ID
44018
Beskrivning
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)
Nyckelord
Versioner (2)
- 2017-08-04 2017-08-04 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 september 2021
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC-ND 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468
Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Beskrivning
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
Beskrivning
Date of last RLS medication
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C4029433
- UMLS CUI [1,2]
- C0035258
Beskrivning
Last Alcohol Consumption
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C1517741
Beskrivning
Alcohol consumption
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
Strenuous Exercise
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1514989
Beskrivning
Smoking Status
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519386
Beskrivning
Caffeinated beverage
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0678438
Beskrivning
OTC or herbal remedies
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013231
- UMLS CUI [2]
- C0025125
Beskrivning
Concomitant Medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
RLS Rating Scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Beskrivning
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Beskrivning
If 'YES', please record the medication below. NB: Any medications Metabolised by CYP1A2 must be kept constant through out the study.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826257
Beskrivning
Drug name
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Medication Frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Administration Route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Duration of Therapy
Datatyp
text
Alias
- UMLS CUI [1]
- C0444921
Beskrivning
End Date
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Continuing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1553904
Beskrivning
Pregnancy Test (Females only)
Alias
- UMLS CUI-1
- C0032976
Beskrivning
Pregnancy Test
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032976
Beskrivning
Reason for Pregnancy Test
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0032976
Beskrivning
Date of Pregnany Test
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032976
Beskrivning
If 'POSITIVE', withdraw the subject from the study.
Datatyp
text
Alias
- UMLS CUI [1]
- C0427777
Beskrivning
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
Beskrivning
Date of Examination: Pre-Dose
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826643
- UMLS CUI [1,2]
- C0439565
Beskrivning
Time of Examination: Pre-Dose
Datatyp
time
Måttenheter
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0439565
Beskrivning
Semi-supine Systolic Blood Pressure: Pre-Dose
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439565
Beskrivning
Semi-supine Diastolic Blood Pressure: Pre-Dose
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439565
Beskrivning
Semi-supine Heart Rate: Pre-Dose
Datatyp
float
Måttenheter
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439565
Beskrivning
Erect Systolic Blood Pressure: Pre-Dose
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439565
Beskrivning
Erect Diastolic Blood Pressure: Pre-Dose
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439565
Beskrivning
Erect Heart Rate: Pre-Dose
Datatyp
float
Måttenheter
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
Beskrivning
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
Beskrivning
No Baseline Signs and Symptoms
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1518422
Beskrivning
Baseline Signs and Symptoms
Datatyp
text
Alias
- UMLS CUI [1]
- C0037088
Beskrivning
Date of Onset
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Beskrivning
Time of Onset
Datatyp
time
Måttenheter
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Beskrivning
End Date of Baseline Signs and Symptoms
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0037088
Beskrivning
End Time of Baseline Signs and Symptoms
Datatyp
time
Måttenheter
- 24hr:min
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0037088
Beskrivning
* If subject died, please inform GSK within 24 hours and complete Form D
Datatyp
text
Alias
- UMLS CUI [1]
- C1547647
Beskrivning
Event Course
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
Number of Episodes
Datatyp
integer
Alias
- UMLS CUI [1]
- C4086638
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C0518690
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C0439849
Beskrivning
Corrective Therapy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0087111
Beskrivning
Withdrawal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2349954
Beskrivning
Dosing Details
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
Beskrivning
Afternoon meal
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0439550
- UMLS CUI [1,2]
- C1998602
Beskrivning
Date of last food intake
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0578574
- UMLS CUI [1,2]
- C0011008
Beskrivning
Time of last food intake
Datatyp
time
Måttenheter
- 24hr:min
Alias
- UMLS CUI [1]
- C0578574
Beskrivning
Date of Dosing
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Beskrivning
Time of Dosing
Datatyp
time
Måttenheter
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Beskrivning
Container Number
Datatyp
text
Alias
- UMLS CUI [1]
- C0180098
Beskrivning
Label
Datatyp
text
Alias
- UMLS CUI [1]
- C0013191
Beskrivning
Dose Level
Datatyp
text
Alias
- UMLS CUI [1]
- C0178602
Beskrivning
Doctor's Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0031831
Beskrivning
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
Beskrivning
Study time: Post-Dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0439568
Beskrivning
Date of Examination: Post-Dose
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826643
- UMLS CUI [1,2]
- C0439568
Beskrivning
Time of Examination: Post-Dose
Datatyp
time
Måttenheter
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0043299
- UMLS CUI [1,3]
- C0439568
Beskrivning
Semi-supine Systolic Blood Pressure: Post-Dose
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Beskrivning
Semi-supine Diastolic Blood Pressure: Post-Dose
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Beskrivning
Semi-supine Heart Rate: Post-Dose
Datatyp
float
Måttenheter
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
Beskrivning
Erect Systolic Blood Pressure: Post-Dose
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Beskrivning
Erect Diastolic Blood Pressure: Post-Dose
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Beskrivning
Erect Heart Rate: Post-Dose
Datatyp
float
Måttenheter
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
Beskrivning
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
Beskrivning
Study Protocol
Alias
- UMLS CUI-1
- C2348563
Beskrivning
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.
Datatyp
text
Beskrivning
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.
Datatyp
text
Similar models
Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C1707357 (UMLS CUI-2)
C0035258 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C0025125 (UMLS CUI [2])
C0035258 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0032976 (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])
C1518422 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,2])
C0037088 (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])