ID
25699
Beschrijving
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 Last Clinic Visit (Day 49)
Trefwoorden
Versies (1)
- 11-09-17 11-09-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
11 september 2017
DOI
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Licentie
Creative Commons BY-NC-ND 3.0
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Last Clinic Visit GSK Ropinirole Restless Legs Syndrome 101468
Last Clinic Visit GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Beschrijving
Predose Checklist - Instructions: Please mark appropriate answer 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
Beschrijving
Last Alcohol Consumption
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C1517741
Beschrijving
Alcohol consumption
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
Strenuous Exercise
Datatype
boolean
Alias
- UMLS CUI [1]
- C1514989
Beschrijving
Smoking Status
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519386
Beschrijving
Caffeinated beverage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0678438
Beschrijving
OTC or herbal remedies
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013231
- UMLS CUI [2]
- C0025125
Beschrijving
Concomitant Medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
RLS Rating Scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Beschrijving
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
Beschrijving
Date of Examination: Pre-Dose
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826643
- UMLS CUI [1,2]
- C0439565
Beschrijving
Time of Examination: Pre-Dose
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0439565
Beschrijving
Semi-supine Systolic Blood Pressure: Pre-Dose
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439565
Beschrijving
Semi-supine Diastolic Blood Pressure: Pre-Dose
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439565
Beschrijving
Semi-supine Heart Rate: Pre-Dose
Datatype
float
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439565
Beschrijving
Erect Systolic Blood Pressure: Pre-Dose
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439565
Beschrijving
Erect Diastolic Blood Pressure: Pre-Dose
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439565
Beschrijving
Erect Heart Rate: Pre-Dose
Datatype
float
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
Beschrijving
Dosing Details
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
Beschrijving
Afternoon meal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0439550
- UMLS CUI [1,2]
- C1998602
Beschrijving
Date of last food intake
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0578574
- UMLS CUI [1,2]
- C0011008
Beschrijving
Time of last food intake
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1]
- C0578574
Beschrijving
Date of Dosing
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Beschrijving
Time of Dosing
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Beschrijving
Container Number
Datatype
text
Alias
- UMLS CUI [1]
- C0180098
Beschrijving
Label
Datatype
text
Alias
- UMLS CUI [1]
- C0013191
Beschrijving
Dose Level
Datatype
text
Alias
- UMLS CUI [1]
- C0178602
Beschrijving
Doctor's Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0031831
Beschrijving
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
Beschrijving
Study time: Post-Dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0439568
Beschrijving
Date of Examination: Post-Dose
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826643
- UMLS CUI [1,2]
- C0439568
Beschrijving
Time of Examination: Post-Dose
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0043299
- UMLS CUI [1,3]
- C0439568
Beschrijving
Semi-supine Systolic Blood Pressure: Post-Dose
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Beschrijving
Semi-supine Diastolic Blood Pressure: Post-Dose
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Beschrijving
Semi-supine Heart Rate: Post-Dose
Datatype
float
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
Beschrijving
Repeat the erect measurements IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Beschrijving
Repeat the erect measurements IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Beschrijving
Repeat the erect measurements IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.
Datatype
float
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
Beschrijving
Alert Criteria
Datatype
text
Alias
- UMLS CUI [1,1]
- C3665546
- UMLS CUI [1,2]
- C0243161
Beschrijving
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
Similar models
Last Clinic Visit GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C1707357 (UMLS CUI-2)
C1517741 (UMLS CUI [1,2])
C0025125 (UMLS CUI [2])
C0035258 (UMLS CUI [1,2])
C0439565 (UMLS CUI-2)
C0439565 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0871470 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0428883 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0871470 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0428883 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C1998602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])
C0439568 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,2])
C0043299 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0871470 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0428883 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0871470 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0428883 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,2])
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