GastroparesisNCT04996134
Domperidone Expanded Access Treatment Program
A study testing Domperidone Oral Product in people with Gastroparesis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Domperidone Oral Product
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteUnited 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 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Male or female
- Age 12 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
Who cannot join
- History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de 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).
- Hepatic dysfunction
- Renal insufficiency
- Clinically significant electrolyte disorders.
- Gastrointestinal hemorrhage or obstruction
Show all 9Show fewer
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Pregnant or breast feeding female
- Known allergy to domperidone
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
About this study
Official title: Domperidone Protocol - FDA Expanded Access Program
To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.
Read the detailed description
To provide oral domperidone to patients ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation in patients whom the potential benefit may outweigh the risk of cardiovascular adverse reactions including QT prolongation, Torsades de Pointes, and death.
- Conditions
- Gastroparesis
- Being tested
- Domperidone Oral Product
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domperidone Oral ProductDrug
10-30 mg of oral domperidone administered QID.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Bosco, MD, Principal investigator, Aurora BayCare Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996134
- Sponsor's protocol ID
- IRB00107013
- Other IDs
- 17-123 (16-817)
- Status last verified
- Jan 2026
- First submitted
- 3 Aug 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domperidone Protocol - FDA Expanded Access Program
- ClinicalTrials.gov ID
- NCT04996134
- Acronym / sponsor ID
- IRB00107013
- Conditions
- Gastroparesis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- First posted
- 9 Aug 2021 (actual)
- 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.
To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.
Detailed description
To provide oral domperidone to patients ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation in patients whom the potential benefit may outweigh the risk of cardiovascular adverse reactions including QT prolongation, Torsades de Pointes, and death.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- Age 12 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
Key exclusion criteria (9 listed)
- History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de 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).
- Hepatic dysfunction
- Renal insufficiency
- Clinically significant electrolyte disorders.
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 |
|---|---|---|
| Domperidone Oral Product10-30 mg of oral domperidone administered QID. | 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 21 Jan 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.
John Bosco, MD principal investigator
Aurora BayCare Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domperidone Oral Product in people with Gastroparesis, run by Wake Forest University Health Sciences 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 5 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: status not confirmed, as of the sponsor's last update on 21 Jan 2026. 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.
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 21 Jan 2026.