Pseudoephedrine 60 MG for Barotrauma

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Barotrauma+1 More
Pseudoephedrine 60 MG - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether the medication pseudoephedrine can help prevent a common complication of hyperbaric oxygen therapy called middle ear barotrauma.

Eligible Conditions
  • Barotrauma
  • Dysbarism

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 12 minutes

1 minute
Middle Ear barotrauma documentation based on otoscopy
Patient description of ear pain
12 minutes
Requirement of Oxymetalozine rescue for ear pain during Hyperbaric Therapy compression

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Pseudoephedrine Group
1 of 2
Placebo Group
1 of 2
Experimental Treatment
Non-Treatment Group

90 Total Participants · 2 Treatment Groups

Primary Treatment: Pseudoephedrine 60 MG · Has Placebo Group · Phase 4

Pseudoephedrine GroupExperimental Group · 2 Interventions: Pseudoephedrine 60 MG, Hyperbaric Oxygen Therapy · Intervention Types: Drug, Procedure
Placebo GroupPlaceboComparator Group · 2 Interventions: Placebo oral tablet, Hyperbaric Oxygen Therapy · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric Oxygen Therapy
2016
Completed Phase 4
~390

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 minutes

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
599 Previous Clinical Trials
332,625 Total Patients Enrolled
Siamak Moayedi, MDPrincipal Investigator - University of Maryland School of Medicine, Department of Emergency Medicine
Mercy Medical Center, St Paul Place Specialists Inc
University Of Maryland School Of Medicine (Medical School)
Thos Jefferson University Hospital (Residency)
1 Previous Clinical Trials
600 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Maryland100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Maryland Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%