ID

37222

Description

Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02382198

Link

https://clinicaltrials.gov/show/NCT02382198

Keywords

Versions (1)
  1. 7/8/19 7/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 8, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Sialorrhea NCT02382198

English

Eligibility Sialorrhea NCT02382198

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Sialorrhea NCT02382198
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pd as defined by united kingdom pd society brain bank criteria12
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
moderate-to-severe sialorrhea defined by a score in the item 2.2 of the mds-updrs greater than 2.
Description

Sialorrhea Moderate MDS-UPDRS | Sialorrhea Severe MDS-UPDRS

Data type

boolean

Alias
UMLS CUI [1,1]
C0037036
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C3639714
UMLS CUI [2,1]
C0037036
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C3639714
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. other idiopathic parkinsonian syndromes, e.g., progressive supranuclear palsy, cortico-basal syndrome, or multiple system atrophy
Description

Parkinsonian Disorders idiopathic | Progressive supranuclear palsy | Corticobasal degeneration | Multiple System Atrophy

Data type

boolean

Alias
UMLS CUI [1,1]
C0242422
UMLS CUI [1,2]
C0332240
UMLS CUI [2]
C0038868
UMLS CUI [3]
C0393570
UMLS CUI [4]
C0393571
2. secondary parkinsonian syndromes (drug-induced, traumatic, encephalitic or vascular)
Description

Parkinsonian Disorders Secondary | Parkinsonism due to drug | Parkinsonian Disorders Traumatic | Parkinson Disease, Postencephalitic | Parkinson Disease, Secondary Vascular

Data type

boolean

Alias
UMLS CUI [1,1]
C0242422
UMLS CUI [1,2]
C0175668
UMLS CUI [2]
C0270729
UMLS CUI [3,1]
C0242422
UMLS CUI [3,2]
C0332663
UMLS CUI [4]
C0030568
UMLS CUI [5]
C0751414
3. change in antiparkinsonian medication one month prior to enrolment
Description

Antiparkinson Agents Change

Data type

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0392747
4. prior use of glycopyrrolate with or without known hypersensitivity will be considered an exclusion criterion, as it increases the risk of unblinding due to prior knowledge of potential side effects or therapeutic benefit
Description

Glycopyrrolate | Hypersensitivity Glycopyrrolate

Data type

boolean

Alias
UMLS CUI [1]
C0017970
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0017970
5. change in the dose one month prior to enrolment of other anticholinergic agents or other drugs potentially affecting saliva production, such as tricyclic antidepressants, mao-a inhibitors, neuroleptics (including clozapine and quetiapine more frequently used in pd) or hypnotics. these mediation will remain in a constant dose throughout the trial;
Description

Anticholinergic Agents Dose Change | Pharmaceutical Preparations Dose Change | Pharmaceutical Preparations Affecting Saliva production | Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors | Antipsychotic Agents | Clozapine | quetiapine | Hypnotics | Pharmaceutical Preparations Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0242896
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0392747
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1821986
UMLS CUI [4]
C0003290
UMLS CUI [5]
C0026457
UMLS CUI [6]
C0040615
UMLS CUI [7]
C0009079
UMLS CUI [8]
C0123091
UMLS CUI [9]
C0020591
UMLS CUI [10,1]
C0013227
UMLS CUI [10,2]
C0178602
UMLS CUI [10,3]
C0205360
6. concomitant use of solid oral dosage forms of potassium chloride;
Description

Potassium Chloride Oral Product

Data type

boolean

Alias
UMLS CUI [1]
C3214855
7. pregnancy, breastfeeding, and premenopausal females or males not using adequate contraception; medically acceptable birth control methods for this study include: (1) abstinence (no sexual intercourse); (2) intrauterine device (iud); (3) diaphragm with spermicide; (4) condom with spermicide; and (5) oral contraceptives (birth control pills) + condom/diaphragm with spermicide.
Description

Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Absent | Gender Contraceptive methods Absent | Sexual Abstinence | Intrauterine Devices | Vaginal contraceptive diaphragm | Spermatocidal Agents | Condoms | Contraceptives, Oral

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0037862
UMLS CUI [9]
C0677582
UMLS CUI [10]
C0009905
8. moderate-to-severe constipation in spite of optimal treatment (mds-updrs, item 1.11>2);
Description

Constipation, moderate to severe | Therapy Optimal | MDS-UPDRS

Data type

boolean

Alias
UMLS CUI [1]
C3550392
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2698651
UMLS CUI [3]
C3639714
9. conditions that preclude anticholinergic therapy, e.g., documented history or symptoms suggestive of inflammatory bowel disease, glaucoma, myasthenia gravis, prostatic hypertrophy or obstructive urinary symptoms;
Description

Condition Excludes Anticholinergic Agents | Inflammatory Bowel Diseases | Symptoms Suggestive of Inflammatory Bowel Diseases | Glaucoma | Myasthenia Gravis | Prostatic Hypertrophy | URINARY OBSTRUCTIVE SYMPTOMS

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0242896
UMLS CUI [2]
C0021390
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0332299
UMLS CUI [3,3]
C0021390
UMLS CUI [4]
C0017601
UMLS CUI [5]
C0026896
UMLS CUI [6]
C1739363
UMLS CUI [7]
C0749941
10. conditions that can be exacerbated by anticholinergic effects of glycopyrrolate, e.g., documented history or symptoms suggestive of congestive heart failure, coronary heart disease, gastro-esophageal reflux disease or hyperthyroidism;
Description

Exacerbation Due to Glycopyrrolate | Congestive heart failure | Symptoms Suggestive of Congestive heart failure | Coronary heart disease | Gastroesophageal reflux disease | Hyperthyroidism

Data type

boolean

Alias
UMLS CUI [1,1]
C4086268
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0017970
UMLS CUI [2]
C0018802
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0332299
UMLS CUI [3,3]
C0018802
UMLS CUI [4]
C0010068
UMLS CUI [5]
C0017168
UMLS CUI [6]
C0020550
11. uncontrolled arterial hypertension (tas>140 mmhg or tad>90 mmhg, using an electronic sphygmomanometer and standardized procedure16);
Description

Hypertensive disease Uncontrolled | Systolic Pressure | Diastolic blood pressure | Use of Electronic sphygmomanometer

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C1524063
UMLS CUI [4,2]
C0183429
12. tachyarrhythmia (interval rr <0.6 sec.);
Description

Tachyarrhythmia | RR Interval Single Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0080203
UMLS CUI [2]
C3897782
13. tsh<0.4 miu/l;
Description

Thyroid stimulating hormone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202230
14. liver dysfunction (ast, alt, alp >2xupper normal limit);
Description

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151849
15. renal dysfunction (creatinine clearance <50 ml/min), as glycopyrrolate has predominant renal clearance;
Description

Renal dysfunction | Creatinine clearance measurement | Glycopyrrolate Renal clearance predominant

Data type

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0373595
UMLS CUI [3,1]
C0017970
UMLS CUI [3,2]
C0232813
UMLS CUI [3,3]
C1542147
16. inability or unwillingness of subject or legal guardian/representative to give written informed consent;
Description

Informed Consent Unable | Informed Consent Guardian Unable | Informed Consent Patient Representative Unable | Informed Consent Unwilling | Informed Consent Guardian Unwilling | Informed Consent Patient Representative Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030701
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0558080
UMLS CUI [5,1]
C0021430
UMLS CUI [5,2]
C1274041
UMLS CUI [5,3]
C0558080
UMLS CUI [6,1]
C0021430
UMLS CUI [6,2]
C0030701
UMLS CUI [6,3]
C0558080
17. participation in another investigational study at the time of recruitment or during the prior month.
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
Back to the top of the page

Similar models

Eligibility Sialorrhea NCT02382198

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Sialorrhea NCT02382198
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
pd as defined by united kingdom pd society brain bank criteria12
boolean
C0030567 (UMLS CUI [1])
Sialorrhea Moderate MDS-UPDRS | Sialorrhea Severe MDS-UPDRS
Item
moderate-to-severe sialorrhea defined by a score in the item 2.2 of the mds-updrs greater than 2.
boolean
C0037036 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3639714 (UMLS CUI [1,3])
C0037036 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C3639714 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Parkinsonian Disorders idiopathic | Progressive supranuclear palsy | Corticobasal degeneration | Multiple System Atrophy
Item
1. other idiopathic parkinsonian syndromes, e.g., progressive supranuclear palsy, cortico-basal syndrome, or multiple system atrophy
boolean
C0242422 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C0038868 (UMLS CUI [2])
C0393570 (UMLS CUI [3])
C0393571 (UMLS CUI [4])
Parkinsonian Disorders Secondary | Parkinsonism due to drug | Parkinsonian Disorders Traumatic | Parkinson Disease, Postencephalitic | Parkinson Disease, Secondary Vascular
Item
2. secondary parkinsonian syndromes (drug-induced, traumatic, encephalitic or vascular)
boolean
C0242422 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0270729 (UMLS CUI [2])
C0242422 (UMLS CUI [3,1])
C0332663 (UMLS CUI [3,2])
C0030568 (UMLS CUI [4])
C0751414 (UMLS CUI [5])
Antiparkinson Agents Change
Item
3. change in antiparkinsonian medication one month prior to enrolment
boolean
C0003405 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Glycopyrrolate | Hypersensitivity Glycopyrrolate
Item
4. prior use of glycopyrrolate with or without known hypersensitivity will be considered an exclusion criterion, as it increases the risk of unblinding due to prior knowledge of potential side effects or therapeutic benefit
boolean
C0017970 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0017970 (UMLS CUI [2,2])
Anticholinergic Agents Dose Change | Pharmaceutical Preparations Dose Change | Pharmaceutical Preparations Affecting Saliva production | Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors | Antipsychotic Agents | Clozapine | quetiapine | Hypnotics | Pharmaceutical Preparations Dose Stable
Item
5. change in the dose one month prior to enrolment of other anticholinergic agents or other drugs potentially affecting saliva production, such as tricyclic antidepressants, mao-a inhibitors, neuroleptics (including clozapine and quetiapine more frequently used in pd) or hypnotics. these mediation will remain in a constant dose throughout the trial;
boolean
C0242896 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1821986 (UMLS CUI [3,3])
C0003290 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
C0040615 (UMLS CUI [6])
C0009079 (UMLS CUI [7])
C0123091 (UMLS CUI [8])
C0020591 (UMLS CUI [9])
C0013227 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0205360 (UMLS CUI [10,3])
Potassium Chloride Oral Product
Item
6. concomitant use of solid oral dosage forms of potassium chloride;
boolean
C3214855 (UMLS CUI [1])
Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Absent | Gender Contraceptive methods Absent | Sexual Abstinence | Intrauterine Devices | Vaginal contraceptive diaphragm | Spermatocidal Agents | Condoms | Contraceptives, Oral
Item
7. pregnancy, breastfeeding, and premenopausal females or males not using adequate contraception; medically acceptable birth control methods for this study include: (1) abstinence (no sexual intercourse); (2) intrauterine device (iud); (3) diaphragm with spermicide; (4) condom with spermicide; and (5) oral contraceptives (birth control pills) + condom/diaphragm with spermicide.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0037862 (UMLS CUI [8])
C0677582 (UMLS CUI [9])
C0009905 (UMLS CUI [10])
Constipation, moderate to severe | Therapy Optimal | MDS-UPDRS
Item
8. moderate-to-severe constipation in spite of optimal treatment (mds-updrs, item 1.11>2);
boolean
C3550392 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
C3639714 (UMLS CUI [3])
Condition Excludes Anticholinergic Agents | Inflammatory Bowel Diseases | Symptoms Suggestive of Inflammatory Bowel Diseases | Glaucoma | Myasthenia Gravis | Prostatic Hypertrophy | URINARY OBSTRUCTIVE SYMPTOMS
Item
9. conditions that preclude anticholinergic therapy, e.g., documented history or symptoms suggestive of inflammatory bowel disease, glaucoma, myasthenia gravis, prostatic hypertrophy or obstructive urinary symptoms;
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0242896 (UMLS CUI [1,3])
C0021390 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0021390 (UMLS CUI [3,3])
C0017601 (UMLS CUI [4])
C0026896 (UMLS CUI [5])
C1739363 (UMLS CUI [6])
C0749941 (UMLS CUI [7])
Exacerbation Due to Glycopyrrolate | Congestive heart failure | Symptoms Suggestive of Congestive heart failure | Coronary heart disease | Gastroesophageal reflux disease | Hyperthyroidism
Item
10. conditions that can be exacerbated by anticholinergic effects of glycopyrrolate, e.g., documented history or symptoms suggestive of congestive heart failure, coronary heart disease, gastro-esophageal reflux disease or hyperthyroidism;
boolean
C4086268 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0017970 (UMLS CUI [1,3])
C0018802 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0018802 (UMLS CUI [3,3])
C0010068 (UMLS CUI [4])
C0017168 (UMLS CUI [5])
C0020550 (UMLS CUI [6])
Hypertensive disease Uncontrolled | Systolic Pressure | Diastolic blood pressure | Use of Electronic sphygmomanometer
Item
11. uncontrolled arterial hypertension (tas>140 mmhg or tad>90 mmhg, using an electronic sphygmomanometer and standardized procedure16);
boolean
C0020538 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C1524063 (UMLS CUI [4,1])
C0183429 (UMLS CUI [4,2])
Tachyarrhythmia | RR Interval Single Measurement
Item
12. tachyarrhythmia (interval rr <0.6 sec.);
boolean
C0080203 (UMLS CUI [1])
C3897782 (UMLS CUI [2])
Thyroid stimulating hormone measurement
Item
13. tsh<0.4 miu/l;
boolean
C0202230 (UMLS CUI [1])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised
Item
14. liver dysfunction (ast, alt, alp >2xupper normal limit);
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
Renal dysfunction | Creatinine clearance measurement | Glycopyrrolate Renal clearance predominant
Item
15. renal dysfunction (creatinine clearance <50 ml/min), as glycopyrrolate has predominant renal clearance;
boolean
C3279454 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0017970 (UMLS CUI [3,1])
C0232813 (UMLS CUI [3,2])
C1542147 (UMLS CUI [3,3])
Informed Consent Unable | Informed Consent Guardian Unable | Informed Consent Patient Representative Unable | Informed Consent Unwilling | Informed Consent Guardian Unwilling | Informed Consent Patient Representative Unwilling
Item
16. inability or unwillingness of subject or legal guardian/representative to give written informed consent;
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C0030701 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0021430 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0021430 (UMLS CUI [5,1])
C1274041 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
C0021430 (UMLS CUI [6,1])
C0030701 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
Study Subject Participation Status | Clinical Trial
Item
17. participation in another investigational study at the time of recruitment or during the prior month.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial