ID

29072

Beskrivning

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)

Nyckelord

Versioner (1)
  1. 2018-02-23 2018-02-23 -
Rättsinnehavare

GlaxoSmithKline (GSK)

Uppladdad den

23 februari 2018

DOI

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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

Engelsk

Eligibility Check

1 Formulär  
  1. StudyEvent: ODM
    1. Eligibility Check
Please complete the following inclusion criteria.
Beskrivning

Please complete the following inclusion criteria.

Alias
UMLS CUI-1
C1512693
Patients diagnosed with RLS using International RLS Study Group (IRLSSG) diagnostic criteria
Beskrivning

RLS Diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0035258
Patients have had RLS symptoms with a history of a minimum of 15 nights of RLS symptoms during the previous month. In the case of a patient currently receiving medication for the treatment of RLS at the Screening visit this inclusion criteria can be waived. However, the patient must discontinue any previous medication for the treatment of RLS or sleep prior to the baseline visit (Day 0). The minimum discontinuation period is generally 5 half-lives of the medication or 7 consecutive nights medications free prior to baseline, whichever is the longer period.
Beskrivning

RLS Symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0035258
Patients >18 years and <80 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
The patient must have given written informed consent prior to any specific study procedures.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Please complete the following exclusion criteria.
Beskrivning

Please complete the following exclusion criteria.

Alias
UMLS CUI-1
C0680251
Patients suffering from RLS symptoms during the daytime (daytime defined as 10.00 until 18.00).
Beskrivning

RLS Symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0332169
Patients who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (i.e. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
Beskrivning

Sleep disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0851578
Patients suffering from movement disorders (i.e. Parkinson’s Disease, dyskinesias, and dystonias).
Beskrivning

Movement disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0026650
Patients who have medical conditions which could affect assessments of efficacy (i.e. diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome).
Beskrivning

Comorbidity affecting efficacy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0087111
Patients who have exhibited intolerance to ropinirole or any other dopamine agonist.
Beskrivning

Ropinirole intolerance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0244821
Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to screening.
Beskrivning

Substance abuse/dependence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0038580
Women of child-bearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilisation, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant).
Beskrivning

Contraception

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332197
Women who have a positive pregnancy test or who are lactating.
Beskrivning

Pregnancy or breast feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Patients who have clinically significant or unstable medical conditions which in the opinion of the investigator would render the patient unsuitable for the study (e.g., symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, etc.).
Beskrivning

Unstable medical conditions

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
Patients who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures.
Beskrivning

Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
Patients with a diastolic blood pressure ≥110mmHg or ≤50mmHg OR systolic blood pressure ≥180mmHg or ≤90mmHg at screening or baseline.
Beskrivning

Blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0005823
Participation in any clinical drug or device trial in the three months prior to the baseline visit.
Beskrivning

Participation in other clinical trials

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
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Similar models

Eligibility Check

1 Formulär
  1. StudyEvent: ODM
    1. Eligibility Check
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Please complete the following inclusion criteria.
C1512693 (UMLS CUI-1)
RLS Diagnosis
Item
Patients diagnosed with RLS using International RLS Study Group (IRLSSG) diagnostic criteria
boolean
C0035258 (UMLS CUI [1])
RLS Symptoms
Item
Patients have had RLS symptoms with a history of a minimum of 15 nights of RLS symptoms during the previous month. In the case of a patient currently receiving medication for the treatment of RLS at the Screening visit this inclusion criteria can be waived. However, the patient must discontinue any previous medication for the treatment of RLS or sleep prior to the baseline visit (Day 0). The minimum discontinuation period is generally 5 half-lives of the medication or 7 consecutive nights medications free prior to baseline, whichever is the longer period.
boolean
C1457887 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Age
Item
Patients >18 years and <80 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
The patient must have given written informed consent prior to any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
Please complete the following exclusion criteria.
C0680251 (UMLS CUI-1)
RLS Symptoms
Item
Patients suffering from RLS symptoms during the daytime (daytime defined as 10.00 until 18.00).
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,3])
Sleep disorders
Item
Patients who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (i.e. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
boolean
C0851578 (UMLS CUI [1])
Movement disorders
Item
Patients suffering from movement disorders (i.e. Parkinson’s Disease, dyskinesias, and dystonias).
boolean
C0026650 (UMLS CUI [1])
Comorbidity affecting efficacy
Item
Patients who have medical conditions which could affect assessments of efficacy (i.e. diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome).
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Ropinirole intolerance
Item
Patients who have exhibited intolerance to ropinirole or any other dopamine agonist.
boolean
C1744706 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
Substance abuse/dependence
Item
Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to screening.
boolean
C0038586 (UMLS CUI [1,1])
C0038580 (UMLS CUI [1,2])
Contraception
Item
Women of child-bearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilisation, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant).
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Pregnancy or breast feeding
Item
Women who have a positive pregnancy test or who are lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Unstable medical conditions
Item
Patients who have clinically significant or unstable medical conditions which in the opinion of the investigator would render the patient unsuitable for the study (e.g., symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, etc.).
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Compliance behavior
Item
Patients 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])
C0439801 (UMLS CUI [1,2])
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])
Participation in other clinical trials
Item
Participation in any clinical drug or device trial in the three months prior to the baseline visit.
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Tillbaka till toppen 

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