Prolonged QTc IntervalPhase 4NCT01860703

Evaluation of Whether Deferiprone Affects QT Interval in Healthy Subjects

A Phase 4 study testing Deferiprone and moxifloxacin in people with Prolonged QTc Interval, run by ApoPharma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Randomized, single-dose, double-blind, placebo and active controlled, four-period crossover study to evaluate the effect of deferiprone on QTc prolongation after administration of a single therapeutic (33 mg/kg) and supratherapeutic(50 mg/kg) oral doses of deferiprone in healthy volunteers as compared to placebo… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Prolonged QTc Interval
What is being tested?: Deferiprone and moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Nov 2012to Jul 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Main Inclusion Criteria:

Healthy adult males or females, 18 - 45 years of age (inclusive).
Body weight ≥ 50 kg.
Body mass index (BMI) ≥ 19 and ≤ 32 kg/m2.
Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination).
Absolute neutrophil count (ANC) of >1.5x109/L.
12-lead ECGs which have no clinically significant findings as judged by the Principal Investigator (PI) or the PI's designee at screening and check-in of each study period,including:
Normal sinus rhythm (heart rate between 45 and 100 bpm);
QTcF interval ≤ 450 msec;
QRS interval ≤ 110 msec; and
PR interval ≤ 220 msec.
Subject must be capable of providing written informed consent, and must voluntarily consent to participate in the study.
Willing to answer inclusion and exclusion criteria questionnaire at check-in.

Main Exclusion Criteria:

History or presence of significant respiratory, cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, or psychiatric disease.
Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the PK of the investigational medicinal products (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections,acute inflammations, etc.).
Presence of liver impairment: aspartate aminotransferase (AST), alanine aminotransferase (ALT) above the normal reference range.
Presence of significant kidney impairment: serum creatinine higher than the normal reference range.
Allergy to band aids, adhesive dressing or medical tape.
Clinically significant history or presence of ECG abnormalities such as second- or third-degree atrioventricular block; evidence, or family history, of prolonged QT syndrome.
Sustained sitting systolic blood pressure of <90 mmHg or >140 mmHg, or diastolic blood pressure of >95 mmHg at screening or check-in of Period 1.
History or presence of hypersensitivity or idiosyncratic reaction to deferiprone, moxifloxacin, iron chelators, or quinolone antibiotics.
History or presence of:

agranulocytosis;
asthma;
chronic bronchitis;
diabetes;
migraine;
hypertension;
hypotension;
hypokalemia;
seizures or epilepsy;
anaemia.

History or presence of alcoholism or drug abuse within the past 2 years.
Used tobacco/nicotine-containing product for at least 3 months prior to the first dose of study.
Used Depo-Provera® or levonorgestrel implant within 90 days prior to the first dose and throughout the study.
Participation in another clinical trial within 28 days prior to the first dose of the study.
Had a clinically significant illness during the 4 weeks prior to check-in on Day -1 of Period 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Crossover, Thorough QT/QTc Trial to Evaluate the Potential of Deferiprone to Prolong the QT Interval in Healthy Subjects

Read the detailed description

Post-marketing study to evaluate the effect of deferiprone and deferiprone 3-O-glucuronide on QTc prolongation in healthy volunteers after administration of a single therapeutic (33 mg/kg) and supratherapeutic (50 mg/kg) oral dose of deferiprone and moxifloxacin (Avelox®).

Conditions: Prolonged QTc Interval
Being tested: Deferiprone, deferiprone matching placebo tablets, moxifloxacin, placebo
Keywords: Ferriprox®, LI, DFP, Deferiprone, Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DeferiproneDrug
Also called Ferriprox, L1
Ferriprox 500 mg tablets
deferiprone matching placebo tabletsDrug
Also called Placebo
deferiprone matching placebo tablets
moxifloxacinDrug
Also called Avelox
Active control
placeboDrug
moxifloxacin-matching placebo

Study groups in NCT01860703
Study group	Role	What they receive
Arm A - Maximum Therapeutic Dose	Experimental	Single dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets Receives: Drug: Deferiprone
Treatment Arm B - Supratherapeutic Dose	Experimental	Single dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets Receives: Drug: Deferiprone
Arm C - Placebo Control	Experimental	Single dose of matching deferiprone and moxifloxacin placebo tablets. Receives: Drug: deferiprone matching placebo tablets; Drug: placebo
Arm D - Positive Control	Experimental	Single dose of one 400 mg moxifloxacin tablet. Receives: Drug: moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone
Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.
ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Measured: 24-hour interval
Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone
Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.
ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Measured: 24-hour interval
Maximum Postdose QT/QTc Interval
The maximum post-dose QT/QTc interval for deferiprone and placebo.
ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Measured: 24-hour interval
Maximum Change From Baseline (dQT/dQTc)
Maximum Change From Baseline (dQT/dQTc) for deferiprone and placebo.
ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Measured: 24-hour interval

Secondary outcomes (6)

Number of Participants With Adverse Events
Number of participants with adverse events following therapeutic and supratherapeutic doses of deferiprone
Measured: From administration of the first dose until 7 days +/- 1 day following the final dose
Cmax of Deferiprone and Deferiprone 3-O Glucuronide
To evaluate the Cmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.
Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Measured: 24-hour interval
Tmax of Deferiprone and Deferiprone 3-O-glucuronide
To evaluate the Tmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.
Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Measured: 24-hour interval
AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide
AUC0-infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.
Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Measured: 24-hour interval
T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide
T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.
Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Measured: 24-hour interval
Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin
Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.
ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Measured: 24-hour interval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Jul 2013

First posted23 May 2013 (estimated)
Study startNov 2012
Primary completionDec 2012
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prolonged QTc IntervalStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01860703
Sponsor's protocol ID: LA37-1111
Status last verified: Nov 2014
First submitted: 6 May 2013
Last updated: 12 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Methadone Administration in Critically Ill Patients in the Intensive Care Unit and Risk of Prolonged QTc and Cardiac Arrythmia
Patients Treated With Methadone

All Prolonged QTc Interval trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Crossover, Thorough QT/QTc Trial to Evaluate the Potential of Deferiprone to Prolong the QT Interval in Healthy Subjects
ClinicalTrials.gov ID: NCT01860703
Acronym / sponsor ID: LA37-1111
Conditions: Prolonged QTc Interval
Keywords: Ferriprox®, LI, DFP, Deferiprone, Healthy Volunteers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: ApoPharmaIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Dec 2012 (actual)
Study completion: Jul 2013 (actual)
First posted: 23 May 2013 (estimated)
Results: Posted 12 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Arm A - Maximum Therapeutic Dose	Experimental	Drug: DeferiproneSingle dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets
Treatment Arm B - Supratherapeutic Dose	Experimental	Drug: DeferiproneSingle dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets
Arm C - Placebo Control	Experimental	Drug: deferiprone matching placebo tablets, Drug: placeboSingle dose of matching deferiprone and moxifloxacin placebo tablets.
Arm D - Positive Control	Experimental	Drug: moxifloxacinSingle dose of one 400 mg moxifloxacin tablet.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

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
DeferiproneAlso: Ferriprox, L1Ferriprox 500 mg tablets	Drug	Arm A - Maximum Therapeutic Dose, Treatment Arm B - Supratherapeutic Dose
deferiprone matching placebo tabletsAlso: Placebodeferiprone matching placebo tablets	Drug	Arm C - Placebo Control
moxifloxacinAlso: AveloxActive control	Drug	Arm D - Positive Control
placebomoxifloxacin-matching placebo	Drug	Arm C - Placebo Control

Primary outcome

Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone
Time frame: 24-hour interval
Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone
Time frame: 24-hour interval
Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Maximum Postdose QT/QTc Interval
Time frame: 24-hour interval
The maximum post-dose QT/QTc interval for deferiprone and placebo. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Maximum Change From Baseline (dQT/dQTc)
Time frame: 24-hour interval
Maximum Change From Baseline (dQT/dQTc) for deferiprone and placebo. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.

6 secondary outcomes

Number of Participants With Adverse Events
Time frame: From administration of the first dose until 7 days +/- 1 day following the final dose
Cmax of Deferiprone and Deferiprone 3-O Glucuronide
Time frame: 24-hour interval
Tmax of Deferiprone and Deferiprone 3-O-glucuronide
Time frame: 24-hour interval
AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time frame: 24-hour interval
T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time frame: 24-hour interval
Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin
Time frame: 24-hour interval

Results and safety

Results posted to the registry on 12 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABCD	13	11
BDAC	13	8
CADB	12	11
DCBA	12	10

Primary outcome: Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone

Time frame: 24-hour interval. Least squares mean (Standard Deviation). Unit: milliseconds

Measure	33 mg/kg Deferiprone n = 46	Placebo Control n = 45
Value	1.4 (4.92)	-1.6 (4.72)

33 mg/kg Deferiprone vs Placebo Control: Mean Difference (Final Values): 3.01 (90% CI 1.02 to 5.01)

Population analysed: Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).

Primary outcome: Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone

Time frame: 24-hour interval. Least squares mean (Standard Deviation). Unit: milliseconds

Measure	50 mg/kg Deferiprone n = 48	Placebo Control n = 45
Value	3.5 (5.28)	-1.7 (6.36)

50 mg/kg Deferiprone vs Placebo Control: Mean Difference (Final Values): 5.23 (90% CI 3.26 to 7.19)

Primary outcome: Maximum Postdose QT/QTc Interval

Time frame: 24-hour interval. Number. Unit: percentage of participants

Measure	Arm A - Maximum Therapeutic Dose n = 46	Arm B - Supratherapeutic Dose n = 48	Arm C - Placebo Control n = 45	Arm D - Positive Control n = 46
QTcF ≤ 450 msec	100	96	98	89
QTcF > 450 to ≤ 480 msec	0	4	2	11
QTcF > 480 to ≤ 500 msec	0	0	0	0
QTcF > 500 msec	0	0	0	0

Population analysed: The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).

Primary outcome: Maximum Change From Baseline (dQT/dQTc)

Time frame: 24-hour interval. Number. Unit: percentage of participants

Measure	Arm A - Maximum Therapeutic Dose n = 46	Arm B - Supratherapeutic Dose n = 48	Arm C - Placebo Control n = 45	Arm D - Positive Control n = 46
QTcF ≤ 30 msec	100	100	100	96
QTcF >30 but ≤ 60 msec	0	0	0	4
QTcF >60 msec	0	0	0	0

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of the first dose until 7 days (± 1 day) following the last study event of Period 4 or following early withdrawal.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm A - Maximum Therapeutic Dose	0 of 46 (0%)	12 of 46 (26.1%)	Not reported
Treatment Arm B - Supratherapeutic Dose	0 of 48 (0%)	35 of 48 (72.9%)	Not reported
Treatment Arm C - Placebo Control	0 of 45 (0%)	10 of 45 (22.2%)	Not reported
Treatment Arm D - Positive Control	0 of 46 (0%)	5 of 46 (10.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prolonged QTc Interval

Not yet recruitingObservational study
Methadone Administration in Critically Ill Patients in the Intensive Care Unit and Risk of Prolonged QTc and Cardiac Arrythmia
Patients Treated With Methadone

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.

Fernando Tricta, MD study chair

ApoPharma

Caroline Fradette, PhD study director

ApoPharma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Deferiprone and moxifloxacin in people with Prolonged QTc Interval, run by ApoPharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 12 Nov 2014. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone (time frame: 24-hour interval). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01860703.

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 12 Nov 2014.

Trial summary

Key requirements

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone

Primary outcome: Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone

Primary outcome: Maximum Postdose QT/QTc Interval

Primary outcome: Maximum Change From Baseline (dQT/dQTc)

Adverse events

Research links

Related trials for Prolonged QTc Interval

Methadone Administration in Critically Ill Patients in the Intensive Care Unit and Risk of Prolonged QTc and Cardiac Arrythmia

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone

Primary outcome: Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone

Primary outcome: Maximum Postdose QT/QTc Interval

Primary outcome: Maximum Change From Baseline (dQT/dQTc)

Adverse events