ID

24337

Descrizione

Study part: Eligibility Question Baseline.An Open-Label Extension phase 3 Study with REQUIP (ropinirole) CR for Subjects from Studies 101468/165, 101468/168 and 101468/169. Patient Level Data

Keywords

versioni (1)
  1. 30/07/17 30/07/17 -
Titolare del copyright

GlaxoSmithKline

Caricato su

30 luglio 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Eligibility Question Baseline Ropinirole NCT00632736

Inglese

Eligibility Question Baseline

1 moduli  
ELIGIBILITY QUESTION
Descrizione

ELIGIBILITY QUESTION

Alias
UMLS CUI-1
C1516637
Subject ldentifier
Descrizione

Subject ldentifier

Tipo di dati

text

Alias
UMLS CUI [1]
C2826694
Did the subject meet all the entry criteria?
Descrizione

Eligibility criteria

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1516637
INCLUSION CRITERIA
Descrizione

INCLUSION CRITERIA

Alias
UMLS CUI-1
C1512693
1. Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week downtitration at the end of treatment/ early withdrawal).
Descrizione

Study Subject Participation Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
2. Subjects must not have a break in medication between completing the feeder study (including the downtitration phase for studies 168 and 169) and beginning treatment in study 248.
Descrizione

medication continuation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4287894
3. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant)
Descrizione

Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0700589
4. Provide written informed consent for this study.
Descrizione

informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
5. Be willing and able to comply with study procedures.
Descrizione

study compliance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1321605
EXCLUSION CRITERIA
Descrizione

EXCLUSION CRITERIA

Alias
UMLS CUI-1
C0680251
1. Patients with any ongoing clinically significant adverse events at the end of the "feeder" studies.
Descrizione

adverse events

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0877248
2. Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma).
Descrizione

comorbidity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009488
3. Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the feeder study (REQUIP study 165, 168 or 169).
Descrizione

Laboratory measurement; ECG

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0681902
UMLS CUI [2]
C0013798
4. Subjects with severe dizziness or fainting due to postural hypotension on standing.
Descrizione

dizziness; fainting; postural hypotension

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0012833
UMLS CUI [2]
C0039070
UMLS CUI [3]
C0020651
5. 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 enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
Descrizione

concomitant medication

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2347852
6. Women who are pregnant or breast-feeding.
Descrizione

pregnancy; Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. Use of an investigational drug throughout the treatment period.
Descrizione

study drug

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0304229
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Similar models

Eligibility Question Baseline

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
ELIGIBILITY QUESTION
C1516637 (UMLS CUI-1)
Subject ldentifier
Item
Subject ldentifier
text
C2826694 (UMLS CUI [1])
Eligibility criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
INCLUSION CRITERIA
C1512693 (UMLS CUI-1)
Study Subject Participation Status
Item
1. Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week downtitration at the end of treatment/ early withdrawal).
boolean
C2348568 (UMLS CUI [1])
medication continuation
Item
2. Subjects must not have a break in medication between completing the feeder study (including the downtitration phase for studies 168 and 169) and beginning treatment in study 248.
boolean
C4287894 (UMLS CUI [1])
Contraceptive methods
Item
3. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant)
boolean
C0700589 (UMLS CUI [1])
informed consent
Item
4. Provide written informed consent for this study.
boolean
C0021430 (UMLS CUI [1])
study compliance
Item
5. Be willing and able to comply with study procedures.
boolean
C1321605 (UMLS CUI [1])
Item Group
EXCLUSION CRITERIA
C0680251 (UMLS CUI-1)
adverse events
Item
1. Patients with any ongoing clinically significant adverse events at the end of the "feeder" studies.
boolean
C0877248 (UMLS CUI [1])
comorbidity
Item
2. Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma).
boolean
C0009488 (UMLS CUI [1])
Laboratory measurement; ECG
Item
3. Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the feeder study (REQUIP study 165, 168 or 169).
boolean
C0681902 (UMLS CUI [1])
C0013798 (UMLS CUI [2])
dizziness; fainting; postural hypotension
Item
4. Subjects with severe dizziness or fainting due to postural hypotension on standing.
boolean
C0012833 (UMLS CUI [1])
C0039070 (UMLS CUI [2])
C0020651 (UMLS CUI [3])
concomitant medication
Item
5. 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 enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
boolean
C2347852 (UMLS CUI [1])
pregnancy; Breast Feeding
Item
6. Women who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
study drug
Item
7. Use of an investigational drug throughout the treatment period.
boolean
C0304229 (UMLS CUI [1])
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