Informatie:
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ID
24337
Beschrijving
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
Trefwoorden
Versies (1)
- 30-07-17 30-07-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
30 juli 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Eligibility Question Baseline Ropinirole NCT00632736
Eligibility Question Baseline
- StudyEvent: ODM
Similar models
Eligibility Question Baseline
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
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])
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])
C0006147 (UMLS CUI [2])
study drug
Item
7. Use of an investigational drug throughout the treatment period.
boolean
C0304229 (UMLS CUI [1])