrollment target
NCT03722238: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT03722238 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 613 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03722238, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 613 participants
- Enrollment target
Study Summary
This will be an open-label, multicenter, 30-day, unsupervised AUS among targeted (at-risk) adult and adolescent consumers designed to mimic an OTC-like environment. More specifically, "at-risk" consumers, as discussed with the FDA, will comprise elderly consumers (\>65 years of age), consumers with an increased risk of gastrointestinal (GI) bleeding or cardiovascular (CV) adverse events, consumers who experience severe pain, low literacy subjects, and adolescents (12-17 years of age). The total number of subjects expected to enroll into the study is approximately 820. Sites will be pharmacies in diverse geographic locations around the US. Prospective adult subjects will be recruited via general population and targeted risk condition advertising (although participants will not be informed as to specific health conditions for which they are being recruited), while adolescents will be recruited using targeted, outbound pre-recruiting telephone calls. Subjects (or the parents/guardians of prospective adolescent subjects) responding to the advertisements or recruitment calls will be initially screened by telephone, and eligibility will subsequently be verified in-person at the pharmacy site.
Primary Outcome
Use period was defined as 30 days from purchase.
Interventions
- DRUG Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 613 participants |
| Start Date | 2018-12-27 |
| Est. Completion | 2019-10-28 |
| Phase | Phase 3 |
Why NCT03722238 stopped before completion
NCT03722238 is an interventional study that assigns participants to a tested intervention. The registered 613 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 1 intervention - of which Ibuprofen 600 mg Immediate Release/Extended Release Caplet is the first listed.
NCT03722238 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03722238 about?
NCT03722238 is a clinical study titled "Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers". This will be an open-label, multicenter, 30-day, unsupervised AUS among targeted (at-risk) adult and adolescent consumers designed to mimic an OTC-like environment. More specifically, "at-risk" consumers, as discussed with the FDA, will comprise elderly consumers (\>65 years of age), consumers with ...
What is the current status of trial NCT03722238?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 613 participants. The study started on 2018-12-27. Estimated completion is 2019-10-28.
What interventions are being tested in trial NCT03722238?
The interventions under investigation include: Ibuprofen 600 mg Immediate Release/Extended Release Caplet (DRUG).
Who is sponsoring clinical trial NCT03722238?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03722238's enrollment target sits among peer trials
613 598th of 2000 higher than 1,403 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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