CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 122 enrolled
Drug / intervention
Inhaled isopropyl alcohol +3 moredrug
Likely dose
Oral ondansetron 4 mgfrom 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.

Search/NCT02760069
NCT02760069Phase 4Completed
CompareCT.gov

Nasally Inhaled Isopropyl Alcohol Versus Oral Ondansetron for the Treatment of Nausea in the Emergency Department: A Double-Blind Randomized Controlled Trial

Brooke Army Medical Center·interventional·Posted May 3, 2016·Updated Jul 23, 2020

In Brief

A Phase 4 clinical trial evaluating Inhaled isopropyl alcohol, Oral ondansetron, and 2 other interventions for Nausea. Completed, enrolled 122 participants across 1 site.

Detailed Summary

This study will compare the efficacy of isopropyl alcohol and conventional anti-emetics with three study arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNausea
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 3, 2016
Enrollment StartJan 1, 2016
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.2 years ago

Interventions

Inhaled isopropyl alcoholdrug

Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.

Oral ondansetrondrug

Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.

Inhaled normal salinedrug

Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.

Oral placebodrug

Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00