Supraventricular TachycardiaPhase 2EnteramioNCT03153072
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
A Phase 2 study testing Assess the absorption of oral amiodarone in people with Supraventricular Tachycardia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Supraventricular Tachycardia
- What is being tested?
- Assess the absorption of oral amiodarone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2016to 1 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Assess the absorption of oral amiodarone
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess the absorption of oral amiodaroneBiological
Evaluate the pharmacokinetics of oral amiodarone solution at 15 mg / mL after oral administration
| Study group | Role | What they receive |
|---|---|---|
| A child with supraventricular tachycardia | Other | Not described Receives: Biological: Assess the absorption of oral amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start6 Sep 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Why it stopped: decision of the investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153072
- Sponsor's protocol ID
- PI2016_843_0020
- Acronym
- Enteramio
- Status last verified
- May 2017
- First submitted
- 28 Apr 2017
- Last updated
- 15 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03153072
- Acronym / sponsor ID
- Enteramio / PI2016_843_0020
- Conditions
- Supraventricular Tachycardia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: decision of the investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A child with supraventricular tachycardia | Other | Biological: Assess the absorption of oral amiodarone |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assess the absorption of oral amiodaroneEvaluate the pharmacokinetics of oral amiodarone solution at 15 mg / mL after oral administration | Biological | A child with supraventricular tachycardia |
Primary outcome
Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Assess the absorption of oral amiodarone in people with Supraventricular Tachycardia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood analysis of the absorption of oral amiodarone solution in a child with supraventricular tachycardia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.