Gastroesophageal Reflux DiseaseNCT02227927
Treatment Use of Domperidone for Gastroparesis
A study testing Domperidone in people with Gastroesophageal Reflux Disease and GERD, run by Scott Gabbard, MD at 2 sites in United States.
Trial summary
Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation. This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, GERD, Gastroparesis
- What is being tested?
- Domperidone
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18 and 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.
- Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
- Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
- increased prolactin levels
Show all 10Show fewer
- extrapyramidal side effects
- breast changes
- cardiac arrhythmias including QT prolongation and death
- There is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum.
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.
- Gastrointestinal hemorrhage or obstruction
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Pregnant or breast feeding female
- Known allergy to domperidone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.
This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use.
Read the detailed description
The Treatment Use of Domperidone program is also available at the Cleveland Clinic Florida/Weston Gastroenterology Department. This is not a "traditional" research study, but an expanded use protocol for patients who may benefit from the drug. Because of this, this study is enrolling patients via invitation only, and as such, all expenses associated with the drug, initiation and follow up of treatment are the responsibility of the patient or the patient's third party payer.
- Conditions
- Gastroesophageal Reflux Disease, GERD, Gastroparesis
- Being tested
- Domperidone
- Keywords
- Gastroesophageal Reflux Disease, GERD, Gastroparesis, Domperidone
- Medical subject headings
- Gastroesophageal Reflux, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneDrug
10-30mg oral dose, four times daily.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Scott Gabbard, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Scott Gabbard, MD, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227927
- Sponsor's protocol ID
- CCF-Domperidone
- Other IDs
- CCF-Domperidone
- Status last verified
- Nov 2026
- First submitted
- 25 Aug 2014
- Last updated
- 6 Nov 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Use of Domperidone for Gastroparesis
- ClinicalTrials.gov ID
- NCT02227927
- Acronym / sponsor ID
- CCF-Domperidone
- Conditions
- Gastroesophageal Reflux Disease, GERD, Gastroparesis
- Keywords
- Gastroesophageal Reflux Disease, GERD, Gastroparesis, Domperidone
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Scott Gabbard, MDUniversity, hospital or other
- First posted
- 28 Aug 2014 (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.
Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.
This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use.
Detailed description
The Treatment Use of Domperidone program is also available at the Cleveland Clinic Florida/Weston Gastroenterology Department. This is not a "traditional" research study, but an expanded use protocol for patients who may benefit from the drug. Because of this, this study is enrolling patients via invitation only, and as such, all expenses associated with the drug, initiation and follow up of treatment are the responsibility of the patient or the patient's third party payer.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- Age 18 and 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.
- Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
- 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.
- 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 |
|---|---|---|
| Domperidone10-30mg oral dose, four times daily. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domperidone in people with Gastroesophageal Reflux Disease and GERD, run by Scott Gabbard, MD at 2 sites 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 10 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: status not confirmed, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
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.
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 6 Nov 2026.