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NCT02216357 · ClinicalTrials.gov registry record · Phase 2
Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease
A Phase 2 study, sponsored by Cumberland Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT02216357: Completed Phase 2 study, sponsored by Cumberland Pharmaceuticals.
NCT02216357 is a Phase 2 study that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02216357, a Phase 2 study, has completed, sponsored by Cumberland Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine the safety of oral ifetroban compared to placebo as measured by a \> 20% decrease in FEV1 compared to baseline following a dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin challenge.
Interventions
- DRUG Ifetroban, Oral Capsule
- DRUG Placebo, Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT02216357 record still lists
NCT02216357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Ifetroban, Oral Capsule is the first listed.
NCT02216357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02216357 about?
NCT02216357 is a clinical study titled "Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease". The primary objective of the study is to determine the safety of oral ifetroban compared to placebo as measured by a \> 20% decrease in FEV1 compared to baseline following a dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin challenge.
What is the current status of trial NCT02216357?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2014-08. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02216357?
The interventions under investigation include: Ifetroban, Oral Capsule (DRUG), Placebo, Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT02216357?
This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02216357's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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