Information:
Error:
ID
21145
Description
Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis; ODM derived from: https://clinicaltrials.gov/show/NCT00639808
Link
https://clinicaltrials.gov/show/NCT00639808
Keywords
Versions (1)
- 4/11/17 4/11/17 -
Uploaded on
April 11, 2017
DOI
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License
Creative Commons BY 4.0
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Eligibility Gastroparesis NCT00639808
Eligibility Gastroparesis NCT00639808
- StudyEvent: Eligibility
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Eligibility Gastroparesis NCT00639808
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Diabetes mellitus
Item
subject has type 1 or type 2 diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Gastroparesis
Item
subject has documented diagnosis of gastroparesis by:
boolean
C0152020 (UMLS CUI [1])
Delayed gastric emptying
Item
delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
boolean
C0740411 (UMLS CUI [1])
Chronic upper abdominal discomfort
Item
a minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
boolean
C1868919 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,2])
Endoscopy finding
Item
subject has normal upper endoscopy
boolean
C0438280 (UMLS CUI [1])
Gynaecological status
Item
if female, must be permanently sterilized or postmenopausal.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0015787 (UMLS CUI [2])
Experimental drugs
Item
patient has received any investigational drug within the preceding 30 days
boolean
C0304229 (UMLS CUI [1])
Pharmacotherapy affecting gastric motility
Item
patient is taking unstable doses of medication that affects gastric motility
boolean
C0013216 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0232572 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,2])
C0232572 (UMLS CUI [1,3])
Comorbidity
Item
patient has co-morbid condition
boolean
C0009488 (UMLS CUI [1])
Hepatitis B, hepatitis C, HIV
Item
patient has a positive laboratory test result for hepatitis b, hepatitis c, hiv, or controlled substances.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Psychiatric disorder
Item
patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
boolean
C0004936 (UMLS CUI [1])
Hypersensitivity to any drug
Item
patient has a recent,adult history of clinically significant hypersensitivity reaction(s) to any drug.
boolean
C0020517 (UMLS CUI [1,1])
C1254351 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,2])
Substance Use Disorder
Item
patient has known history of alcoholism
boolean
C0038586 (UMLS CUI [1])