ID

43978

Description

Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

Keywords

Versions (6)
  1. 8/17/17 8/17/17 -
  2. 8/17/17 8/17/17 -
  3. 8/28/17 8/28/17 -
  4. 9/1/17 9/1/17 -
  5. 9/4/17 9/4/17 -
  6. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY-NC 3.0
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visit 1 inclusion/exclusion criteria starting dose of ropinirole Parkinson's Disease 101468/166

English

visit 1 inclusion/exclusion criteria starting dose of ropinirole Parkinson's Disease 101468/166

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Description

patient's initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
INCLUSION CRITERIA
Description

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.
Description

adults without childbearing potential

Data type

integer

Measurement units
  • years
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.
Description

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

Data type

integer

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

candidate and authorization for dopaminergic therapy

Data type

integer

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

informed consent

Data type

integer

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

date informed consent signed:

Data type

date

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

investigator's signature

Data type

text

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

exception approved by medical monitor

Data type

integer

Alias
UMLS CUI [1,1]
C1708968
UMLS CUI [1,2]
C1705847
Exception approved by
Description

name of medical monitor

Data type

text

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

date of approval

Data type

date

Alias
UMLS CUI [1]
C2346844
EXCLUSION CRITERIA
Description

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).
Description

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

Data type

integer

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.
Description

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

Data type

integer

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0700225
UMLS CUI [4]
C0438215
UMLS CUI [5]
C0522055
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.
Description

severe dizziness, syncope or orthostatic hypotension

Data type

integer

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

sleep disorder on Epworth sleep scale

Data type

integer

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.)
Description

L-dopa treatment

Data type

integer

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.)
Description

dopaminergic therapy

Data type

integer

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.
Description

hormone replacement therapy, CYP1A2 inducers or CYP1A2 inhibitors

Data type

integer

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.
Description

hypersensitivity or adverse reactions to ropinirole

Data type

integer

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.
Description

investigational drugs

Data type

integer

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).
Description

drug abuse or abuse of alcohol

Data type

integer

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.
Description

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

Data type

integer

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

blood donation

Data type

integer

Alias
UMLS CUI [1]
C0005794
Pregnancy or lactation
Description

pregnancy or lactation

Data type

text

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

investigator's signature

Data type

text

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

exception approved by medical monitor

Data type

integer

Alias
UMLS CUI [1,1]
C1708968
UMLS CUI [1,2]
C1705847
Exception approved by
Description

name of medical monitor

Data type

text

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

date of approval

Data type

date

Alias
UMLS CUI [1]
C2346844
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Similar models

visit 1 inclusion/exclusion criteria starting dose of ropinirole Parkinson's Disease 101468/166

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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.
integer
C0001675 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
adults without childbearing potential
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Diagnosis of idiopathic Parkinson's disease according to Hoehn & Yahr Stage I-III based on medical history and neurological examination.
integer
C0030567 (UMLS CUI [1,1])
C0451215 (UMLS CUI [1,2])
adults without childbearing potential
Code List
Diagnosis of idiopathic Parkinson's disease according to Hoehn & Yahr Stage I-III based on medical history and neurological examination.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Candidate for dopaminergic therapy and warrants/requires dopaminergic therapy.
integer
C0013036 (UMLS CUI [1,1])
C0680281 (UMLS CUI [1,2])
adults without childbearing potential
Code List
Candidate for dopaminergic therapy and warrants/requires dopaminergic therapy.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Written informed consent prior to admission to the study.
integer
C0021430 (UMLS CUI [1])
adults without childbearing potential
Code List
Written informed consent prior to admission to the study.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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])
Item
If any question is answered YES, was exception approved by Medical Monitor?
integer
C1708968 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
adults without childbearing potential
Code List
If any question is answered YES, was exception approved by Medical Monitor?
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
name of medical monitor
Item
Exception approved by
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)
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).
integer
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])
adults without childbearing potential
Code List
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).
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.
integer
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
C0438215 (UMLS CUI [4])
C0522055 (UMLS CUI [5])
adults without childbearing potential
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.
integer
C0012833 (UMLS CUI [1])
C0039070 (UMLS CUI [2])
C0020651 (UMLS CUI [3])
adults without childbearing potential
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Significant sleep disorder or screening Epworth Sleep Score~ 9.
integer
C0851578 (UMLS CUI [1,1])
C3541276 (UMLS CUI [1,2])
adults without childbearing potential
Code List
Significant sleep disorder or screening Epworth Sleep Score~ 9.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.)
integer
C0023570 (UMLS CUI [1])
adults without childbearing potential
Code List
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.)
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.)
integer
C0013036 (UMLS CUI [1])
adults without childbearing potential
Code List
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.)
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.
integer
C0282402 (UMLS CUI [1])
C3850050 (UMLS CUI [2])
C3850068 (UMLS CUI [3])
adults without childbearing potential
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.
integer
C0020517 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0244821 (UMLS CUI [2,2])
adults without childbearing potential
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Use of any investigational drug within the 30 days or 5 half-lives (whichever is longer) before the start of study dosing.
integer
C0013230 (UMLS CUI [1])
adults without childbearing potential
Code List
Use of any investigational drug within the 30 days or 5 half-lives (whichever is longer) before the start of study dosing.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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).
integer
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
adults without childbearing potential
Code List
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).
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.
integer
C1321605 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
adults without childbearing potential
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Blood donation within the previous two months.
integer
C0005794 (UMLS CUI [1])
adults without childbearing potential
Code List
Blood donation within the previous two months.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Pregnancy or lactation
text
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
pregnancy or lactation
Code List
Pregnancy or lactation
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not done (Not done)
investigator's signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Item
If any question is answered YES, was exception approved by Medical Monitor?
integer
C1708968 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
adults without childbearing potential
Code List
If any question is answered YES, was exception approved by Medical Monitor?
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
name of medical monitor
Item
Exception approved by
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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