ID

25949

Descrição

Eligibility Question Ropinirole Case Report Form GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

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  1. 30/09/2017 30/09/2017 -
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gsk

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30 de setembro de 2017

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Eligibility Question Ropinirole Case Report Form GSK RRL100013

Inglês

Eligibility Question Ropinirole Case Report Form GSK RRL100013

1 Formulários  
ELIGIBILITY QUESTION (ELIG)
Descrição

ELIGIBILITY QUESTION (ELIG)

Alias
UMLS CUI-1
C1516637
1. Did the subject meet all the entry criteria?
Descrição

Eligibility Question

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Subjects in North America ≥18 years of age who a. Had successfully completed one of the following parent studies: 101468/205, ROX104805; OR b. Had a diagnosis of primary RLS using the IRSSG Diagnostic Criteria, experienced RLS symptoms during both the evening (before 8 PM) and night- time, and had a total score ≥15 on the IRLS Rating Scale at Baseline. Subjects must have had a history of a minimum of 20 evenings/nights of RLS episodes per month (e.g., any combination of evenings and/or nights for ≥ 20 days). During Screening/Washout, RLS symptoms must have been present for at least 4 of 7 evenings/nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for ≥ 4 days).
Descrição

Inclusion Criteria 1

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0035258
2. Subjects must have given written informed consent prior to any specific study procedures.
Descrição

Inclusion Criteria 2

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Subjects who had any medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that presented a safety concern. These may have included, but were 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.
Descrição

Exclusion Criteria 1

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C0031117
2. Subjects who had clinically significant abnormal laboratory or ECG findings not resolved at time of baseline examinations. Abnormal 12-lead ECG findings included, but were not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias.
Descrição

Exclusion Criteria 2

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0013798
3. Subjects with a diastolic blood pressure ≥ 110mmHg or ≤ 50mmHg or systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at the Screening or Baseline visit.
Descrição

Exclusion Criteria 3

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005823
4. Subjects with a history of augmentation and/or end-of-dose rebound symptoms. • Augmentation was defined as RLS symptoms that occurred while on treatment and occurred ≥ 2 hours earlier than they did previously, symptoms which were more severe than when not treated, symptoms which started after less time at rest than they did before treatment, or symptoms which involved other parts of the body, such as the arms or trunk. • End-of-dose rebound was defined as a re-emergence of RLS symptoms in the early morning the day after taking the dose of RLS medication.
Descrição

Exclusion Criteria 4

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0034897
5. Subjects who had exhibited intolerance to ropinirole.
Descrição

Exclusion Criteria 5

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0244821
6. For subjects entering Study 206, certain medications must have been discontinued prior to entering the study. The following medications are prohibited for the duration of the study period which is up to and including the Follow-up visit: • dopamine agonists (including ropinirole IR), dopamine antagonists (e.g., typical neuroleptics, metoclopromide), levodopa/carbidopa The minimum discontinuation period was generally 5 half-lives or 7 consecutive evening/nights medication-free, prior to baseline, whichever was the longer period. If the subject required longer than 2 weeks following the Follow-up visit of the parent study to complete the washout, GSK must have been consulted for further instructions.
Descrição

Exclusion Criteria 6

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178601
7. Other medications, including those with partial dopaminergic activity (e.g., atypical antipsychotics, certain antidepressants such as bupropion, tricyclic antidepressants and monoamine oxidase inhibitors) may have additive activity with ropinirole and were to be used with caution in subjects taking ropinirole. For subjects on stable doses, these agents may have been permitted; however, it was recommended that the dose of the medication remain stable throughout the duration of the study.
Descrição

Exclusion Criteria 7

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178601
8. Night workers or any others whose sleeping habits were incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
Descrição

Exclusion Criteria 8

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0555008
UMLS CUI [2]
C0547101
9. Women who had a positive pregnancy test.
Descrição

Exclusion Criteria 9

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0240802
10. Women of child-bearing potential who were not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, intrauterine device (IUD), diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant).
Descrição

Exclusion Criteria 10

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
11. Subjects who suffered from a primary sleep disorder other than RLS that may have significantly affected the symptoms of RLS (e.g., narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
Descrição

Exclusion Criteria 11

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0236991
12. Subjects diagnosed with movement disorders (e.g., Parkinson’s disease, dyskinesias, and dystonias).
Descrição

Exclusion Criteria 12

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0026650
UMLS CUI [1,2]
C0030567
UMLS CUI [1,3]
C0013384
UMLS CUI [1,4]
C0013421
13. Signs of secondary RLS (e.g., end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).
Descrição

Exclusion Criteria 13

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1536279
14. Subjects who required treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
Descrição

Exclusion Criteria 14

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0439548
15. Subjects with a history of alcohol or substance abuse within the past year.
Descrição

Exclusion Criteria 15

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
16. Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures.
Descrição

Exclusion Criteria 16

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
17. Participation in any clinical drug or device trial (other than Study 101468/205 or ROX104805) in the one month prior to the Baseline Visit.
Descrição

Exclusion Criteria 17

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
Do not admit the subject into this study if any Inclusion / Exclusion criteria is checked unless an exception has been granted by the GSK Medical Monitor and subject is continuing in the study. Please clarify the exemption(s) below
Descrição

exemption

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348482
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Eligibility Question Ropinirole Case Report Form GSK RRL100013

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
ELIGIBILITY QUESTION (ELIG)
C1516637 (UMLS CUI-1)
1. Did the subject meet all the entry criteria?
Item
1. Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age; Study Subject Participation Status; Restless Legs Syndrome
Item
1. Subjects in North America ≥18 years of age who a. Had successfully completed one of the following parent studies: 101468/205, ROX104805; OR b. Had a diagnosis of primary RLS using the IRSSG Diagnostic Criteria, experienced RLS symptoms during both the evening (before 8 PM) and night- time, and had a total score ≥15 on the IRLS Rating Scale at Baseline. Subjects must have had a history of a minimum of 20 evenings/nights of RLS episodes per month (e.g., any combination of evenings and/or nights for ≥ 20 days). During Screening/Washout, RLS symptoms must have been present for at least 4 of 7 evenings/nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for ≥ 4 days).
boolean
C0001779 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0035258 (UMLS CUI [3])
informed consent
Item
2. 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)
Comorbidity diabetes peripheral neuropathy
Item
1. Subjects who had any medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that presented a safety concern. These may have included, but were 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
C0009488 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0031117 (UMLS CUI [1,3])
Laboratory abnormalities; ECG
Item
2. Subjects who had clinically significant abnormal laboratory or ECG findings not resolved at time of baseline examinations. Abnormal 12-lead ECG findings included, but were not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias.
boolean
C1853129 (UMLS CUI [1])
C0013798 (UMLS CUI [2])
Blood pressure
Item
3. Subjects with a diastolic blood pressure ≥ 110mmHg or ≤ 50mmHg or systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at the Screening or Baseline visit.
boolean
C0005823 (UMLS CUI [1])
Recurrence
Item
4. Subjects with a history of augmentation and/or end-of-dose rebound symptoms. • Augmentation was defined as RLS symptoms that occurred while on treatment and occurred ≥ 2 hours earlier than they did previously, symptoms which were more severe than when not treated, symptoms which started after less time at rest than they did before treatment, or symptoms which involved other parts of the body, such as the arms or trunk. • End-of-dose rebound was defined as a re-emergence of RLS symptoms in the early morning the day after taking the dose of RLS medication.
boolean
C0034897 (UMLS CUI [1])
intolerance ropinirole
Item
5. Subjects who had exhibited intolerance to ropinirole.
boolean
C1744706 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
concomitant medication dopamine agonists
Item
6. For subjects entering Study 206, certain medications must have been discontinued prior to entering the study. The following medications are prohibited for the duration of the study period which is up to and including the Follow-up visit: • dopamine agonists (including ropinirole IR), dopamine antagonists (e.g., typical neuroleptics, metoclopromide), levodopa/carbidopa The minimum discontinuation period was generally 5 half-lives or 7 consecutive evening/nights medication-free, prior to baseline, whichever was the longer period. If the subject required longer than 2 weeks following the Follow-up visit of the parent study to complete the washout, GSK must have been consulted for further instructions.
boolean
C2347852 (UMLS CUI [1,1])
C0178601 (UMLS CUI [1,2])
concomitant medication dopamine agonists
Item
7. Other medications, including those with partial dopaminergic activity (e.g., atypical antipsychotics, certain antidepressants such as bupropion, tricyclic antidepressants and monoamine oxidase inhibitors) may have additive activity with ropinirole and were to be used with caution in subjects taking ropinirole. For subjects on stable doses, these agents may have been permitted; however, it was recommended that the dose of the medication remain stable throughout the duration of the study.
boolean
C2347852 (UMLS CUI [1,1])
C0178601 (UMLS CUI [1,2])
Night workers; sleeping habits
Item
8. Night workers or any others whose sleeping habits were 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])
positive pregnancy test
Item
9. Women who had a positive pregnancy test.
boolean
C0240802 (UMLS CUI [1])
Women of child-bearing potential; contraceptive methods
Item
10. Women of child-bearing potential who were not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, intrauterine device (IUD), diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant).
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
primary sleep disorder
Item
11. Subjects who suffered from a primary sleep disorder other than RLS that may have significantly affected the symptoms of RLS (e.g., narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
boolean
C0236991 (UMLS CUI [1])
movement disorders Parkinsons disease dyskinesias dystonias
Item
12. Subjects diagnosed with movement disorders (e.g., Parkinson’s disease, dyskinesias, and dystonias).
boolean
C0026650 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0013384 (UMLS CUI [1,3])
C0013421 (UMLS CUI [1,4])
Secondary restless legs syndrome
Item
13. Signs of secondary RLS (e.g., end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).
boolean
C1536279 (UMLS CUI [1])
Restless Legs Syndrome symptoms day time
Item
14. Subjects who required treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])
Substance abuse disorder
Item
15. Subjects with a history of alcohol or substance abuse within the past year.
boolean
C0038586 (UMLS CUI [1])
compliance behavior
Item
16. 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])
Study subject participation status
Item
17. Participation in any clinical drug or device trial (other than Study 101468/205 or ROX104805) in the one month prior to the Baseline Visit.
boolean
C2348568 (UMLS CUI [1])
exemption
Item
Do not admit the subject into this study if any Inclusion / Exclusion criteria is checked unless an exception has been granted by the GSK Medical Monitor and subject is continuing in the study. Please clarify the exemption(s) below
text
C1516637 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])
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