ID

24366

Descripción

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

Palabras clave

Versiones (1)
  1. 30/7/17 30/7/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

30 de julio de 2017

DOI

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Licencia

Creative Commons BY-NC-ND 3.0
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Eligbility GSK Ropinirole Restless Legs Syndrome 101468

Inglés

Eligbility GSK Ropinirole Restless Legs Syndrome 101468

1 formularios  
Patient Data
Descripción

Patient Data

Alias
UMLS CUI-1
C2707520
Patient Number
Descripción

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Descripción

Centre Number

Tipo de datos

text

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

Visit Date

Tipo de datos

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Inclusion Criteria
Descripción

Inclusion Criteria

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

Inclusion Criteria

Tipo de datos

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?
Descripción

[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.]

Tipo de datos

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?
Descripción

RLS Rating Scale

Tipo de datos

boolean

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

Age

Tipo de datos

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?
Descripción

Body Mass Index

Tipo de datos

boolean

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

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Exclusion Criteria

Tipo de datos

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)?
Descripción

Restless Legs Syndrome during daytime

Tipo de datos

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)?
Descripción

Primary Sleep Disorder

Tipo de datos

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)?
Descripción

Secondary RLS

Tipo de datos

boolean

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

Movement Disorders

Tipo de datos

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.)
Descripción

Medication inducing drowsiness

Tipo de datos

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?
Descripción

Hypertensive medication

Tipo de datos

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)?
Descripción

Blood Pressure

Tipo de datos

boolean

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

Orthostatic Hypotension

Tipo de datos

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)
Descripción

Over-the-Counter Medicine

Tipo de datos

boolean

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

Hypersensitivity dopamine agonist

Tipo de datos

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)?
Descripción

Contraceptive Methods

Tipo de datos

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?
Descripción

Gynaecological Status

Tipo de datos

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)
Descripción

Substance Use Disorder

Tipo de datos

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.)
Descripción

Comorbidity

Tipo de datos

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.
Descripción

Physical Examination

Tipo de datos

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)
Descripción

Laboratory Procedures

Tipo de datos

boolean

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

12 Lead ECG

Tipo de datos

boolean

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

Urine drug screening

Tipo de datos

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?
Descripción

Compliance

Tipo de datos

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?
Descripción

Study Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligbility GSK Ropinirole Restless Legs Syndrome 101468

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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