ID

43043

Description

Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis; ODM derived from: https://clinicaltrials.gov/show/NCT00845858

Link

https://clinicaltrials.gov/show/NCT00845858

Keywords

Versions (2)
  1. 3/23/18 3/23/18 -
  2. 9/17/21 9/17/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Gastroparesis NCT00845858

English

Eligibility Gastroparesis NCT00845858

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male subjects and non-pregnant, non-lactating female subjects between the ages of 18 and 75 years (inclusive)
Description

Age | Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
2. willing and able to give written informed consent to participate in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
3. ability to read and understand english
Description

Able to read English Language | Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
4. diagnosis of type 1 or type 2 diabetes
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
5. diagnosis of diabetic gastroparesis previously documented
Description

Gastroparesis due to diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0267176
6. a mean daily gcsi-dd score of ≥2 and ≤4 for the 7 days prior to the randomization visit (visit 3, day 0)
Description

Gastroparesis Symptoms Index Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0152020
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0918012
UMLS CUI [1,4]
C0449820
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)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0015787
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0009907
UMLS CUI [5,1]
C2985296
UMLS CUI [5,2]
C0021102
UMLS CUI [6,1]
C2985296
UMLS CUI [6,2]
C0086466
UMLS CUI [7]
C0004764
UMLS CUI [8]
C0221829
UMLS CUI [9]
C0042241
UMLS CUI [10]
C0493327
UMLS CUI [11]
C0087145
UMLS CUI [12]
C0021900
UMLS CUI [13]
C0420842
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0262926
UMLS CUI [3]
C1254595
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C2826279
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C1113679
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C2826279
UMLS CUI [5,3]
C4049986
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0740400
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0337438
UMLS CUI [7,3]
C0205161
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0474680
UMLS CUI [8,3]
C0205161
9. willingness to discontinue current treatment for diabetic gastroparesis and to avoid all medications specified by the protocol for the duration of the study
Description

Therapeutic procedure Discontinue Diabetic gastroparesis

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0267176
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Description

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)

Data type

boolean

Alias
UMLS CUI [1]
C0017125
UMLS CUI [2]
C1960832
UMLS CUI [3,1]
C0178611
UMLS CUI [3,2]
C1704242
UMLS CUI [4]
C0854519
UMLS CUI [5]
C0854121
UMLS CUI [6]
C0038358
UMLS CUI [7]
C0013295
UMLS CUI [8,1]
C0017152
UMLS CUI [8,2]
C0205082
UMLS CUI [9]
C0699791
UMLS CUI [10]
C0002726
UMLS CUI [11]
C0027868
UMLS CUI [12]
C0030567
UMLS CUI [13]
C0262428
UMLS CUI [14]
C0001973
UMLS CUI [15]
C0041948
UMLS CUI [16]
C0162429
UMLS CUI [17]
C2749407
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0570599
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0025853
UMLS CUI [3,1]
C0541919
UMLS CUI [3,2]
C0025853
UMLS CUI [4,1]
C0686347
UMLS CUI [4,2]
C0025853
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C1514468
UMLS CUI [5,3]
C2348205
UMLS CUI [6,1]
C0559546
UMLS CUI [6,2]
C1514468
UMLS CUI [6,3]
C2348205
UMLS CUI [7,1]
C0541919
UMLS CUI [7,2]
C1514468
UMLS CUI [7,3]
C2348205
UMLS CUI [8,1]
C0686347
UMLS CUI [8,2]
C1514468
UMLS CUI [8,3]
C2348205
3. history of or physical findings suggestive of tardive dyskinesia
Description

Tardive Dyskinesia | Physical findings Suggestive of Tardive Dyskinesia

Data type

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C0686347
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)
Description

Pharmaceutical Preparations Associated with Tardive Dyskinesia | Pharmaceutical Preparations Discontinue Unwilling | Pharmaceutical Preparations Discontinue Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0686347
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1299582
5. history of allergy to any of the ingredients in the study drug formulation; metoclopramide, citric acid, sodium citrate, benzalkonium chloride, edta, or sorbitol
Description

Hypersensitivity Investigational New Drugs Ingredient | Metoclopramide allergy | Hypersensitivity Citric Acid | Hypersensitivity Sodium citrate | Hypersensitivity Benzalkonium Chloride | Hypersensitivity Edetic Acid | Hypersensitivity Sorbitol

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
UMLS CUI [2]
C0570599
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0055819
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0142825
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0005026
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0013618
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0037688
6. history of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease
Description

Organ Transplantation | Pancreatitis, Chronic | Malabsorption Syndrome Gross | Celiac Disease | Inflammatory Bowel Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2]
C0149521
UMLS CUI [3,1]
C0024523
UMLS CUI [3,2]
C0439806
UMLS CUI [4]
C0007570
UMLS CUI [5]
C0021390
7. malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of enrollment
Description

Malignant Neoplasms | Exception Basal cell carcinoma | Recurrent Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3]
C1458156
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0018939
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205478
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0004936
UMLS CUI [8]
C0007222
UMLS CUI [9]
C0009450
UMLS CUI [10,1]
C0348080
UMLS CUI [10,2]
C2945640
UMLS CUI [10,3]
C1113679
UMLS CUI [11,1]
C0348080
UMLS CUI [11,2]
C4049986
UMLS CUI [11,3]
C2349101
UMLS CUI [11,4]
C0683954
9. have renal dysfunction calculated as creatinine clearance (crcl) < 40 ml/min at screening (visit 1)
Description

Renal dysfunction | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0373595
10. have a hemoglobin a1c > 12.5% at screening (visit 1)
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1548265
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0360083
UMLS CUI [4]
C3217817
UMLS CUI [5]
C0013015
UMLS CUI [6]
C0003290
UMLS CUI [7]
C0003240
UMLS CUI [8]
C1268865
UMLS CUI [9]
C0242893
UMLS CUI [10]
C0242896
UMLS CUI [11]
C0027409
UMLS CUI [12,1]
C2987634
UMLS CUI [12,2]
C1527415
UMLS CUI [13]
C0037766
UMLS CUI [14]
C0178601
UMLS CUI [15]
C0026457
UMLS CUI [16]
C1504473
UMLS CUI [17]
C0225326
UMLS CUI [18]
C1320234
UMLS CUI [19]
C0282090
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)
Description

Neurotoxins Gastroparesis | Neurotoxins Delayed gastric emptying | Botulinum Toxin Type A | Botulinum toxin type B

Data type

boolean

Alias
UMLS CUI [1,1]
C0027934
UMLS CUI [1,2]
C0152020
UMLS CUI [2,1]
C0027934
UMLS CUI [2,2]
C0740411
UMLS CUI [3]
C0006050
UMLS CUI [4]
C0006051
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)
Description

Abnormal Finding | Prolonged QTc interval on electrocardiogram (ECG)

Data type

boolean

Alias
UMLS CUI [1]
C2826279
UMLS CUI [2]
C4015677
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)
Description

Pharmaceutical Preparations Associated with Torsades de Pointes | Pharmaceutical Preparations Unable to discontinue | Pharmaceutical Preparations Discontinue Unwilling | Prolonged QT interval

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0040479
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1548265
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0558080
UMLS CUI [4]
C0151878
15. female subjects who are trying to conceive, are pregnant, or are lactating
Description

Pregnancy, Planned | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032992
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
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
Description

Childbearing Potential Serum pregnancy test (B-HCG) Positive | Childbearing Potential Urine hCG pregnancy test Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C2188702
UMLS CUI [2,3]
C1514241
17. history of alcohol or drug abuse within the year prior to the screening visit, or current known evidence of substance dependence or abuse
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
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
Description

Study Subject Participation Status | Investigational New Drugs | Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0949266
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Similar models

Eligibility Gastroparesis NCT00845858

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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