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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 is a Phase 2 study that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 19 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02216357
The ClinicalTrials.gov registry entry for NCT02216357 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cumberland Pharmaceuticals, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ifetroban, Oral Capsule is the first listed.
NCT02216357 reports 0 study locations.
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.
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