ID

25311

Description

Study part: Exclusion Criteria Screening. A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Phase: phase 1. Study Recruitment Status: Completed Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP, Zygara; Zygara, ZIPEREVE, ZEPREVE, Requip Depot, REQUIP, REPREVE, Modutab, ADARTREL. Study Indication : Restless Legs Syndrome. Study ID: 101468/201. Clinical Study ID: 101468/201

Keywords

Versions (2)
  1. 9/1/17 9/1/17 -
  2. 4/23/19 4/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 1, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Exclusion Criteria Screening Ropinirole Restless Legs Syndrome 101468/201

English

Exclusion Criteria Screening

1 forms  
EXCLUSION CRITERIA
Description

EXCLUSION CRITERIA

Alias
UMLS CUI-1
C0680251
Volunteer panel number
Description

Identification number

Data type

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
1. Subjects who smoke more than 10 cigarettes per day.
Description

number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1]
C3694146
2. History or presence of clinically significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
Description

comorbidity cardiovascular, neurological

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C3887460
UMLS CUI [1,3]
C2707261
3. History of postural hypotension or faints.
Description

postural hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0020651
4. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Description

Comorbidity Interferes with drug metabolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0521102
5. The subject has received prescribed medication within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day (apart from medications that are described below), which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subjects’ safety. Subjects who have taken OTC medication (apart from CYP1A2 medications, see below) may still be entered into the study, if, in the opinion of the Principal/Co-investigator in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety.
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
6. Women on HRT treatments during which the proportions of oestrogen and progesterone are not kept constant throughout their 28-day cycle. e.g. some cyclic HRT treatments.
Description

hormone therapy

Data type

text

Alias
UMLS CUI [1]
C0279025
7. Withdrawal, introduction, or change in dose of any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing. Subjects who are on stable doses (no change within 7 days of 1 st dose) of any CYP1A2 medications are permitted to participate, if, in the opinion of the Principal investigator and in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety.
Description

drug dose

Data type

boolean

Alias
UMLS CUI [1]
C0678766
8. Pregnancy and/or breast-feeding.
Description

Pregnancy; breast-feeding

Data type

text

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. Females of child-bearing potential who are not practicing a clinically accepted method of contraception such as surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant ® ).
Description

Females of child-bearing potential; method of contraception

Data type

text

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
10. Female subjects with positive urine/serum pregnancy test result at screening or prior to first dose.
Description

pregnancy test positive

Data type

text

Alias
UMLS CUI [1]
C0240802
11. Recent history (within the last 6 months), or suspicion, of drug dependence or a positive screening or pre-dose drugs of abuse screen.
Description

substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
12. Abuse of alcohol (defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women. One unit is equivalent to half a pint of beer, one measure of spirits or one glass of wine) or a positive screening or pre-dose alcohol test.
Description

alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
13. Positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies.
Description

hepatitis B surface antigen hepatitis C antibody positive; HIV Antibodies

Data type

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0281863
UMLS CUI [2]
C0019683
14. Participation in another clinical trial, blood donation or blood loss less than 90 days before the present study.
Description

study subject participation status; blood donation

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0005794
15. Definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure.
Description

hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0020517
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Similar models

Exclusion Criteria Screening

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
EXCLUSION CRITERIA
C0680251 (UMLS CUI-1)
Identification number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
number of cigarettes per day
Item
1. Subjects who smoke more than 10 cigarettes per day.
boolean
C3694146 (UMLS CUI [1])
comorbidity cardiovascular, neurological
Item
2. History or presence of clinically significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
boolean
C0009488 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C2707261 (UMLS CUI [1,3])
postural hypotension
Item
3. History of postural hypotension or faints.
boolean
C0020651 (UMLS CUI [1])
Comorbidity Interferes with drug metabolism
Item
4. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
medication
Item
5. The subject has received prescribed medication within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day (apart from medications that are described below), which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subjects’ safety. Subjects who have taken OTC medication (apart from CYP1A2 medications, see below) may still be entered into the study, if, in the opinion of the Principal/Co-investigator in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety.
boolean
C0013227 (UMLS CUI [1])
Item
6. Women on HRT treatments during which the proportions of oestrogen and progesterone are not kept constant throughout their 28-day cycle. e.g. some cyclic HRT treatments.
text
C0279025 (UMLS CUI [1])
hormone therapy
Code List
6. Women on HRT treatments during which the proportions of oestrogen and progesterone are not kept constant throughout their 28-day cycle. e.g. some cyclic HRT treatments.
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
drug dose
Item
7. Withdrawal, introduction, or change in dose of any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing. Subjects who are on stable doses (no change within 7 days of 1 st dose) of any CYP1A2 medications are permitted to participate, if, in the opinion of the Principal investigator and in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety.
boolean
C0678766 (UMLS CUI [1])
Item
8. Pregnancy and/or breast-feeding.
text
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hormone therapy
Code List
8. Pregnancy and/or breast-feeding.
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
Item
9. Females of child-bearing potential who are not practicing a clinically accepted method of contraception such as surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant ® ).
text
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
hormone therapy
Code List
9. Females of child-bearing potential who are not practicing a clinically accepted method of contraception such as surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant ® ).
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
Item
10. Female subjects with positive urine/serum pregnancy test result at screening or prior to first dose.
text
C0240802 (UMLS CUI [1])
hormone therapy
Code List
10. Female subjects with positive urine/serum pregnancy test result at screening or prior to first dose.
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
substance use disorder
Item
11. Recent history (within the last 6 months), or suspicion, of drug dependence or a positive screening or pre-dose drugs of abuse screen.
boolean
C0038586 (UMLS CUI [1])
alcohol abuse
Item
12. Abuse of alcohol (defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women. One unit is equivalent to half a pint of beer, one measure of spirits or one glass of wine) or a positive screening or pre-dose alcohol test.
boolean
C0085762 (UMLS CUI [1])
hepatitis B surface antigen hepatitis C antibody positive; HIV Antibodies
Item
13. Positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies.
boolean
C0019168 (UMLS CUI [1,1])
C0281863 (UMLS CUI [1,2])
C0019683 (UMLS CUI [2])
study subject participation status; blood donation
Item
14. Participation in another clinical trial, blood donation or blood loss less than 90 days before the present study.
boolean
C2348568 (UMLS CUI [1])
C0005794 (UMLS CUI [2])
hypersensitivity
Item
15. Definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure.
boolean
C0020517 (UMLS CUI [1])
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