Back to resultsEvaluation 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)
Primary Purpose
Supraventricular Tachycardia
Status
Withdrawn
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Assess the absorption of oral amiodarone
Sponsored by
About this trial
This is an interventional other trial for Supraventricular Tachycardia
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.
Sites / Locations
- CHU Amiens Picardie
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A child with supraventricular tachycardia
Arm Description
Outcomes
Primary Outcome Measures
Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia
Secondary Outcome Measures
Full Information
NCT ID
NCT03153072
First Posted
April 28, 2017
Last Updated
May 12, 2017
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03153072
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
decision of the investigator
Study Start Date
September 6, 2016 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A child with supraventricular tachycardia
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Assess the absorption of oral amiodarone
Intervention Description
Evaluate the pharmacokinetics of oral amiodarone solution at 15 mg / mL after oral administration
Primary Outcome Measure Information:
Title
Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia
Time Frame
1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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