ID

44164

Descripción

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Palabras clave

Versiones (2)
  1. 7/2/19 7/2/19 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

Inglés

Screening - Eligibility Question

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Subjects diagnosed with RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria at the Screening Visit.
Descripción

1. Subjects diagnosed with RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria at the Screening Visit.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035258
UMLS CUI [2,1]
C1537061
UMLS CUI [2,2]
C0035258
2. Subjects > 18 years and < 80 years of age.
Descripción

2. Subjects > 18 years and < 80 years of age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. Subjects have had RLS symptoms with a history of a minimum of 20 evening and nights of RLS episodes during the month prior to the Screening Visit (e.g., any combination of evenings and/or nights for >20 days). In the case of a subject currently receiving medication for the treatment of RLS at the Screening Visit, this inclusion criterion can be waived. However, the subject must discontinue and washout any previous medication for the treatment of RLS or sleep prior to the Baseline Visit (Day 0). The minimum discontinuation period for washout is generally 5 half-lives of the medication or 7 consecutive nights medication-free prior to baseline, whichever is the longer period.
Descripción

3. Restless Legs Syndrome; Frequencies (time pattern) | Restless Legs Syndrome; Pharmaceutical Preparations; Washout Period

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439603
UMLS CUI [2,1]
C0035258
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1710661
4. Subjects must be experiencing RLS symptoms requiring treatment prior to bedtime, but no earlier than 5:00 PM.
Descripción

4. Subjects must be experiencing RLS symptoms requiring treatment prior to bedtime, but no earlier than 5:00 PM.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0521112
UMLS CUI [1,4]
C0332152
5. Subjects must have given written informed consent prior to any specific study procedures.
Descripción

5. Subjects must have given written informed consent prior to any specific study procedures.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion criteria
Descripción

Exclusion criteria

Alias
UMLS CUI-1
C0680251
1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
Descripción

1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0332169
2. Signs of secondary RLS (e.g. end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).
Descripción

2. Signs of secondary RLS (e.g. end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1261469
UMLS CUI [2]
C0022661
UMLS CUI [3]
C0162316
UMLS CUI [4]
C0032961
3. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit.
Descripción

3. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0696113
4. Subjects having a clinically significant abnormal lab, ECG, or physical exam findings not resolved by time of baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias
Descripción

Laboratory test result abnormal; Clinical Significance | Electrocardiogram abnormal; Clinical Significance | Physical Examination; Abnormal; Clinical Significance | Myocardial Ischemia | Abnormal cardiac conduction; Clinical Significance | Cardiac Arrhythmia; Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0205161
UMLS CUI [3,3]
C2826293
UMLS CUI [4]
C0151744
UMLS CUI [5,1]
C0232219
UMLS CUI [5,2]
C2826293
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C2826293
5. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
Descripción

5. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0236991
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0035258
UMLS CUI [2,2]
C1457887
UMLS CUI [3]
C0027404
UMLS CUI [4,1]
C0851578
UMLS CUI [4,2]
C0037320
UMLS CUI [5]
C0037672
UMLS CUI [6]
C0236845
6. Subjects diagnosed with movement disorders (e.g. Parkinson’s Disease, dyskinesias, and dystonias).
Descripción

6. Subjects diagnosed with movement disorders (e.g. Parkinson’s Disease, dyskinesias, and dystonias).

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026650
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0013384
UMLS CUI [4]
C0013421
7. Subjects who have medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis).
Descripción

7. Subjects who have medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1280519
UMLS CUI [1,3]
C0220825
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0036043
UMLS CUI [2,4]
C2699424
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0031117
UMLS CUI [5]
C0003873
UMLS CUI [6]
C0016053
UMLS CUI [7]
C0740482
UMLS CUI [8,1]
C0007222
UMLS CUI [8,2]
C0205082
UMLS CUI [9]
C0035078
UMLS CUI [10]
C0085605
UMLS CUI [11]
C0034069
8. Subjects with a history of alcohol or substance abuse within the past year.
Descripción

8. Subjects with a history of alcohol or substance abuse within the past year.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C1299544
9. Subjects with a diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure > 180mmHg or <90mmHg at the Screening or Baseline Visit.
Descripción

9. Subjects with a diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure > 180mmHg or <90mmHg at the Screening or Baseline Visit.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C0871470
10. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and that have not been discontinued prior to the Baseline Visit. These medications include the following: • antidepressants (tricyclic antidepressants, noradrenaline [norepinephrine]/ serotonin re-uptake inhibitors, selective serotonin re-uptake inhibitors, bupropion), anticonvulsants, opioids (including propoxyphene and oxycodone), anxiolytics, all sedatives/hypnotics (including benzodiazepines), lithium, oral neuroleptics, stimulants (including methylphenidate), antipsychotics, dopamine agonists, dopamine antagonists, clonidine, and sedating antihistamines (e.g. chlorpheniramine, diphenhydramine, hydroxyzine) or any preparations containing these
Descripción

10. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and that have not been discontinued prior to the Baseline Visit.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013144
UMLS CUI [1,3]
C0035258
UMLS CUI [1,4]
C0392760
UMLS CUI [1,5]
C0013227
UMLS CUI [1,6]
C0013144
UMLS CUI [1,7]
C0035258
UMLS CUI [1,8]
C0037313
UMLS CUI [1,9]
C0457454
UMLS CUI [2]
C0003290
UMLS CUI [3]
C0162758
UMLS CUI [4]
C0003286
UMLS CUI [5,1]
C0242402
UMLS CUI [5,2]
C0033493
UMLS CUI [5,3]
C0030049
UMLS CUI [6]
C0040616
UMLS CUI [7,1]
C0020592
UMLS CUI [7,2]
C0005064
UMLS CUI [8]
C0023870
UMLS CUI [9,1]
C0040615
UMLS CUI [9,2]
C0442027
UMLS CUI [10,1]
C0304402
UMLS CUI [10,2]
C0025810
UMLS CUI [11]
C0040615
UMLS CUI [12]
C0178601
UMLS CUI [13]
C0242702
UMLS CUI [14]
C0009014
UMLS CUI [15,1]
C1955826
UMLS CUI [15,2]
C0008281
UMLS CUI [15,3]
C0012522
UMLS CUI [15,4]
C0020404
11. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to Baseline Visit. Subjects already on these agents may be enrolled, but must remain on stable doses of the agents from 7 days prior to Baseline Visit through to the follow-up visit at end of study.
Descripción

11. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to Baseline Visit.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C2349954
UMLS CUI [2,1]
C0282402
UMLS CUI [2,2]
C0579004
UMLS CUI [3,1]
C0282402
UMLS CUI [3,2]
C1707811
UMLS CUI [4,1]
C1827504
UMLS CUI [4,2]
C0008809
UMLS CUI [4,3]
C0008783
UMLS CUI [4,4]
C0085228
UMLS CUI [4,5]
C0282402
UMLS CUI [5,1]
C1827490
UMLS CUI [5,2]
C0543414
UMLS CUI [5,3]
C0028978
12. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
Descripción

12. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0555008
UMLS CUI [2,1]
C0547101
UMLS CUI [2,2]
C4698019
UMLS CUI [2,3]
C0035171
UMLS CUI [3,1]
C0547101
UMLS CUI [3,2]
C4698019
UMLS CUI [3,3]
C0680104
13. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.
Descripción

13. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0244821
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0178601
14. Participation in any clinical drug or device trial in the one month prior to the Baseline Visit.
Descripción

14. Participation in any clinical drug or device trial in the one month prior to the Baseline Visit.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
15. Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures.
Descripción

15. Subjects non-compliant with the visit schedule or other study procedures.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
16. Women who have a positive pregnancy test or who are lactating.
Descripción

16. Women who have a positive pregnancy test or who are lactating.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C2828358
17. Women of child-bearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant).
Descripción

17. Women of child-bearing potential who are not practicing a clinically accepted method of contraception.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1960468
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C3176353
UMLS CUI [3]
C0029151
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0021900
UMLS CUI [6,1]
C0042241
UMLS CUI [6,2]
C3843423
UMLS CUI [6,3]
C0009653
UMLS CUI [7,1]
C0700589
UMLS CUI [7,2]
C1515119
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Similar models

Screening - Eligibility Question

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
1. Subjects diagnosed with RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria at the Screening Visit.
Item
1. Subjects diagnosed with RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria at the Screening Visit.
boolean
C0035258 (UMLS CUI [1])
C1537061 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
2. Subjects > 18 years and < 80 years of age
Item
2. Subjects > 18 years and < 80 years of age.
boolean
C0001779 (UMLS CUI [1])
3. Restless Legs Syndrome; Frequencies (time pattern) | Restless Legs Syndrome; Pharmaceutical Preparations; Washout Period
Item
3. Subjects have had RLS symptoms with a history of a minimum of 20 evening and nights of RLS episodes during the month prior to the Screening Visit (e.g., any combination of evenings and/or nights for >20 days). In the case of a subject currently receiving medication for the treatment of RLS at the Screening Visit, this inclusion criterion can be waived. However, the subject must discontinue and washout any previous medication for the treatment of RLS or sleep prior to the Baseline Visit (Day 0). The minimum discontinuation period for washout is generally 5 half-lives of the medication or 7 consecutive nights medication-free prior to baseline, whichever is the longer period.
boolean
C0035258 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1710661 (UMLS CUI [2,3])
4. Subjects must be experiencing RLS symptoms requiring treatment prior to bedtime, but no earlier than 5:00 PM.
Item
4. Subjects must be experiencing RLS symptoms requiring treatment prior to bedtime, but no earlier than 5:00 PM.
boolean
C0035258 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0521112 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
5. Subjects must have given written informed consent prior to any specific study procedures.
Item
5. Subjects must have given written informed consent prior to any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
Item
1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
boolean
C0035258 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0332169 (UMLS CUI [1,4])
2. Signs of secondary RLS (e.g. end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).
Item
2. Signs of secondary RLS (e.g. end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).
boolean
C1261469 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C0162316 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
3. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit.
Item
3. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit.
boolean
C0696113 (UMLS CUI [1])
Laboratory test result abnormal; Clinical Significance | Electrocardiogram abnormal; Clinical Significance | Physical Examination; Abnormal; Clinical Significance | Myocardial Ischemia | Abnormal cardiac conduction; Clinical Significance | Cardiac Arrhythmia; Clinical Significance
Item
4. Subjects having a clinically significant abnormal lab, ECG, or physical exam findings not resolved by time of baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias
boolean
C0438215 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C2826293 (UMLS CUI [3,3])
C0151744 (UMLS CUI [4])
C0232219 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0003811 (UMLS CUI [6,1])
C2826293 (UMLS CUI [6,2])
5. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
Item
5. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
boolean
C0236991 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0027404 (UMLS CUI [3])
C0851578 (UMLS CUI [4,1])
C0037320 (UMLS CUI [4,2])
C0037672 (UMLS CUI [5])
C0236845 (UMLS CUI [6])
6. Subjects diagnosed with movement disorders (e.g. Parkinson’s Disease, dyskinesias, and dystonias).
Item
6. Subjects diagnosed with movement disorders (e.g. Parkinson’s Disease, dyskinesias, and dystonias).
boolean
C0026650 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0013384 (UMLS CUI [3])
C0013421 (UMLS CUI [4])
7. Subjects who have medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern.
Item
7. Subjects who have medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis).
boolean
C0012634 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0036043 (UMLS CUI [2,3])
C2699424 (UMLS CUI [2,4])
C0011849 (UMLS CUI [3])
C0031117 (UMLS CUI [4])
C0003873 (UMLS CUI [5])
C0016053 (UMLS CUI [6])
C0740482 (UMLS CUI [7])
C0007222 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0035078 (UMLS CUI [9])
C0085605 (UMLS CUI [10])
C0034069 (UMLS CUI [11])
8. Subjects with a history of alcohol or substance abuse within the past year.
Item
8. Subjects with a history of alcohol or substance abuse within the past year.
boolean
C0085762 (UMLS CUI [1,1])
C1299544 (UMLS CUI [1,2])
9. Subjects with a diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure > 180mmHg or <90mmHg at the Screening or Baseline Visit.
Item
9. Subjects with a diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure > 180mmHg or <90mmHg at the Screening or Baseline Visit.
boolean
C0428883 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
10. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and that have not been discontinued prior to the Baseline Visit.
Item
10. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and that have not been discontinued prior to the Baseline Visit. These medications include the following: • antidepressants (tricyclic antidepressants, noradrenaline [norepinephrine]/ serotonin re-uptake inhibitors, selective serotonin re-uptake inhibitors, bupropion), anticonvulsants, opioids (including propoxyphene and oxycodone), anxiolytics, all sedatives/hypnotics (including benzodiazepines), lithium, oral neuroleptics, stimulants (including methylphenidate), antipsychotics, dopamine agonists, dopamine antagonists, clonidine, and sedating antihistamines (e.g. chlorpheniramine, diphenhydramine, hydroxyzine) or any preparations containing these
boolean
C0013227 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,5])
C0013144 (UMLS CUI [1,6])
C0035258 (UMLS CUI [1,7])
C0037313 (UMLS CUI [1,8])
C0457454 (UMLS CUI [1,9])
C0003290 (UMLS CUI [2])
C0162758 (UMLS CUI [3])
C0003286 (UMLS CUI [4])
C0242402 (UMLS CUI [5,1])
C0033493 (UMLS CUI [5,2])
C0030049 (UMLS CUI [5,3])
C0040616 (UMLS CUI [6])
C0020592 (UMLS CUI [7,1])
C0005064 (UMLS CUI [7,2])
C0023870 (UMLS CUI [8])
C0040615 (UMLS CUI [9,1])
C0442027 (UMLS CUI [9,2])
C0304402 (UMLS CUI [10,1])
C0025810 (UMLS CUI [10,2])
C0040615 (UMLS CUI [11])
C0178601 (UMLS CUI [12])
C0242702 (UMLS CUI [13])
C0009014 (UMLS CUI [14])
C1955826 (UMLS CUI [15,1])
C0008281 (UMLS CUI [15,2])
C0012522 (UMLS CUI [15,3])
C0020404 (UMLS CUI [15,4])
11. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to Baseline Visit.
Item
11. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to Baseline Visit. Subjects already on these agents may be enrolled, but must remain on stable doses of the agents from 7 days prior to Baseline Visit through to the follow-up visit at end of study.
boolean
C0282402 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0282402 (UMLS CUI [2,1])
C0579004 (UMLS CUI [2,2])
C0282402 (UMLS CUI [3,1])
C1707811 (UMLS CUI [3,2])
C1827504 (UMLS CUI [4,1])
C0008809 (UMLS CUI [4,2])
C0008783 (UMLS CUI [4,3])
C0085228 (UMLS CUI [4,4])
C0282402 (UMLS CUI [4,5])
C1827490 (UMLS CUI [5,1])
C0543414 (UMLS CUI [5,2])
C0028978 (UMLS CUI [5,3])
12. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
Item
12. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
boolean
C0555008 (UMLS CUI [1])
C0547101 (UMLS CUI [2,1])
C4698019 (UMLS CUI [2,2])
C0035171 (UMLS CUI [2,3])
C0547101 (UMLS CUI [3,1])
C4698019 (UMLS CUI [3,2])
C0680104 (UMLS CUI [3,3])
13. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.
Item
13. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.
boolean
C1744706 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0178601 (UMLS CUI [2,2])
14. Participation in any clinical drug or device trial in the one month prior to the Baseline Visit.
Item
14. Participation in any clinical drug or device trial in the one month prior to the Baseline Visit.
boolean
C2348568 (UMLS CUI [1])
15. Subjects non-compliant with the visit schedule or other study procedures.
Item
15. Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures.
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
16. Women who have a positive pregnancy test or who are lactating.
Item
16. Women who have a positive pregnancy test or who are lactating.
boolean
C0032961 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
17. Women of child-bearing potential who are not practicing a clinically accepted method of contraception.
Item
17. Women of child-bearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant).
boolean
C1960468 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C3176353 (UMLS CUI [2,2])
C0029151 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6,1])
C3843423 (UMLS CUI [6,2])
C0009653 (UMLS CUI [6,3])
C0700589 (UMLS CUI [7,1])
C1515119 (UMLS CUI [7,2])
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