Arrhythmias, CardiacNCT00925457
Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone
An observational study of Arrhythmias, Cardiac, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this retrospective observational study is to obtain information to confirm or contradict the results of prior studies on domperidone and sudden cardiac death. The population studied are the Saskatchewan residents who used domperidone or another type of medication known as a Proton Pump Inhibitor (PPI)… Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- Current Domperidone and Current proton pump inhibitor (PPI)
- How many people
- 1,608 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Mar 2009
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Saskachewan residents who received domperidone or a proton pump inhibitor (PPI) between January 1, 1990, and December 31, 2005
Who may be able to join
- Saskachewan residents who received domperidone or a proton pump inhibitor (PPI) between January 1, 1990, and December 31, 2005
Who cannot join
- Cancer free >=1 year of history in the database before receiving the first dose of domperidone or a PPI
About this study
The purpose of this retrospective observational study is to obtain information to confirm or contradict the results of prior studies on domperidone and sudden cardiac death. The population studied are the Saskatchewan residents who used domperidone or another type of medication known as a Proton Pump Inhibitor (PPI) between 1990 and 2005. Information will be collected from various sources including the Saskatchewan Health (SH) database and Cancer Registry.
Read the detailed description
The purpose of this population-based, observational study is to evaluate the combined risk of serious ventricular arrhythmia (irregular heart rhythm) and sudden cardiac death in users of domperidone (a medication used to treat certain gastrointestinal disorders) compared with users of proton pump inhibitors (another group of medications used to reduce gastric or stomach acid production. The study will be conducted using patient information from Saskatchewan Health (SH) who had recorded dispensings of domperidone or a PPI from 1990 through 2005. The first objective of the study is to estimate the combined relative risk of the occurrence of a particular type of irregular heart rhythm known as serious ventricular arrhythmia (SVA) and sudden cardiac death SCD (defined as a natural death from an unexpected circulatory arrest) during current use of domperidone or current use of proton pump inhibitors (PPIs) as compared with nonuse in a diabetic population. The second objective is to estimate the combined relative risk of SVA and SCD during current use of domperidone or current use of PPIs as compared with nonuse in a non-diabetic population. Study drug dosing information not required for Observational Study
- Conditions
- Arrhythmias, Cardiac
- Being tested
- No Intervention, Current Domperidone, Current proton pump inhibitor (PPI)
- Keywords
- Serious ventricular arrhythmia, Sudden cardiac death, Domperidone, Case-control study, Saskatchewan residents, Observational Study
- Medical subject headings
- Arrhythmias, Cardiac, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Neither current domperidone nor current PPI
Current DomperidoneDrug
Current domperidone at any dose, regardless of proton pump inhibitor status
Current proton pump inhibitor (PPI)Drug
Current PPI and not current dapoxetine
| Study group | Role | What they receive |
|---|---|---|
| 001 | Current Domperidone Current domperidone at any dose regardless of proton pump inhibitor status Receives: Drug: Current Domperidone | |
| 002 | Current proton pump inhibitor (PPI) Current PPI and not current dapoxetine Receives: Drug: Current proton pump inhibitor (PPI) | |
| 003 | No Intervention Neither current domperidone nor current PPI Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of serious ventricular arrhythmia and sudden cardiac death (combined end point)
Measured: Retrospective study
Secondary outcomes (1)
The second objective is to estimate the combined relative risk of SVA and SCD during current use of domperidone or current use of PPIs as compared with nonuse in a non-diabetic population.
Measured: Retrospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925457
- Sponsor's protocol ID
- CR016396
- Status last verified
- Jul 2016
- First submitted
- 18 Jun 2009
- Last updated
- 19 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone
- ClinicalTrials.gov ID
- NCT00925457
- Acronym / sponsor ID
- CR016396
- Conditions
- Arrhythmias, Cardiac
- Keywords
- Serious ventricular arrhythmia, Sudden cardiac death, Domperidone, Case-control study, Saskatchewan residents, Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,608 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Jun 2009 (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.
The purpose of this retrospective observational study is to obtain information to confirm or contradict the results of prior studies on domperidone and sudden cardiac death. The population studied are the Saskatchewan residents who used domperidone or another type of medication known as a Proton Pump Inhibitor (PPI) between 1990 and 2005. Information will be collected from various sources including the Saskatchewan Health (SH) database and Cancer Registry.
Detailed description
The purpose of this population-based, observational study is to evaluate the combined risk of serious ventricular arrhythmia (irregular heart rhythm) and sudden cardiac death in users of domperidone (a medication used to treat certain gastrointestinal disorders) compared with users of proton pump inhibitors (another group of medications used to reduce gastric or stomach acid production. The study will be conducted using patient information from Saskatchewan Health (SH) who had recorded dispensings of domperidone or a PPI from 1990 through 2005. The first objective of the study is to estimate the combined relative risk of the occurrence of a particular type of irregular heart rhythm known as serious ventricular arrhythmia (SVA) and sudden cardiac death SCD (defined as a natural death from an unexpected circulatory arrest) during current use of domperidone or current use of proton pump inhibitors (PPIs) as compared with nonuse in a diabetic population. The second objective is to estimate the combined relative risk of SVA and SCD during current use of domperidone or current use of PPIs as compared with nonuse in a non-diabetic population. Study drug dosing information not required for Observational Study
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: Current DomperidoneCurrent Domperidone Current domperidone at any dose regardless of proton pump inhibitor status |
| 002 | – | Drug: Current proton pump inhibitor (PPI)Current proton pump inhibitor (PPI) Current PPI and not current dapoxetine |
| 003 | – | Other: No InterventionNo Intervention Neither current domperidone nor current PPI |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Saskachewan residents who received domperidone or a proton pump inhibitor (PPI) between January 1, 1990, and December 31, 2005
Key inclusion criteria (1 listed)
- Saskachewan residents who received domperidone or a proton pump inhibitor (PPI) between January 1, 1990, and December 31, 2005
Key exclusion criteria (1 listed)
- Cancer free >=1 year of history in the database before receiving the first dose of domperidone or a PPI
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 |
|---|---|---|
| No InterventionNeither current domperidone nor current PPI | Other | 003 |
| Current DomperidoneCurrent domperidone at any dose, regardless of proton pump inhibitor status | Drug | 001 |
| Current proton pump inhibitor (PPI)Current PPI and not current dapoxetine | Drug | 002 |
Primary outcome
The occurrence of serious ventricular arrhythmia and sudden cardiac death (combined end point)
Time frame: Retrospective study
1 secondary outcome
The second objective is to estimate the combined relative risk of SVA and SCD during current use of domperidone or current use of PPIs as compared with nonuse in a non-diabetic population.
Time frame: Retrospective
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 19 Jul 2016.
- Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of DomperidoneLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 1 inclusion and 1 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 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The occurrence of serious ventricular arrhythmia and sudden cardiac death (combined end point) (time frame: Retrospective study). 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 19 Jul 2016.