ID

29074

Beschrijving

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

Trefwoorden

Versies (1)
  1. 23-02-18 23-02-18 -
Houder van rechten

GlaxoSmithKline (GSK)

Geüploaded op

23 februari 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

Engels

Eligibility Check 2

1 Formulieren  
  1. StudyEvent: ODM
    1. Eligibility Check 2
Please complete the following inclusion criteria.
Beschrijving

Please complete the following inclusion criteria.

Alias
UMLS CUI-1
C1512693
All patients must have documented RLS symptoms for at least 4 of the 7 nights during the Screening/Washout phase. Documentation will include usual time of symptom onset, location of symptoms, severity of symptoms, and duration of symptoms.
Beschrijving

RLS symptoms

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0035258
Patients with a total score >15 on the IRLS Rating Scale at baseline.
Beschrijving

IRLS Rating Scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Please complete the following exclusion criteria.
Beschrijving

Please complete the following exclusion criteria.

Signs of secondary RLS (i.e. renal failure [end-stage renal disease], iron deficient anemia or pregnancy at baseline).
Beschrijving

Secondary RLS

Datatype

boolean

Alias
UMLS CUI [1]
C1536279
Patients with augmentation on previous treatment and/or end of dose rebound symptoms at baseline. Augmentation is defined as RLS symptoms which occur while on treatment and occur earlier in the afternoon/ evening than they did before, symptoms which are more severe than when not treated, symptoms which start after less time at rest than they did before treatment, or symptoms which involve other parts of the body such as the arms or trunk.
Beschrijving

RLS symptom augmentation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0442805
Patients having a clinically significant abnormal lab, ECG or physical exam findings not resolved by time of baseline examinations.
Beschrijving

Abnormal lab, ECG or physical exam

Datatype

boolean

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C0438154
UMLS CUI [3]
C0031809
Patients taking any medication known to affect RLS or sleep that have not been discontinued prior to the baseline visit. This will include all antidepressants, anticonvulsants, opioids (including propoxyphene and oxycodone), lithium, anxiolytics, hypnotics and sedatives (including benzodiazepines), dopamine agonists, dopamine antagonists, levodopa/carbidopa, neuroleptics, antipsychotics, clonidine, and sedating antihistamines (e.g. chlorpheniramine, diphenhydramine, hydroxyzine) or any preparations containing these antihistamines are prohibited for the duration of the study period (up to and including the follow-up assessment). The minimum discontinuation period is generally 5 half lives or 7 consecutive nights medication free, prior to baseline, whichever is the longer period. Longer minimum discontinuation periods are required for: fluoxetine, monoamine oxidase inhibitors: 4 weeks.
Beschrijving

RLS or sleep affecting medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0392760
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0035258
UMLS CUI [2,3]
C0392760
Patients with a diastolic blood pressure ≥110mmHg or ≤50mmHg OR systolic blood pressure ≥180mmHg or ≤90mmHg at screening or baseline.
Beschrijving

Blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0005823
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. Patients already on stable dosages of these agents may be enrolled but must remain on stable dosages of the agents from 7 days prior to baseline visit through to the follow-up visit at end of study.
Beschrijving

CYP1A2 Inhibitors/Inductors

Datatype

boolean

Alias
UMLS CUI [1,1]
C1827504
UMLS CUI [1,2]
C1827490
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Similar models

Eligibility Check 2

1 Formulieren
  1. StudyEvent: ODM
    1. Eligibility Check 2
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Please complete the following inclusion criteria.
C1512693 (UMLS CUI-1)
RLS symptoms
Item
All patients must have documented RLS symptoms for at least 4 of the 7 nights during the Screening/Washout phase. Documentation will include usual time of symptom onset, location of symptoms, severity of symptoms, and duration of symptoms.
boolean
C1457887 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
IRLS Rating Scale
Item
Patients with a total score >15 on the IRLS Rating Scale at baseline.
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Please complete the following exclusion criteria.
Secondary RLS
Item
Signs of secondary RLS (i.e. renal failure [end-stage renal disease], iron deficient anemia or pregnancy at baseline).
boolean
C1536279 (UMLS CUI [1])
RLS symptom augmentation
Item
Patients with augmentation on previous treatment and/or end of dose rebound symptoms at baseline. Augmentation is defined as RLS symptoms which occur while on treatment and occur earlier in the afternoon/ evening than they did before, symptoms which are more severe than when not treated, symptoms which start after less time at rest than they did before treatment, or symptoms which involve other parts of the body such as the arms or trunk.
boolean
C1457887 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
Abnormal lab, ECG or physical exam
Item
Patients having a clinically significant abnormal lab, ECG or physical exam findings not resolved by time of baseline examinations.
boolean
C0587081 (UMLS CUI [1])
C0438154 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
RLS or sleep affecting medication
Item
Patients taking any medication known to affect RLS or sleep that have not been discontinued prior to the baseline visit. This will include all antidepressants, anticonvulsants, opioids (including propoxyphene and oxycodone), lithium, anxiolytics, hypnotics and sedatives (including benzodiazepines), dopamine agonists, dopamine antagonists, levodopa/carbidopa, neuroleptics, antipsychotics, clonidine, and sedating antihistamines (e.g. chlorpheniramine, diphenhydramine, hydroxyzine) or any preparations containing these antihistamines are prohibited for the duration of the study period (up to and including the follow-up assessment). The minimum discontinuation period is generally 5 half lives or 7 consecutive nights medication free, prior to baseline, whichever is the longer period. Longer minimum discontinuation periods are required for: fluoxetine, monoamine oxidase inhibitors: 4 weeks.
boolean
C0013227 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
Blood pressure
Item
Patients with a diastolic blood pressure ≥110mmHg or ≤50mmHg OR systolic blood pressure ≥180mmHg or ≤90mmHg at screening or baseline.
boolean
C0005823 (UMLS CUI [1])
CYP1A2 Inhibitors/Inductors
Item
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. Patients already on stable dosages of these agents may be enrolled but must remain on stable dosages of the agents from 7 days prior to baseline visit through to the follow-up visit at end of study.
boolean
C1827504 (UMLS CUI [1,1])
C1827490 (UMLS CUI [1,2])
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