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

NCT ID: NCT03153072

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-06
• Study Completion Date: 2017-03-01

Brief Summary

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.

Conditions

Supraventricular Tachycardia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A child with supraventricular tachycardia

Group Type: OTHER

Assess the absorption of oral amiodarone

Intervention Type: BIOLOGICAL

Evaluate the pharmacokinetics of oral amiodarone solution at 15 mg / mL after oral administration

Interventions

Assess the absorption of oral amiodarone

Evaluate the pharmacokinetics of oral amiodarone solution at 15 mg / mL after oral administration

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Countries

France

Other Identifiers

PI2016_843_0020

Identifier Type: -

Identifier Source: org_study_id