GastroparesisPhase 3NCT01378884
The Use of Domperidone for Gastroparesis
A Phase 3 study testing Domperidone in people with Gastroparesis, run by Allegiance Health.
Trial summary
The purpose of this study is to determine whether domperidone can be used safely and effectively for patient with gastroparesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Domperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Mar 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18 or older
- Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
- Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
- Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:
- increased prolactin levels,
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- extrapyramidal side effects,
- breast changes,
- cardiac arrhythmias including QT prolongation, and
Who cannot join
- History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
- History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
- Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo-obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
- Pregnant or breast feeding female.
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- Known allergy to domperidone or any components of the domperidone formulation.
- Significantly significant electrolyte disorders.
- Gastrointestinal hemorrhage or obstruction.
About this study
Official title: Monitoring Study for the Use of Gastroparesis for Patient Who Have Failed Standard Therapy
The purpose of this study is to determine whether domperidone can be used safely and effectively for patient with gastroparesis.
Read the detailed description
Individuals who have been diagnosed with gastroparesis and have failed at least one standard therapy will be offered to trial domperidone as a possible remedy to their condition. Patients on the medication will be expected to to be followed by the physician at 3 months, 6 months 12months, and then annually while on the medication. Any change or significant adverse reaction to the medication or in their condition should be reported immediately to their physician.
- Conditions
- Gastroparesis
- Being tested
- Domperidone
- Keywords
- Gastroparesis, Domperidone, Motilium
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneDrug
Also called Domperidone / Motilium
Patient to receive treatment with Domperidone
| Study group | Role | What they receive |
|---|---|---|
| Domeperidone | Experimental | Patients to receive Domperidone for treatment of Gastroparesis Receives: Drug: Domperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Gastric motility
Patients will have improved gastric motility within three months of begining domperidone therpy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2012 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegiance Health
- Sponsor type
- University, hospital or other
- Investigators
- Ivan Cubas, MD, Principal investigator, Allegiance Health Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378884
- Sponsor's protocol ID
- AH 10-001
- Status last verified
- Mar 2013
- First submitted
- 3 Feb 2010
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Study for the Use of Gastroparesis for Patient Who Have Failed Standard Therapy
- ClinicalTrials.gov ID
- NCT01378884
- Acronym / sponsor ID
- AH 10-001
- Conditions
- Gastroparesis
- Keywords
- Gastroparesis, Domperidone, Motilium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allegiance HealthUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 23 Jun 2011 (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 study is to determine whether domperidone can be used safely and effectively for patient with gastroparesis.
Detailed description
Individuals who have been diagnosed with gastroparesis and have failed at least one standard therapy will be offered to trial domperidone as a possible remedy to their condition. Patients on the medication will be expected to to be followed by the physician at 3 months, 6 months 12months, and then annually while on the medication. Any change or significant adverse reaction to the medication or in their condition should be reported immediately to their physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Domeperidone | Experimental | Drug: DomperidonePatients to receive Domperidone for treatment of Gastroparesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female
- Age 18 or older
- Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
- Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
- Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:
Key exclusion criteria (9 listed)
- History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
- History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
- Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo-obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
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 |
|---|---|---|
| DomperidoneAlso: Domperidone / MotiliumPatient to receive treatment with Domperidone | Drug | Domeperidone |
Primary outcome
Improved Gastric motility
Time frame: 3 months
Patients will have improved gastric motility within three months of begining domperidone therpy
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 19 Mar 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.
Ivan Cubas, MD principal investigator
Allegiance Health Gastroenterology
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Domperidone in people with Gastroparesis, run by Allegiance Health.
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 9 inclusion and 9 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 19 Mar 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Improved Gastric motility (time frame: 3 months). 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 Mar 2013.