Gastroesophageal Reflux, Gastroparesis
Conditions
Keywords
gastroparesis, gastroesophageal reflux
Brief summary
The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.
Detailed description
After heart or lung transplantation, the stomach tends to empty much slower than normal. This slow emptying is called gastroparesis. Gastroparesis is uncomfortable and often leads to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and an inability to take oral medications, contributing to complications of transplantation. Treatments for gastroparesis include both medical and surgical therapies that work for some but not all patients. Domperidone is a peripheral D2 antagonist that improves the emptying of the stomach in patients with gastroparesis. Domperidone is not FDA approved at this time. Some patients have developed lifethreatening abnormal heart rhythms after receiving domperidone intravenously. This problem has not been seen with domperidone given by mouth. We propose to administer domperidone by mouth at standard doses to solid organ transplant patients who have gastroparesis that is not responsive to standard medical therapies or who experience adverse drug side effects. This study will not be blinded (open-label) and has a single treatment arm (no control or placebo group).
Interventions
DRUGdomperidone
10mg orally four times per day
Sponsors
David J. Lederer, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* gastroparesis or gastroesophageal reflux that is refractory to standard therapy. * signed informed consent
Exclusion criteria
* serious cardiac arrhythmias * clinically significant bradycardia, sinus node dysfunction, or heart block. * prolonged QTc * clinically significant electrolyte disorders. * gastrointestinal hemorrhage or obstruction. * prolactinoma * pregnant or breast feeding female * known allergy to domperidone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Improvement | 2 months | The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Domperidone Arm Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with significant renal impairment will be 20mg twice a day.
domperidone: 10mg orally four times per day | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Domperidone Arm |
|---|---|
| Age, Customized 18-65 | 6 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Symptomatic Improvement
The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.
Time frame: 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Domperidone Arm | Symptomatic Improvement | 6 participants |