ID

25639

Beschreibung

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Inclusion/exclusion.

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Versionen (2)
  1. 11.08.17 11.08.17 -
  2. 07.09.17 07.09.17 -
Hochgeladen am

7. September 2017

DOI

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Inclusion/exclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

Englisch

Inclusion/exclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulare  
General information
Beschreibung

General information

Protocol identifier
Beschreibung

Protocol identifier

Datentyp

float

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Description
Beschreibung

Visit Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Inclusion and exclusion criteria
Beschreibung

Inclusion and exclusion criteria

Monitor data validation check
Beschreibung

Confirm that the subject is eligible to participate in the study and if not, that all the failed criteria have been marked.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C0030695
Eligibility question
Beschreibung

Eligibility question

Did the subject meet all the entry criteria?
Beschreibung

If No, check all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Beschreibung

Inclusion criteria

1. Men or non-pregnant/non-breast-feeding women of at least 30 years of age but no older than 70 at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplantt System]), during the study and for at least one month prior to randomization and one month following completion of the study.
Beschreibung

age and pregnancy

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1512693
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C1512693
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1512693
2. Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn & Yahr criteria Stages 1-111) and demonstrating lack of control with L-dopa therapy (e.g. mild wearing off, simple on/off fluctuations).
Beschreibung

Diagnosis of idiopathic Parkinson's Disease

Datentyp

text

Alias
UMLS CUI [1]
C0865475
3. Subjects on 600 mg or less of L-dopa therapy for two years or less. Patients on combination therapy such as COMTAN/L-dopa or L-dopa and amantadine are also eligible.
Beschreibung

L-dopa therapy

Datentyp

text

Alias
UMLS CUI [1]
C3806728
4. Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
Beschreibung

stable dose of L-dopa

Datentyp

text

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
5. Provide written informed consent for this study.
Beschreibung

informed consent

Datentyp

text

Alias
UMLS CUI [1]
C0021430
6. Be willing and able to comply with study procedures, including follow-up clinic visits.
Beschreibung

Compliance

Datentyp

text

Exclusion criteria
Beschreibung

Exclusion criteria

1. Any stage of Parkinson's disease in which the subject demonstrates or has a history consistent with dyskinesia.
Beschreibung

Dyskinesia

Datentyp

boolean

Alias
UMLS CUI [1]
C0013384
2. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson's Disease), or cardiovascular disease or active malignancy (other than basal cell cancer).
Beschreibung

Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
3. Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG.
Beschreibung

Abnormality

Datentyp

boolean

Alias
UMLS CUI [1]
C1704258
4. Recent history of severe dizziness or fainting due to postural hypotension on standing.
Beschreibung

dizziness or fainting

Datentyp

boolean

Alias
UMLS CUI [1]
C0012833
UMLS CUI [2]
C0039070
5. Clinically relevant Dementia or a MMSE score of <26.
Beschreibung

Dementia

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
6. Recent history or current evidence of alcohol or drug abuse at the time of enrollment.
Beschreibung

alcohol or drug abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
7. Use of monoamine oxidase (MAO) inhibitors within three weeks of the screening visit except for the selective MAO-B inhibitor, selegiline.
Beschreibung

Use of MAO inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0026457
8. Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure} that would preclude longterm dosing with ropinirole CR.
Beschreibung

adverse reactions to ropinirole

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C0041755
9. Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol} or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment. Subjects already on chronic therapy with any of these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through the end of the Treatment Period.
Beschreibung

hormone replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0282402
10. Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).
Beschreibung

Use of an investigational drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0040223
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Ähnliche Modelle

Inclusion/exclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General information
Protocol identifier
Item
Protocol identifier
float
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Description
Item
Visit Description
text
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Inclusion and exclusion criteria
Monitor data validation check
Item
Monitor data validation check
integer
C1519941 (UMLS CUI [1,1])
C0030695 (UMLS CUI [1,2])
Item Group
Eligibility question
Eligibility question
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion criteria
Item
1. Men or non-pregnant/non-breast-feeding women of at least 30 years of age but no older than 70 at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplantt System]), during the study and for at least one month prior to randomization and one month following completion of the study.
text
C0032961 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
undefined item
Code List
1. Men or non-pregnant/non-breast-feeding women of at least 30 years of age but no older than 70 at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplantt System]), during the study and for at least one month prior to randomization and one month following completion of the study.
CL Item
failed (failed)
C1512693 (UMLS CUI-1)
C1550543 (UMLS CUI-2)
(Comment:en)
CL Item
fulfilled (fulfilled)
C1512693 (UMLS CUI-1)
C1550543 (UMLS CUI-2)
(Comment:en)
Item
2. Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn & Yahr criteria Stages 1-111) and demonstrating lack of control with L-dopa therapy (e.g. mild wearing off, simple on/off fluctuations).
text
C0865475 (UMLS CUI [1])
Diagnosis of idiopathic Parkinson's Disease
Code List
2. Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn & Yahr criteria Stages 1-111) and demonstrating lack of control with L-dopa therapy (e.g. mild wearing off, simple on/off fluctuations).
CL Item
failed (failed)
C0231175 (UMLS CUI-1)
(Comment:en)
CL Item
fulfilled (fulfilled)
C1550543 (UMLS CUI-1)
(Comment:en)
Item
3. Subjects on 600 mg or less of L-dopa therapy for two years or less. Patients on combination therapy such as COMTAN/L-dopa or L-dopa and amantadine are also eligible.
text
C3806728 (UMLS CUI [1])
L-dopa therapy
Code List
3. Subjects on 600 mg or less of L-dopa therapy for two years or less. Patients on combination therapy such as COMTAN/L-dopa or L-dopa and amantadine are also eligible.
CL Item
failed (failed)
CL Item
fulfilled (fulfilled)
Item
4. Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
text
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
stable dose of L-dopaprior to screening
Code List
4. Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
CL Item
failed (failed)
CL Item
fulfilled (fulfilled)
Item
5. Provide written informed consent for this study.
text
C0021430 (UMLS CUI [1])
informed consent
Code List
5. Provide written informed consent for this study.
CL Item
failed (failed)
CL Item
fulfilled (fulfilled)
Item
6. Be willing and able to comply with study procedures, including follow-up clinic visits.
text
Compliance
Code List
6. Be willing and able to comply with study procedures, including follow-up clinic visits.
CL Item
failed (failed)
CL Item
fulfilled (fulfilled)
Item Group
Exclusion criteria
Dyskinesia
Item
1. Any stage of Parkinson's disease in which the subject demonstrates or has a history consistent with dyskinesia.
boolean
C0013384 (UMLS CUI [1])
Disease
Item
2. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson's Disease), or cardiovascular disease or active malignancy (other than basal cell cancer).
boolean
C0012634 (UMLS CUI [1])
Abnormality
Item
3. Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG.
boolean
C1704258 (UMLS CUI [1])
dizziness or fainting
Item
4. Recent history of severe dizziness or fainting due to postural hypotension on standing.
boolean
C0012833 (UMLS CUI [1])
C0039070 (UMLS CUI [2])
Dementia
Item
5. Clinically relevant Dementia or a MMSE score of <26.
boolean
C0497327 (UMLS CUI [1])
alcohol or drug abuse
Item
6. Recent history or current evidence of alcohol or drug abuse at the time of enrollment.
boolean
C0038586 (UMLS CUI [1])
Use of MAO inhibitors
Item
7. Use of monoamine oxidase (MAO) inhibitors within three weeks of the screening visit except for the selective MAO-B inhibitor, selegiline.
boolean
C0026457 (UMLS CUI [1])
adverse reactions to ropinirole
Item
8. Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure} that would preclude longterm dosing with ropinirole CR.
boolean
C0244821 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
hormone replacement therapy
Item
9. Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol} or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment. Subjects already on chronic therapy with any of these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through the end of the Treatment Period.
boolean
C0282402 (UMLS CUI [1])
Use of an investigational drug
Item
10. Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).
boolean
C0013230 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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