GastroparesisPhase 2NCT00760461
Domperidone in Refractory Gastroparesis
A Phase 2 study testing Domperidone in people with Gastroparesis, run by Yale University at 1 site in United States.
Trial summary
The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy. 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
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18 and older
- Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
- Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
- Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
- Increased prolactin levels
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- Breast changes
- Extrapyramidal side effects
- Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)
Who cannot join
- History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
- Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females)
- Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
- Gastrointestinal hemorrhage or obstruction.
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Pregnant or breast feedings female.
- Known allergy to domperidone
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Digestive Diseases 40 Temple St, Suite 1A
New Haven, Connecticut, 06510
About this study
The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.
- Conditions
- Gastroparesis
- Being tested
- Domperidone
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneDrug
10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
| Study group | Role | What they receive |
|---|---|---|
| Domperidone | Other | Not described Receives: Drug: Domperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroparesis Cardinal Symptom Index
Measured: upon study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Enrolled subjects were unable to receive drug from dispensing pharmacy.
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 GastroparesisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anish A Sheth, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760461
- Sponsor's protocol ID
- 0809004202
- Status last verified
- Feb 2017
- First submitted
- 24 Sep 2008
- Last updated
- 18 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domperidone in Refractory Gastroparesis
- ClinicalTrials.gov ID
- NCT00760461
- Acronym / sponsor ID
- 0809004202
- Conditions
- Gastroparesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolled subjects were unable to receive drug from dispensing pharmacy.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Posted 18 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Domperidone | Other | Drug: Domperidone |
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 and older
- Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
- Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
- Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
Key exclusion criteria (7 listed)
- History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
- Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females)
- Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
- Gastrointestinal hemorrhage or obstruction.
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
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 |
|---|---|---|
| Domperidone10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily | Drug | Domperidone |
Primary outcome
Gastroparesis Cardinal Symptom Index
Time frame: upon study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anish A Sheth, MD principal investigator
Yale University
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 Domperidone in people with Gastroparesis, run by Yale University 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?
The sponsor lists 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Aug 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 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 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?
Yes. Results are posted in the registry (first posted 18 Aug 2017). 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?
Gastroparesis Cardinal Symptom Index (time frame: upon study completion). 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 18 Aug 2017.