A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine (Epinephrine)

September 12, 2011 updated by: Pakit Vichyanond, MD, Siriraj Hospital

Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection

This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI) may be more benefit such as intranasal route.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Facaulty of Medicine, Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy subjects
  2. 18-30 years-old

Exclusion Criteria:

  1. Pregnancy
  2. Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: epinephrine IN, epinephrine IM, saline IN
  1. Intranasal saline
  2. Intramuscular epinephrine
  3. Intranasal epinephrine
Drug: Epinephrine
  1. Intranasal epinephrine 5 mg /spray
  2. Intramuscular epinephrine 0.3 mg
  3. Intranasal saline spray
Other Names:
  • adrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Pharmacokinetics of epinephrine
Time Frame: predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose
Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route
predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of participants with adverse events as a measure of safety and tolerability
Time Frame: 1 year
Any side effects from such administration such as bad smelling, sorethroat.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Collaborators

Mahidol University

Investigators

  • Study Director: Pakit Vichyanond, MD., Siriraj medical school, Mahidol Univrsity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

September 12, 2011

First Posted (ESTIMATE)

September 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2011

Last Update Submitted That Met QC Criteria

September 12, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 078/2550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anaphylaxis

Clinical Trials on Epinephrine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe