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

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ClinicalTrials.gov Identifier: NCT01432522
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : September 13, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Anaphylaxis Drug: Epinephrine

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection
Study Start Date : July 2010
Primary Completion Date : August 2011
Study Completion Date : September 2011


Arms and Interventions

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 Name: adrenaline


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432522


Locations
Thailand
Facaulty of Medicine, Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Siriraj Hospital
Mahidol University
Investigators
Study Director: Pakit Vichyanond, MD. Siriraj medical school, Mahidol Univrsity
More Information

Publications:
Responsible Party: Pakit Vichyanond, MD, Professor of Pediatrics, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01432522     History of Changes
Other Study ID Numbers: 078/2550
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Pakit Vichyanond, MD, Siriraj Hospital:
Intranasal epinephrine
Plasma epinephrine level

Additional relevant MeSH terms:
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents