ID
44018
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 Dose Level 1 (Day 1)
Palabras clave
Versiones (2)
- 4/8/17 4/8/17 -
- 20/9/21 20/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC-ND 3.0
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Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468
Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Descripción
Predose Checklist - Instructions: Please mark appropriateanswer to the following questions. If the answer to all the questions is YES then dosing may proceed.
Alias
- UMLS CUI-1
- C0439565
- UMLS CUI-2
- C1707357
Descripción
Date of last RLS medication
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C4029433
- UMLS CUI [1,2]
- C0035258
Descripción
Last Alcohol Consumption
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C1517741
Descripción
Alcohol consumption
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001948
Descripción
Strenuous Exercise
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1514989
Descripción
Smoking Status
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519386
Descripción
Caffeinated beverage
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0678438
Descripción
OTC or herbal remedies
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0013231
- UMLS CUI [2]
- C0025125
Descripción
Concomitant Medication
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2347852
Descripción
RLS Rating Scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Descripción
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Descripción
If 'YES', please record the medication below. NB: Any medications Metabolised by CYP1A2 must be kept constant through out the study.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826257
Descripción
Drug name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013227
Descripción
Dose
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3174092
Descripción
Medication Frequency
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3476109
Descripción
Administration Route
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013153
Descripción
Duration of Therapy
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0444921
Descripción
End Date
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Descripción
Continuing
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1553904
Descripción
Pregnancy Test (Females only)
Alias
- UMLS CUI-1
- C0032976
Descripción
Pregnancy Test
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0032976
Descripción
Reason for Pregnancy Test
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0032976
Descripción
Date of Pregnany Test
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032976
Descripción
If 'POSITIVE', withdraw the subject from the study.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0427777
Descripción
Vital Signs - Instructions: Semi-supine recordings must be made after the patient has been resting semi-supine for at least 10 min & erect measurments will be taken after the patients has been erect for a period of 1 min. Three sets of stable semi-supine and errect vital signs must be recorded pre-dose with the patient resting fro 10 min semi-supine between each set. In this instance 'stable' is defined at all measurements being within 15 mmHg of the lowest measurements for each and every parameter e.g. semi-supine diastolic. - The blood pressure cuff must be placed on the same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0439565
Descripción
Date of Examination: Pre-Dose
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826643
- UMLS CUI [1,2]
- C0439565
Descripción
Time of Examination: Pre-Dose
Tipo de datos
time
Unidades de medida
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0439565
Descripción
Semi-supine Systolic Blood Pressure: Pre-Dose
Tipo de datos
float
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439565
Descripción
Semi-supine Diastolic Blood Pressure: Pre-Dose
Tipo de datos
float
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439565
Descripción
Semi-supine Heart Rate: Pre-Dose
Tipo de datos
float
Unidades de medida
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439565
Descripción
Erect Systolic Blood Pressure: Pre-Dose
Tipo de datos
float
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439565
Descripción
Erect Diastolic Blood Pressure: Pre-Dose
Tipo de datos
float
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439565
Descripción
Erect Heart Rate: Pre-Dose
Tipo de datos
float
Unidades de medida
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
Descripción
Baseline Signs and Symptoms - Please note any SERIOUS events should be recorded on this page, but on the Serious Adverse Event pages provided. Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to subject: "How do you feel?" Provide the diagnosis, NOT symptoms where possible. (One baseline event per column)
Alias
- UMLS CUI-1
- C0037088
Descripción
No Baseline Signs and Symptoms
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1518422
Descripción
Baseline Signs and Symptoms
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0037088
Descripción
Date of Onset
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Descripción
Time of Onset
Tipo de datos
time
Unidades de medida
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Descripción
End Date of Baseline Signs and Symptoms
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0037088
Descripción
End Time of Baseline Signs and Symptoms
Tipo de datos
time
Unidades de medida
- 24hr:min
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0037088
Descripción
* If subject died, please inform GSK within 24 hours and complete Form D
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1547647
Descripción
Event Course
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Descripción
Number of Episodes
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C4086638
Descripción
MILD = The event which is easily tolerated MODERATE = An event which is sufficiently discomforting to interfere with daily activity SEVERE = An event which prevents normal everyday activities
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0518690
Descripción
NOT RELATED = The event is definetly not related to the study procedures UNLIKELY = There are other more likely causes and the study procedures are not suspected as a cause SUSPECTEED (REASONABLE POSSIBILITY) = A direct cause and effect relationship between the study procedures and the event has not been demonstrated but there is a reasonable possibility that the study procedures were involved PROBABLE = There probably is a direct cause and effect relationship beween and the study procedures
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0439849
Descripción
Corrective Therapy
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
Descripción
Withdrawal
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2349954
Descripción
Dosing Details
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
Descripción
Afternoon meal
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0439550
- UMLS CUI [1,2]
- C1998602
Descripción
Date of last food intake
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0578574
- UMLS CUI [1,2]
- C0011008
Descripción
Time of last food intake
Tipo de datos
time
Unidades de medida
- 24hr:min
Alias
- UMLS CUI [1]
- C0578574
Descripción
Date of Dosing
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Descripción
Time of Dosing
Tipo de datos
time
Unidades de medida
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Descripción
Container Number
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0180098
Descripción
Label
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013191
Descripción
Dose Level
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0178602
Descripción
Doctor's Name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0031831
Descripción
Vital Signs Instructions: For each set, semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measurements will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0439568
Descripción
Study time: Post-Dose
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0439568
Descripción
Date of Examination: Post-Dose
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826643
- UMLS CUI [1,2]
- C0439568
Descripción
Time of Examination: Post-Dose
Tipo de datos
time
Unidades de medida
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0043299
- UMLS CUI [1,3]
- C0439568
Descripción
Semi-supine Systolic Blood Pressure: Post-Dose
Tipo de datos
float
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Descripción
Semi-supine Diastolic Blood Pressure: Post-Dose
Tipo de datos
float
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Descripción
Semi-supine Heart Rate: Post-Dose
Tipo de datos
float
Unidades de medida
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
Descripción
Erect Systolic Blood Pressure: Post-Dose
Tipo de datos
float
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Descripción
Erect Diastolic Blood Pressure: Post-Dose
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Descripción
Erect Heart Rate: Post-Dose
Tipo de datos
float
Unidades de medida
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
Descripción
Adverse Event - Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis NOT symptoms where possible.
Alias
- UMLS CUI-1
- C0877248
Descripción
Study Protocol
Alias
- UMLS CUI-1
- C2348563
Descripción
Y - Ensure patient returns home with their study medication and diary card. N - Select a dosing strategy from options below and tick the relevant box.
Tipo de datos
text
Descripción
TRY AGAIN - Patient will receive the next days dose in the clinic. COmplete an Extra Clinic Visit section of the CRF for this visit. MTD DETERMINED - No further attempts at up titration will be made. Ensure patient returns home with medication for the previous dose level and diary card. Schedule the Last Visit (6 days later) so patients receive their last dose in the clinic. Complete Last Clinic Visit section in the CRF.
Tipo de datos
text
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Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468
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