Cardiac RepolarizationPhase 4NCT01819857
Droperidol and Cardiac Repolarization
A Phase 4 study testing Xomolix 0.625 mg intravenously, Xomolix 1.25 mg and Zofran 8 mg in people with Cardiac Repolarization, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
For many years droperidol has been used in prophylaxis and therapy of PONV. Information that it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those data didn't base on solid examinations confirming torsadogenic action of droperidol. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Cardiac Repolarization
- What is being tested?
- Xomolix 0.625 mg intravenously, Xomolix 1.25 mg and Zofran 8 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2011to Jul 2013
- Phase
- Phase 4
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- age 18-60 years
- sex: males
- ASA score I or II
Who cannot join
- treatment with drugs influencing cardiac repolarization
- coronary artery disease
- heart insufficiency NYHA>1
- serum electrolyte disturbances
- hypersensitivity to droperidol and/or ondansetron
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study.
For many years droperidol has been used in prophylaxis and therapy of PONV. Information that it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those data didn't base on solid examinations confirming torsadogenic action of droperidol. It is known that droperidol prolongs time of repolarisation, but there wasn't any data confirming its impact on transmural dispersion of repolarisation. Only estimation both of those actions in one time allows to define for sure arrhythmogenic role of droperidol.
The aim of this study was to answer the questions:
- Does droperidol make an significant prolongation of heart repolarisation, expressed as corrected QT interval?
- Does droperidol cause increase of transmural dispersion of repolarisation?
- Does possible torsadogenic acting of droperidol depend on dose of drug?
- Does ondansetron cause changes of electrical heart function, suggesting its possibilities to induce TdP tachycardia?
- What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in people not suffering from cardiovascular diseases?
- Conditions
- Cardiac Repolarization
- Being tested
- Xomolix 0.625 mg intravenously, Xomolix 1.25 mg, Zofran 8 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xomolix 0.625 mg intravenouslyDrug
intravenous administration of 0.625 mg droperidol
Xomolix 1.25 mgDrug
intravenous administration of 1.25 mg droperidol
Zofran 8 mgDrug
intravenous administration of 8 mg ondansetron
| Study group | Role | What they receive |
|---|---|---|
| Droperidol 0.625 mg intravenously | Active comparator | Not described Receives: Drug: Xomolix 0.625 mg intravenously |
| Droperidol 1.25 mg intravenously | Active comparator | Not described Receives: Drug: Xomolix 1.25 mg |
| Ondansetron 8 mg intravenously | Active comparator | Not described Receives: Drug: Zofran 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value
Measured: 20 minutes
Secondary outcomes (1)
Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startJun 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RepolarizationStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radoslaw Owczuk, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819857
- Sponsor's protocol ID
- RO4
- Other IDs
- MUG4
- Status last verified
- Aug 2013
- First submitted
- 9 Mar 2013
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study.
- ClinicalTrials.gov ID
- NCT01819857
- Acronym / sponsor ID
- RO4
- Conditions
- Cardiac Repolarization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Mar 2013 (estimated)
- 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.
For many years droperidol has been used in prophylaxis and therapy of PONV. Information that it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those data didn't base on solid examinations confirming torsadogenic action of droperidol. It is known that droperidol prolongs time of repolarisation, but there wasn't any data confirming its impact on transmural dispersion of repolarisation. Only estimation both of those actions in one time allows to define for sure arrhythmogenic role of droperidol.
The aim of this study was to answer the questions:
- Does droperidol make an significant prolongation of heart repolarisation, expressed as corrected QT interval?
- Does droperidol cause increase of transmural dispersion of repolarisation?
- Does possible torsadogenic acting of droperidol depend on dose of drug?
- Does ondansetron cause changes of electrical heart function, suggesting its possibilities to induce TdP tachycardia?
- What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in people not suffering from cardiovascular diseases?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Droperidol 0.625 mg intravenously | Active comparator | Drug: Xomolix 0.625 mg intravenously |
| Droperidol 1.25 mg intravenously | Active comparator | Drug: Xomolix 1.25 mg |
| Ondansetron 8 mg intravenously | Active comparator | Drug: Zofran 8 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-60 years
- sex: males
- ASA score I or II
Key exclusion criteria (5 listed)
- treatment with drugs influencing cardiac repolarization
- coronary artery disease
- heart insufficiency NYHA>1
- serum electrolyte disturbances
- hypersensitivity to droperidol and/or ondansetron
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 |
|---|---|---|
| Xomolix 0.625 mg intravenouslyintravenous administration of 0.625 mg droperidol | Drug | Droperidol 0.625 mg intravenously |
| Xomolix 1.25 mgintravenous administration of 1.25 mg droperidol | Drug | Droperidol 1.25 mg intravenously |
| Zofran 8 mgintravenous administration of 8 mg ondansetron | Drug | Ondansetron 8 mg intravenously |
Primary outcome
Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value
Time frame: 20 minutes
1 secondary outcome
Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms
Time frame: 20 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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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 4 study testing Xomolix 0.625 mg intravenously, Xomolix 1.25 mg and Zofran 8 mg in people with Cardiac Repolarization, run by Medical University of Gdansk at 1 site in Poland.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 7 Aug 2013. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value (time frame: 20 minutes). 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 7 Aug 2013.