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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)

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ClinicalTrials.gov Identifier: NCT03153072
Recruitment Status : Withdrawn (decision of the investigator)
First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.


Condition or disease Intervention/treatment Phase
Supraventricular Tachycardia Biological: Assess the absorption of oral amiodarone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : September 6, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia [ Time Frame: 1 year ]


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Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03153072


Locations
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France
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03153072     History of Changes
Other Study ID Numbers: PI2016_843_0020
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors