At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 19 enrolled
Drug / intervention
Ifetroban, Oral Capsule +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease
In Brief
A Phase 2 clinical trial evaluating Ifetroban, Oral Capsule and Placebo, Oral Capsule for Aspirin Exacerbated Respiratory Disease (AERD). Completed, enrolled 19 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartAug 2014
First PostedAug 2014
Primary CompletionJan 2016
TodayJul 2026
First PostedAug 13, 2014
Enrollment StartAug 1, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.9 years ago
Interventions
Ifetroban, Oral Capsuledrug
Placebo, Oral Capsuledrug