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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 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 613 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03722238
The ClinicalTrials.gov registry entry for NCT03722238 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 613 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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