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Antihistamine

Diphenhydramine for Heat Stroke (BENEXE2022 Trial)

Phase 4

Waitlist Available

Led By Nicholas Ravanelli, PhD

Research Sponsored by Lakehead University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days

Awards & highlights

BENEXE2022 Trial Summary

This trial will investigate if taking antihistamine medication, like Benadryl®, can put people at increased risk of heat-related illness.

Eligible Conditions

Heat Stroke
Hyperhidrosis
Allergy or Hay Fever
Hyperthermia
Anticholinergic Syndrome

BENEXE2022 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sweating

Secondary outcome measures

Change in rectal temperature

BENEXE2022 Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention Order (Placebo - Diphenhydramine)Experimental Treatment2 Interventions

On separate days, participants will march on a treadmill for 60 minutes at a fixed rate of oxygen consumption (~1.75 liters of oxygen consumption per minute) in ~28°C and 30% relative humidity

Group II: Intervention Order (Diphenhydramine -Placebo)Experimental Treatment2 Interventions

On separate days, participants will march on a treadmill for 60 minutes at a fixed rate of oxygen consumption (~1.75 liters of oxygen consumption per minute) in ~28°C and 30% relative humidity

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diphenhydramine

2002

Completed Phase 4

~1170

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lakehead UniversityLead Sponsor

24 Previous Clinical Trials

3,973 Total Patients Enrolled

Nicholas Ravanelli, PhDPrincipal InvestigatorLakehead University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation include geriatric individuals?

"This clinical trial has set its age criteria as 18-49 years of age. For those under the legal age, 38 other studies are available while 101 trials have been tailored to elderly individuals that exceed 65 years old."

Answered by AI

Are there any eligibility criteria for participants of this investigation?

"Candidates with hyperthermia who are between 18 and 49 years of age may be accepted to this clinical trial. Currently, the study is inviting up to 20 participants."

Answered by AI

Are there any remaining slots available in this experiment for participants?

"Affirmative. Online records on clinicaltrials.gov verify that this research is still open for enrollment, with the initial posting occurring on November 1st 2022 and an edit made more recently on November 23rd 2022. The investigators are attempting to recruit 20 individuals from a single location."

Answered by AI

How would you rate the safety of this particular therapeutic approach?

"After assessing the safety of this treatment, our team at Power gave it a rating of 3. This is due to its status as an approved Phase 4 trial and previous clinical evidence in favor of its efficacy."

Answered by AI

What is the maximum capacity of participants in this clinical trial?

"Affirmative. The information hosted on clinicaltrials.gov indicates that this investigation is presently scouting for participants. This trial was initially publicly announced on November 1st 2022 and most recently amended on the 23rd of November, with a goal to recruit 20 individuals from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diphenhydramine and Sweating

2022. "Diphenhydramine and Sweating". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05586477.