ID

24366

Beschreibung

Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Eligibility

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  1. 30.07.17 30.07.17 -
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GlaxoSmithKline

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30. Juli 2017

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Eligbility GSK Ropinirole Restless Legs Syndrome 101468

Englisch

Eligbility GSK Ropinirole Restless Legs Syndrome 101468

1 Formulare  
Patient Data
Beschreibung

Patient Data

Alias
UMLS CUI-1
C2707520
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Beschreibung

Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Beschreibung

Visit Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Does the subject meet the following eligibilty criteria? Answer the following questions by marking the appropriate box.
Beschreibung

Inclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
1. Is the patient male or female and diagnosed RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms per month?
Beschreibung

[Please note - at screening only, for a patient already receiving medication for RLS, the Investigator should use their clinical judgement to decide wether that patient would suffer from a minimum of 15 nights with RLS symptoms if they were not taking any medication.]

Datentyp

boolean

Alias
UMLS CUI [1]
C0035258
2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?
Beschreibung

RLS Rating Scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0449820
3. Is the patient aged between 18 and 79 years od, inclusive?
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. Does the patient have a body mass index (BMI= weight kg/ height m^2) within the range 19 to 29 kg/m^2?
Beschreibung

Body Mass Index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
5. Has the patient given written informed consent prior to any specific study procedures being performed?
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Does the subject meet the following eligibility criteria? Answer the following questions by marking the appropriate box.
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
1. Does the patient suffer rom RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?
Beschreibung

Restless Legs Syndrome during daytime

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0332169
2. Does the patient suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleep walking disorder and breathing related sleep disorder)?
Beschreibung

Primary Sleep Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0236991
3. Does the patient have signs of secondary RLS (e.g. renal failure [end-stage renal disease], iron deficient anaemia or pregnancy at baseline)?
Beschreibung

Secondary RLS

Datentyp

boolean

Alias
UMLS CUI [1]
C1536279
4. Does the patient suffer from movement disorders (e.g. Parkinson's disease, dyskinesias, and dystonias)?
Beschreibung

Movement Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0026650
5. Is the patient taking any medication known to induce drowsiness, affect RLS or sleep? (The minimum discontinuation period is 5 half lives or 3 consecutive nights medication free, prior to baseline, whichever is the longer period.)
Beschreibung

Medication inducing drowsiness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013144
6. Is the patient taking any medications known to affect blood pressure of autonomic control of blood pressure, e.g. anti-hypertensive medication, beta-blockers?
Beschreibung

Hypertensive medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0684167
7. Does the patient have diastolic blood pressure ≥ 110 mmHg or ≤ 50 mmHg OR systolic blood pressure ≥ 180 mmHg or ≤ 90 mmHg at baseline (Day 1 pre-dose)?
Beschreibung

Blood Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0005823
8. Does the patient have a history or presence of symptomatic orthostatic hypotension?
Beschreibung

Orthostatic Hypotension

Datentyp

boolean

Alias
UMLS CUI [1]
C0020651
9. Has the patient received over-the-counter ((OTC) medicine within 48 hours before the first dose of study drug? (Patients who have taken OTC medication may still be entered with the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety)
Beschreibung

Over-the-Counter Medicine

Datentyp

boolean

Alias
UMLS CUI [1]
C0013231
10. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?
Beschreibung

Hypersensitivity dopamine agonist

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0178601
11. Is the patient a woman of child-bearing potential who is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, I.U.D., diaphragm in conjugation with spermicidal foam and condom on the male partner, or system contraception (i.e., Norplant)?
Beschreibung

Contraceptive Methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
12. Is the patient a female of child bearing potential who has a positive pregnancy test or who is lactating at screening or day 1 visit?
Beschreibung

Gynaecological Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. Does the patient meets DSM-IV criteria for 'abuse' (alcohol or drugs) or substance 'dependence' within 6 months prior to screening? (abuse of alcohol defined as a daily intake of greater than 3 units for males, or 2 units for females (one unit is equivalent to 1 beer, 1.5 ounces of hard liquor or one small glass of wine)
Beschreibung

Substance Use Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
14. Does the patient have clinicallsy significant or unstable medical conditions which in the opinion of the Investigator would render the patient unsuitable for the study (e.g. severe cardiovascular disease, hepatic or renal failure, etc.)
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
15. Does the patients have an abnormality on physical examination? A patient with a clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with a study procedure.
Beschreibung

Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0031809
16. Does the patients have an abnormality on clinical chemistry of haematology examination at screening? (Patients with laboratory parameters outside the reference range for this age group will only be included if the investigator considers that such findings will not introduce additional risk factors)
Beschreibung

Laboratory Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0022885
17. Does the patient have an abnormal 12 lead ECG at the screening visit?
Beschreibung

12 Lead ECG

Datentyp

boolean

Alias
UMLS CUI [1]
C1623258
18. Does the patient have a positive urine test for drug of abuse at screening?
Beschreibung

Urine drug screening

Datentyp

boolean

Alias
UMLS CUI [1]
C0202274
19. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or otther study procedures?
Beschreibung

Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
20. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?
Beschreibung

Study Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligbility GSK Ropinirole Restless Legs Syndrome 101468

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient Data
C2707520 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Inclusion Criteria
Item
Does the subject meet the following eligibilty criteria? Answer the following questions by marking the appropriate box.
boolean
C1512693 (UMLS CUI [1])
Restless Legs Syndrome
Item
1. Is the patient male or female and diagnosed RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms per month?
boolean
C0035258 (UMLS CUI [1])
RLS Rating Scale
Item
2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?
boolean
C0035258 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Age
Item
3. Is the patient aged between 18 and 79 years od, inclusive?
boolean
C0001779 (UMLS CUI [1])
Body Mass Index
Item
4. Does the patient have a body mass index (BMI= weight kg/ height m^2) within the range 19 to 29 kg/m^2?
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
5. Has the patient given written informed consent prior to any specific study procedures being performed?
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Exclusion Criteria
Item
Does the subject meet the following eligibility criteria? Answer the following questions by marking the appropriate box.
boolean
C0680251 (UMLS CUI [1])
Restless Legs Syndrome during daytime
Item
1. Does the patient suffer rom RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?
boolean
C0035258 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
Primary Sleep Disorder
Item
2. Does the patient suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleep walking disorder and breathing related sleep disorder)?
boolean
C0236991 (UMLS CUI [1])
Secondary RLS
Item
3. Does the patient have signs of secondary RLS (e.g. renal failure [end-stage renal disease], iron deficient anaemia or pregnancy at baseline)?
boolean
C1536279 (UMLS CUI [1])
Movement Disorders
Item
4. Does the patient suffer from movement disorders (e.g. Parkinson's disease, dyskinesias, and dystonias)?
boolean
C0026650 (UMLS CUI [1])
Medication inducing drowsiness
Item
5. Is the patient taking any medication known to induce drowsiness, affect RLS or sleep? (The minimum discontinuation period is 5 half lives or 3 consecutive nights medication free, prior to baseline, whichever is the longer period.)
boolean
C0013227 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Hypertensive medication
Item
6. Is the patient taking any medications known to affect blood pressure of autonomic control of blood pressure, e.g. anti-hypertensive medication, beta-blockers?
boolean
C0684167 (UMLS CUI [1])
Blood Pressure
Item
7. Does the patient have diastolic blood pressure ≥ 110 mmHg or ≤ 50 mmHg OR systolic blood pressure ≥ 180 mmHg or ≤ 90 mmHg at baseline (Day 1 pre-dose)?
boolean
C0005823 (UMLS CUI [1])
Orthostatic Hypotension
Item
8. Does the patient have a history or presence of symptomatic orthostatic hypotension?
boolean
C0020651 (UMLS CUI [1])
Over-the-Counter Medicine
Item
9. Has the patient received over-the-counter ((OTC) medicine within 48 hours before the first dose of study drug? (Patients who have taken OTC medication may still be entered with the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety)
boolean
C0013231 (UMLS CUI [1])
Hypersensitivity dopamine agonist
Item
10. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?
boolean
C0020517 (UMLS CUI [1,1])
C0178601 (UMLS CUI [1,2])
Contraceptive Methods
Item
11. Is the patient a woman of child-bearing potential who is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, I.U.D., diaphragm in conjugation with spermicidal foam and condom on the male partner, or system contraception (i.e., Norplant)?
boolean
C0700589 (UMLS CUI [1])
Gynaecological Status
Item
12. Is the patient a female of child bearing potential who has a positive pregnancy test or who is lactating at screening or day 1 visit?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorder
Item
13. Does the patient meets DSM-IV criteria for 'abuse' (alcohol or drugs) or substance 'dependence' within 6 months prior to screening? (abuse of alcohol defined as a daily intake of greater than 3 units for males, or 2 units for females (one unit is equivalent to 1 beer, 1.5 ounces of hard liquor or one small glass of wine)
boolean
C0038586 (UMLS CUI [1])
Comorbidity
Item
14. Does the patient have clinicallsy significant or unstable medical conditions which in the opinion of the Investigator would render the patient unsuitable for the study (e.g. severe cardiovascular disease, hepatic or renal failure, etc.)
boolean
C0009488 (UMLS CUI [1])
Physical Examination
Item
15. Does the patients have an abnormality on physical examination? A patient with a clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with a study procedure.
boolean
C0031809 (UMLS CUI [1])
Laboratory Procedures
Item
16. Does the patients have an abnormality on clinical chemistry of haematology examination at screening? (Patients with laboratory parameters outside the reference range for this age group will only be included if the investigator considers that such findings will not introduce additional risk factors)
boolean
C0022885 (UMLS CUI [1])
12 Lead ECG
Item
17. Does the patient have an abnormal 12 lead ECG at the screening visit?
boolean
C1623258 (UMLS CUI [1])
Urine drug screening
Item
18. Does the patient have a positive urine test for drug of abuse at screening?
boolean
C0202274 (UMLS CUI [1])
Compliance
Item
19. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or otther study procedures?
boolean
C1321605 (UMLS CUI [1])
Study Participation Status
Item
20. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?
boolean
C2348568 (UMLS CUI [1])
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