Age | Pregnancy Absent | Breast Feeding Absent
Item
1. male subjects and non-pregnant, non-lactating female subjects between the ages of 18 and 75 years (inclusive)
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
2. willing and able to give written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Able to read English Language | Comprehension English Language
Item
3. ability to read and understand english
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
4. diagnosis of type 1 or type 2 diabetes
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Gastroparesis due to diabetes mellitus
Item
5. diagnosis of diabetic gastroparesis previously documented
boolean
C0267176 (UMLS CUI [1])
Gastroparesis Symptoms Index Score
Item
6. a mean daily gcsi-dd score of ≥2 and ≤4 for the 7 days prior to the randomization visit (visit 3, day 0)
boolean
C0152020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0918012 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
Childbearing Potential Contraceptive methods | Female Sterilization Absent | Postmenopausal state Absent | Contraceptives, Oral, Hormonal | Hormonal contraception Implantable | Hormonal contraception Injectables | Contraception, Barrier | Female Condoms | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal Spermicides | Intrauterine Devices | Partner had vasectomy
Item
7. female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from screening through the last dose of study drug: hormonal (oral, implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm, or cervical cap with spermicide), intrauterine device (iud), or vasectomized partner (6-months minimum)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0009907 (UMLS CUI [4])
C2985296 (UMLS CUI [5,1])
C0021102 (UMLS CUI [5,2])
C2985296 (UMLS CUI [6,1])
C0086466 (UMLS CUI [6,2])
C0004764 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
C0042241 (UMLS CUI [9])
C0493327 (UMLS CUI [10])
C0087145 (UMLS CUI [11])
C0021900 (UMLS CUI [12])
C0420842 (UMLS CUI [13])
Physical Examination | Medical History | Laboratory Results | Absence Abnormal Finding compromises Patient safety | Absence Abnormal Finding Impact Research results | Exception Abnormal lipid profile | Exception Glucose measurement Abnormal | Exception Hemoglobin A1c measurement Abnormal
Item
8. no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results (with the exception of lipid profile, glucose and hemoglobin a1c) during screening which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
boolean
C0031809 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C1254595 (UMLS CUI [3])
C0332197 (UMLS CUI [4,1])
C2826279 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C1113679 (UMLS CUI [4,4])
C0332197 (UMLS CUI [5,1])
C2826279 (UMLS CUI [5,2])
C4049986 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0740400 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0337438 (UMLS CUI [7,2])
C0205161 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0474680 (UMLS CUI [8,2])
C0205161 (UMLS CUI [8,3])
Therapeutic procedure Discontinue Diabetic gastroparesis
Item
9. willingness to discontinue current treatment for diabetic gastroparesis and to avoid all medications specified by the protocol for the duration of the study
boolean
C0087111 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0267176 (UMLS CUI [1,3])
Gastric Bypass | Partitioning of stomach using band | Pacemaker Gastric | Gastroparesis postoperative | Gastrointestinal motility disorder | Gastric ulcer | Duodenal Ulcer | Gastritis Severe | Stomach Carcinoma | Amyloidosis | Neuromuscular Diseases | Parkinson Disease | Collagen-vascular disease | Alcoholic Intoxication, Chronic | Uremia | Malnutrition | Hypothyroidism (if untreated)
Item
1. gastric bypass and gastric banding, gastric pacemakers, post-surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility such as active gastric ulcer, active duodenal ulcer, active severe gastritis, gastric cancer, amyloidosis, neuromuscular diseases (including parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, and untreated hypothyroidism
boolean
C0017125 (UMLS CUI [1])
C1960832 (UMLS CUI [2])
C0178611 (UMLS CUI [3,1])
C1704242 (UMLS CUI [3,2])
C0854519 (UMLS CUI [4])
C0854121 (UMLS CUI [5])
C0038358 (UMLS CUI [6])
C0013295 (UMLS CUI [7])
C0017152 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0699791 (UMLS CUI [9])
C0002726 (UMLS CUI [10])
C0027868 (UMLS CUI [11])
C0030567 (UMLS CUI [12])
C0262428 (UMLS CUI [13])
C0001973 (UMLS CUI [14])
C0041948 (UMLS CUI [15])
C0162429 (UMLS CUI [16])
C2749407 (UMLS CUI [17])
Metoclopramide allergy | Adverse reactions Metoclopramide | Dystonic reaction Metoclopramide | Tardive Dyskinesia Metoclopramide | Allergic Reaction Product Similar | Adverse reactions Product Similar | Dystonic reaction Product Similar | Tardive Dyskinesia Product Similar
Item
2. a history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia to metoclopramide or any comparable or similar product
boolean
C0570599 (UMLS CUI [1])
C0559546 (UMLS CUI [2,1])
C0025853 (UMLS CUI [2,2])
C0541919 (UMLS CUI [3,1])
C0025853 (UMLS CUI [3,2])
C0686347 (UMLS CUI [4,1])
C0025853 (UMLS CUI [4,2])
C1527304 (UMLS CUI [5,1])
C1514468 (UMLS CUI [5,2])
C2348205 (UMLS CUI [5,3])
C0559546 (UMLS CUI [6,1])
C1514468 (UMLS CUI [6,2])
C2348205 (UMLS CUI [6,3])
C0541919 (UMLS CUI [7,1])
C1514468 (UMLS CUI [7,2])
C2348205 (UMLS CUI [7,3])
C0686347 (UMLS CUI [8,1])
C1514468 (UMLS CUI [8,2])
C2348205 (UMLS CUI [8,3])
Tardive Dyskinesia | Physical findings Suggestive of Tardive Dyskinesia
Item
3. history of or physical findings suggestive of tardive dyskinesia
boolean
C0686347 (UMLS CUI [1])
C0311392 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0686347 (UMLS CUI [2,3])
Pharmaceutical Preparations Associated with Tardive Dyskinesia | Pharmaceutical Preparations Discontinue Unwilling | Pharmaceutical Preparations Discontinue Unable
Item
4. currently using and unwilling or unable to stop any medication known to be associated with tardive dyskinesia (see study reference manual) prior to washout (visit 2)
boolean
C0013227 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0686347 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Hypersensitivity Investigational New Drugs Ingredient | Metoclopramide allergy | Hypersensitivity Citric Acid | Hypersensitivity Sodium citrate | Hypersensitivity Benzalkonium Chloride | Hypersensitivity Edetic Acid | Hypersensitivity Sorbitol
Item
5. history of allergy to any of the ingredients in the study drug formulation; metoclopramide, citric acid, sodium citrate, benzalkonium chloride, edta, or sorbitol
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0570599 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0055819 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0142825 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0005026 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0013618 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0037688 (UMLS CUI [7,2])
Organ Transplantation | Pancreatitis, Chronic | Malabsorption Syndrome Gross | Celiac Disease | Inflammatory Bowel Diseases
Item
6. history of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease
boolean
C0029216 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
C0024523 (UMLS CUI [3,1])
C0439806 (UMLS CUI [3,2])
C0007570 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
Malignant Neoplasms | Exception Basal cell carcinoma | Recurrent Malignant Neoplasm
Item
7. malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of enrollment
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1458156 (UMLS CUI [3])
Kidney Disease | Liver disease | Nervous system disorder | Hematological Disease | Disease Oncologic | Lung disease | Mental disorder | Cardiovascular Disease | Communicable Disease | Condition compromises Patient safety | Condition Impact Validity Research results
Item
8. history of other clinically significant renal, hepatic, neurologic, hematologic, oncologic, pulmonary, psychiatric, cardiovascular or infectious disease, or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205478 (UMLS CUI [5,2])
C0024115 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0007222 (UMLS CUI [8])
C0009450 (UMLS CUI [9])
C0348080 (UMLS CUI [10,1])
C2945640 (UMLS CUI [10,2])
C1113679 (UMLS CUI [10,3])
C0348080 (UMLS CUI [11,1])
C4049986 (UMLS CUI [11,2])
C2349101 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
Renal dysfunction | Creatinine clearance measurement
Item
9. have renal dysfunction calculated as creatinine clearance (crcl) < 40 ml/min at screening (visit 1)
boolean
C3279454 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Glucohemoglobin measurement
Item
10. have a hemoglobin a1c > 12.5% at screening (visit 1)
boolean
C0202054 (UMLS CUI [1])
Pharmaceutical Preparations Unable to discontinue | Pharmaceutical Preparations Discontinue Unwilling | Metoclopramide Oral Product | Parenteral form metoclopramide | Domperidone | Tricyclic Antidepressive Agents | Macrolide Antibiotics | Prokinetic Agent | Cholinergic Agents | Anticholinergic Agents | Narcotic Analgesics | Agonist Oral | Antispasmodics | Dopamine Agonists | Monoamine Oxidase Inhibitors | Herbal supplement | Fiber products | Bulking preparation | Laxatives
Item
11. inability or unwillingness to stop using the following agents for 7 days during the washout period (day -7 to day -1) prior to randomization (visit 3, day 0) and refrain from their use for the 4-week study period; oral and parenteral formulations of metoclopramide, domperidone, tricyclic antidepressants, macrolide antibiotics, prokinetic agents, cholinergic agents, agents with significant anticholinergic effects, narcotic analgesics, orally administered β agonists, spasmolytics, dopamine agonists, monoamine oxidase inhibitors, herbal supplements, fiber or bulking products, and laxatives
boolean
C0013227 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0360083 (UMLS CUI [3])
C3217817 (UMLS CUI [4])
C0013015 (UMLS CUI [5])
C0003290 (UMLS CUI [6])
C0003240 (UMLS CUI [7])
C1268865 (UMLS CUI [8])
C0242893 (UMLS CUI [9])
C0242896 (UMLS CUI [10])
C0027409 (UMLS CUI [11])
C2987634 (UMLS CUI [12,1])
C1527415 (UMLS CUI [12,2])
C0037766 (UMLS CUI [13])
C0178601 (UMLS CUI [14])
C0026457 (UMLS CUI [15])
C1504473 (UMLS CUI [16])
C0225326 (UMLS CUI [17])
C1320234 (UMLS CUI [18])
C0282090 (UMLS CUI [19])
Neurotoxins Gastroparesis | Neurotoxins Delayed gastric emptying | Botulinum Toxin Type A | Botulinum toxin type B
Item
12. use of neurotoxins (e.g., botulinum type a or b) as a treatment for gastroparesis or delayed gastric emptying within 6 months of screening (visit 1)
boolean
C0027934 (UMLS CUI [1,1])
C0152020 (UMLS CUI [1,2])
C0027934 (UMLS CUI [2,1])
C0740411 (UMLS CUI [2,2])
C0006050 (UMLS CUI [3])
C0006051 (UMLS CUI [4])
Abnormal Finding | Prolonged QTc interval on electrocardiogram (ECG)
Item
13. clinically significant abnormal finding or a qtc interval >450 milliseconds (msec) on ecgs obtained at screening (visit 1) or pre- or post-dose at randomization (visit 3)
boolean
C2826279 (UMLS CUI [1])
C4015677 (UMLS CUI [2])
Pharmaceutical Preparations Associated with Torsades de Pointes | Pharmaceutical Preparations Unable to discontinue | Pharmaceutical Preparations Discontinue Unwilling | Prolonged QT interval
Item
14. inability or unwillingness to stop using medications associated with torsades de pointes or a prolonged qt interval for 30 days prior to the initial symptom assessment and refrain from their use for the 4-week study period (see study reference manual)
boolean
C0013227 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0151878 (UMLS CUI [4])
Pregnancy, Planned | Pregnancy | Breast Feeding
Item
15. female subjects who are trying to conceive, are pregnant, or are lactating
boolean
C0032992 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Childbearing Potential Serum pregnancy test (B-HCG) Positive | Childbearing Potential Urine hCG pregnancy test Positive
Item
16. positive serum human chorionic gonadotropin (hcg) pregnancy test at screening or a positive hcg urine test on day 0 prior to administration of study drug for women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C2188702 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Substance Use Disorders | Substance Dependence
Item
17. history of alcohol or drug abuse within the year prior to the screening visit, or current known evidence of substance dependence or abuse
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Therapy, Investigational
Item
18. participation in a clinical (investigational) trial or receipt of a non-fda approved therapy within 30 days prior to the screening visit (visit 1) with the exception of domperidone
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0949266 (UMLS CUI [3])