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To provide oral domperidone to patients between the ages of 18 and 60 years of age, according to the investigator's judgment, a prokinetic effect is needed for the relief of severe gastroparesis. We have defined severe gastroparesis as 1) positive gastric emptying scintigraphy (more than 10% residue at 4 hours), 2) nausea, 3) early satiety, 4) abdominal pain. We will recruit patients for two years and the patients will be given domperidone for up to two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Domperidone | Experimental | Participants will received domperidone at a dose of 10mg given up to three times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domperidone | Drug | oral tablet; dose is 10mg per tablet given up to 3 times daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Overall Symptoms Based on Likert Scale | A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'. | Baseline and End of study (2 years or last visit if patient withdraws) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Nausea Based on Likert Scale | A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'. | Baseline and End of study (2 years or last visit if patient withdraws) |
| Improvement of Vomiting Based on Likert Scale |
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Inclusion Criteria:
Male or Female
Age 18 - 60
Symptoms or manifestation secondary to gastroparesis such as vomiting, nausea, the feeling you are full after you start eating, and abdominal pain.
Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms which includes gastric emptying scintigraphy, esophagogastroduodenoscopy (EGD), and the patient's subjective symptoms.
Subject has signed informed consent for the administration of domperidone that informs the patient of potential adverse events
Female subjects must be:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Domperidone | Participants will received domperidone at a dose of 10mg given up to three times per day Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Domperidone | Participants will received domperidone at a dose of 10mg given up to three times per day Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Improvement of Overall Symptoms Based on Likert Scale | A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'. | Posted | Count of Participants | Participants | Baseline and End of study (2 years or last visit if patient withdraws) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Domperidone | Participants will received domperidone at a dose of 10mg given up to three times per day Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ron Schey | University of Iowa | 3193849756 | ron-schey@uiowa.edu |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'. |
| Baseline and End of study (2 years or last visit if patient withdraws) |
| Improvement of Abdominal Bloating or Distention Based on Likert Scale | A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'. | Baseline and End of study (2 years or last visit if patient withdraws) |
| Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale | A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'. | Baseline and End of study (2 years or last visit if patient withdraws) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Improvement of Nausea Based on Likert Scale | A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'. | Posted | Count of Participants | Participants | Baseline and End of study (2 years or last visit if patient withdraws) |
|
|
|
| Secondary | Improvement of Vomiting Based on Likert Scale | A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'. | Posted | Count of Participants | Participants | Baseline and End of study (2 years or last visit if patient withdraws) |
|
|
|
| Secondary | Improvement of Abdominal Bloating or Distention Based on Likert Scale | A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'. | Posted | Count of Participants | Participants | Baseline and End of study (2 years or last visit if patient withdraws) |
|
|
|
| Secondary | Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale | A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'. | Posted | Count of Participants | Participants | Baseline and End of study (2 years or last visit if patient withdraws) |
|
|
|
| 0 |
| 7 |
| 5 |
| 7 |
| Partial Bowel Obstruction | Gastrointestinal disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Heartburn | Gastrointestinal disorders |
|
| Hypophosphatemia | Blood and lymphatic system disorders |
|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders |
|
| Ruptured Right Ovarian Cyst | Reproductive system and breast disorders |
|
| Migraine | Nervous system disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Dizziness | Ear and labyrinth disorders |
|
| Shaking | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Chest Pain | Musculoskeletal and connective tissue disorders |
|
| Hand Tingling | Nervous system disorders |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders |
|
| Dry Mouth | General disorders |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders |
|
| Chest Palpitations | Cardiac disorders |
|
| Elevated ALT | Hepatobiliary disorders |
|
| Elevated AST | Hepatobiliary disorders |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |