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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.

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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

FieldValue
Enrollment Target 19 participants
Start Date 2014-08
Est. Completion 2016-01
Phase Phase 2

Sponsor

Cumberland Pharmaceuticals

43 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.