Evaluation of the Pharmacokinetic Profile, Pharmacodynamic Effects, Acceptability and Tolerability of an Oral Amiodarone Solution of 15 mg / mL in Children With Supra Ventricular Tachycardia (Enteramio)

The supra ventricular tachycardia is the most common symptomatic arrhythmia in pediatrics. Amiodarone is an antiarrhythmic drug used in this indication. Pharmacokinetic, efficacy and safety data are not known in the pediatric population due to the lack of a suitable specialty available on the market.

The development of an amiodarone oral solution formulation adapted to this age group should provide a therapeutic alternative and collect data on the pharmacokinetics, efficacy, acceptability and tolerability of the drug.

Study Overview

• Status: Withdrawn
• Conditions: Supraventricular Tachycardia
• Intervention / Treatment: Biological: Assess the absorption of oral amiodarone

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Child (boy or girl) with supra ventricular tachycardia diagnosed by ECG recording.
• Child aged 0 to 11 years.
• Child whose parents / legal representative (s) agree to sign a consent form.
• Child whose opinion / agreement has been / has been attempted to be collected.
• Child and parents / legal representative (s) being ready and able to participate in the study, understanding and committing to respect the procedures of the study throughout its duration.
• Child enrolled in a social security scheme.
• Child with a body mass index between the 3rd and the 97th percentile.

Exclusion Criteria:

• A child with a known hypersensitivity to the active ingredient, iodine or any of the excipients of the study formulation.
• Child who has already been treated with amiodarone (as a capsule or with the oral injectable form)
• Impossibility of taking blood samples.
• Hyperthyroidism (TSH <laboratory low standard).
• Disruption of liver function (ASAT> 3N and / or ALT> 3N).
• Renal impairment (Cl creat <30 mL / min)
• Hepatic insufficiency (TP or factor V <70%)
• Inotropic support.
• Uncorrected severe ionic disorders.
• Extension of the QTc space before the implementation of the treatment (> 450 ms).
• Non-paired sinus disease.
• Concomitant treatment with a drug which has an absolute contraindication with amiodarone.
• Child with gastrointestinal disorders such as malabsorption syndrome.
• Weight <2.5 kg.
• Child whose mother was treated with amiodarone during pregnancy.
• Child who received another product under investigation or participated in another study within 60 days of the start of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A child with supraventricular tachycardia	Biological: Assess the absorption of oral amiodarone; Evaluate the pharmacokinetics of oral amiodarone solution at 15 mg / mL after oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone
• Other Study ID Numbers: PI2016_843_0020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No