ID

29087

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

Assessment Early Withdrawal

1 Formulär  
Administration
Beskrivning

Administration

Alias
UMLS CUI-1
C1320722
Patient number
Beskrivning

Patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Visit date
Beskrivning

Visit date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Center Number
Beskrivning

Center Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
IRLS Rating Scale
Beskrivning

IRLS Rating Scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
Please complete the IRLS Rating Scale
Beskrivning

IRLS Rating Scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale. • Hospital Anxiety and Depression Scale (HADS). • Patient Satisfaction Question.
Beskrivning

Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale. • Hospital Anxiety and Depression Scale (HADS). • Patient Satisfaction Question.

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0035258
UMLS CUI-3
C0679830
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Weight (without shoes)
Beskrivning

Weight

Datatyp

integer

Måttenheter
  • kg / lbs
Alias
UMLS CUI [1]
C0005910
kg / lbs
Orthostatic vital signs
Beskrivning

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Orthostatic vital signs
Beskrivning

Orthostatic vital signs

Datatyp

integer

Alias
UMLS CUI [1]
C0518766
Time Vitals Taken
Beskrivning

Time Vitals Taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Blood pressure systolic/diastolic
Beskrivning

Blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse
Beskrivning

Pulse

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Beskrivning

Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.

Alias
UMLS CUI-1
C0199171
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
Beskrivning

Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.

Alias
UMLS CUI-1
C2347852
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
Beskrivning

Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.

Alias
UMLS CUI-1
C0877248
Clinical Global Impressions
Beskrivning

Clinical Global Impressions

Alias
UMLS CUI-1
C3639708
Laboratory evaluation
Beskrivning

Laboratory evaluation

Alias
UMLS CUI-1
C0022885
Date of blood sample:
Beskrivning

Date of blood sample

Datatyp

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Were any clinically significant abnormalities detected?
Beskrivning

If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Follow-up.

Datatyp

boolean

Alias
UMLS CUI [1]
C1853129
Is the patient a female of child-bearing potential?
Beskrivning

If ’Yes’, please perform a pregnancy dipstick test and record result below.

Datatyp

boolean

Alias
UMLS CUI [1]
C0430056
Pregnancy?
Beskrivning

If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Followup.

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
Dose and Meal Information
Beskrivning

Dose and Meal Information

Alias
UMLS CUI-1
C3174092
UMLS CUI-2
C1998602
UMLS CUI-3
C0034869
Time of last dose of study medication prior to the Early Withdrawal Visit:
Beskrivning

Last dose of study medication

Datatyp

text

Alias
UMLS CUI [1]
C0946444
Date and time of last meal prior to Early Withdrawal Visit:
Beskrivning

Date and time of last meal

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0578574
UMLS CUI [1,2]
C0011008
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Similar models

Assessment Early Withdrawal

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
IRLS Rating Scale
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
IRLS Rating Scale
Item
Please complete the IRLS Rating Scale
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale. • Hospital Anxiety and Depression Scale (HADS). • Patient Satisfaction Question.
C0034394 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
C0679830 (UMLS CUI-3)
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight (without shoes)
integer
C0005910 (UMLS CUI [1])
Item Group
Orthostatic vital signs
C0518766 (UMLS CUI-1)
Item
Orthostatic vital signs
integer
C0518766 (UMLS CUI [1])
Orthostatic vital signs
Code List
Orthostatic vital signs
CL Item
After 10 minutes semi-supine (1)
CL Item
After erect for 1 minute (2)
Time Vitals Taken
Item
Time Vitals Taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure
Item
Blood pressure systolic/diastolic
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
C0199171 (UMLS CUI-1)
Item Group
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
C2347852 (UMLS CUI-1)
Item Group
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
C0877248 (UMLS CUI-1)
Item Group
Clinical Global Impressions
C3639708 (UMLS CUI-1)
Item Group
Laboratory evaluation
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample:
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory abnormalities
Item
Were any clinically significant abnormalities detected?
boolean
C1853129 (UMLS CUI [1])
Pregnancy dipstick
Item
Is the patient a female of child-bearing potential?
boolean
C0430056 (UMLS CUI [1])
Pregnancy
Item
Pregnancy?
boolean
C0032961 (UMLS CUI [1])
Item Group
Dose and Meal Information
C3174092 (UMLS CUI-1)
C1998602 (UMLS CUI-2)
C0034869 (UMLS CUI-3)
Last dose of study medication
Item
Time of last dose of study medication prior to the Early Withdrawal Visit:
text
C0946444 (UMLS CUI [1])
Date and time of last meal
Item
Date and time of last meal prior to Early Withdrawal Visit:
datetime
C0578574 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Tillbaka till toppen 

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