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

Supraventricular Tachycardia Clinical Trial

— Enteramio  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03153072
• Other study ID #: PI2016_843_0020
• Status: Withdrawn
• Phase: Phase 2
• First received: April 28, 2017
• Last updated: May 12, 2017
• Start date: September 6, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: May 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular

Intervention

Biological:
• Assess the absorption of oral amiodarone
Evaluate the pharmacokinetics of oral amiodarone solution at 15 mg / mL after oral administration

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia		1 year