ID

25952

Beskrivning

Inclusion/exclusion criteria Ropinirole Case Report Form GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Nyckelord

Versioner (2)
  1. 2017-10-01 2017-10-01 -
  2. 2021-09-20 2021-09-20 -
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1 oktober 2017

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Visit 1 inclusion/exclusion criteria starting dose of ropinirole Ropinirole Case Report Form GSK RRL100013

Engelsk

Visit 1 inclusion/exclusion criteria starting dose of ropinirole Ropinirole Case Report Form GSK RRL100013

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beskrivning

patient's initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beskrivning

patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
INCLUSION CRITERIA
Beskrivning

INCLUSION CRITERIA

Alias
UMLS CUI-1
C1512693
Men or women (who are not of childbearing potential, defined as those who have been naturally free of menses for at least 2 years or have undergone hysterectomy or surgical sterilization), age 30 years or older.
Beskrivning

adults without childbearing potential

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C3831118
Diagnosis of idiopathic Parkinson's disease according to Hoehn & Yahr Stage I-III based on medical history and neurological examination.
Beskrivning

diagnosis of Parkinson's disease according to Hoehn&Yahr Stage I-III

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0451215
Candidate for dopaminergic therapy and warrants/requires dopaminergic therapy.
Beskrivning

candidate and authorization for dopaminergic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013036
UMLS CUI [1,2]
C0680281
Written informed consent prior to admission to the study.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Date informed consent signed
Beskrivning

date informed consent signed:

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
Investigator's Signature
Beskrivning

investigator's signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
If any question is answered YES, was exception approved by Medical Monitor?
Beskrivning

exception approved by medical monitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708968
UMLS CUI [1,2]
C1705847
name of medical monitor
Beskrivning

Exception approved by

Datatyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Date of approval
Beskrivning

date of approval

Datatyp

date

Alias
UMLS CUI [1]
C2346844
EXCLUSION CRITERIA
Beskrivning

EXCLUSION CRITERIA

Alias
UMLS CUI-1
C0680251
Presence - or history within the previous 3 months - of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological, (otherthan Parkinson's disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrythmias, CVA), or active malignancy (other than basal cell cancer).
Beskrivning

psychiatric, hematological, renal, hepatic, endocrinological, neurological or cardiovascular diseases or active malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0018939
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0014130
UMLS CUI [6]
C0027765
UMLS CUI [7]
C0007222
UMLS CUI [8]
C0006826
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine > 2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at screening.
Beskrivning

AST or ALT or serum creatinine increased or other clinically significant laboratory or ECG abnormalities

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0700225
UMLS CUI [4]
C0438215
UMLS CUI [5]
C1832603
Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure (supine, erect) from baseline values of 30 mmHg for systolic pressure; 20 mmHg for diastolic pressure.
Beskrivning

severe dizziness, syncope or orthostatic hypotension

Datatyp

boolean

Alias
UMLS CUI [1]
C0012833
UMLS CUI [2]
C0039070
UMLS CUI [3]
C0020651
Significant sleep disorder or screening Epworth Sleep Score~ 9.
Beskrivning

sleep disorder on Epworth sleep scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0851578
UMLS CUI [1,2]
C3541276
History of previous treatment with any L-dopa dose or preparation for more than weeks. (L-dopa treatment must be discontinued for at least a 2-week wash-out period before enrollment.)
Beskrivning

L-dopa treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0023570
History of other dopaminergic therapy within two weeks before enrollment. (Note: Patients on dopaminergic therapy may be enrolled if the agent is stopped for a 2-week wash-out period prior to enrollment. Patients on selegiline may be enrolled, but must remain on their current dose during study participation.)
Beskrivning

dopaminergic therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0013036
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially induce CYP1A2 (e.g., ciprofloxacin, fluvoxacine, cimetidine, ethinyloestradiol) or inhibit CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to enrollment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through Day 14.
Beskrivning

hormone replacement therapy, CYP1A2 inducers or CYP1A2 inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C3850050
UMLS CUI [3]
C3850068
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure. In particular, patients with inadequate tolerance of ropinirole at doses below 12 mg per day are to be excluded.
Beskrivning

hypersensitivity or adverse reactions to ropinirole

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0244821
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0244821
Use of any investigational drug within the 30 days or 5 half-lives (whichever is longer) before the start of study dosing.
Beskrivning

investigational drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
Recent history, or suspicion, of drug dependence or abuse of alcohol (with alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units; one unit is equivalent to half a pint of beer, one measure of spirits, or one glass of wine).
Beskrivning

drug abuse or abuse of alcohol

Datatyp

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0085762
Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
Beskrivning

concern about the patient's compliance behavior and the use of new or prohibited concomitant medications

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0422727
UMLS CUI [1,3]
C2347852
Blood donation within the previous two months.
Beskrivning

blood donation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005794
Pregnancy or lactation
Beskrivning

pregnancy or lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Investigator's Signature
Beskrivning

investigator's signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
If any question is answered YES, was exception approved by Medical Monitor?
Beskrivning

exception approved by medical monitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708968
UMLS CUI [1,2]
C1705847
name of medical monitor
Beskrivning

Exception approved by

Datatyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Date of approval
Beskrivning

date of approval

Datatyp

date

Alias
UMLS CUI [1]
C2346844
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Similar models

Visit 1 inclusion/exclusion criteria starting dose of ropinirole Ropinirole Case Report Form GSK RRL100013

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
Item Group
INCLUSION CRITERIA
C1512693 (UMLS CUI-1)
adults without childbearing potential
Item
Men or women (who are not of childbearing potential, defined as those who have been naturally free of menses for at least 2 years or have undergone hysterectomy or surgical sterilization), age 30 years or older.
boolean
C0001675 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
diagnosis of Parkinson's disease according to Hoehn&Yahr Stage I-III
Item
Diagnosis of idiopathic Parkinson's disease according to Hoehn & Yahr Stage I-III based on medical history and neurological examination.
boolean
C0030567 (UMLS CUI [1,1])
C0451215 (UMLS CUI [1,2])
candidate and authorization for dopaminergic therapy
Item
Candidate for dopaminergic therapy and warrants/requires dopaminergic therapy.
boolean
C0013036 (UMLS CUI [1,1])
C0680281 (UMLS CUI [1,2])
informed consent
Item
Written informed consent prior to admission to the study.
boolean
C0021430 (UMLS CUI [1])
date informed consent signed:
Item
Date informed consent signed
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
investigator's signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
exception approved by medical monitor
Item
If any question is answered YES, was exception approved by Medical Monitor?
boolean
C1708968 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
name of medical monitor
Item
name of medical monitor
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
date of approval
Item
Date of approval
date
C2346844 (UMLS CUI [1])
Item Group
EXCLUSION CRITERIA
C0680251 (UMLS CUI-1)
psychiatric, hematological, renal, hepatic, endocrinological, neurological or cardiovascular diseases or active malignancy
Item
Presence - or history within the previous 3 months - of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological, (otherthan Parkinson's disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrythmias, CVA), or active malignancy (other than basal cell cancer).
boolean
C0004936 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0006826 (UMLS CUI [8])
AST or ALT or serum creatinine increased or other clinically significant laboratory or ECG abnormalities
Item
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine > 2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at screening.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
C0438215 (UMLS CUI [4])
C1832603 (UMLS CUI [5])
severe dizziness, syncope or orthostatic hypotension
Item
Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure (supine, erect) from baseline values of 30 mmHg for systolic pressure; 20 mmHg for diastolic pressure.
boolean
C0012833 (UMLS CUI [1])
C0039070 (UMLS CUI [2])
C0020651 (UMLS CUI [3])
sleep disorder on Epworth sleep scale
Item
Significant sleep disorder or screening Epworth Sleep Score~ 9.
boolean
C0851578 (UMLS CUI [1,1])
C3541276 (UMLS CUI [1,2])
L-dopa treatment
Item
History of previous treatment with any L-dopa dose or preparation for more than weeks. (L-dopa treatment must be discontinued for at least a 2-week wash-out period before enrollment.)
boolean
C0023570 (UMLS CUI [1])
dopaminergic therapy
Item
History of other dopaminergic therapy within two weeks before enrollment. (Note: Patients on dopaminergic therapy may be enrolled if the agent is stopped for a 2-week wash-out period prior to enrollment. Patients on selegiline may be enrolled, but must remain on their current dose during study participation.)
boolean
C0013036 (UMLS CUI [1])
hormone replacement therapy, CYP1A2 inducers or CYP1A2 inhibitors
Item
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially induce CYP1A2 (e.g., ciprofloxacin, fluvoxacine, cimetidine, ethinyloestradiol) or inhibit CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to enrollment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through Day 14.
boolean
C0282402 (UMLS CUI [1])
C3850050 (UMLS CUI [2])
C3850068 (UMLS CUI [3])
hypersensitivity or adverse reactions to ropinirole
Item
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure. In particular, patients with inadequate tolerance of ropinirole at doses below 12 mg per day are to be excluded.
boolean
C0020517 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0244821 (UMLS CUI [2,2])
investigational drugs
Item
Use of any investigational drug within the 30 days or 5 half-lives (whichever is longer) before the start of study dosing.
boolean
C0013230 (UMLS CUI [1])
drug abuse or abuse of alcohol
Item
Recent history, or suspicion, of drug dependence or abuse of alcohol (with alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units; one unit is equivalent to half a pint of beer, one measure of spirits, or one glass of wine).
boolean
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
concern about the patient's compliance behavior and the use of new or prohibited concomitant medications
Item
Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
boolean
C1321605 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
blood donation
Item
Blood donation within the previous two months.
boolean
C0005794 (UMLS CUI [1])
pregnancy or lactation
Item
Pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
investigator's signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
exception approved by medical monitor
Item
If any question is answered YES, was exception approved by Medical Monitor?
boolean
C1708968 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
name of medical monitor
Item
name of medical monitor
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
date of approval
Item
Date of approval
date
C2346844 (UMLS CUI [1])
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