ID
44018
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 Dose Level 1 (Day 1)
Trefwoorden
Versies (2)
- 04-08-17 04-08-17 -
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC-ND 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468
Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Beschrijving
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
Beschrijving
Date of last RLS medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C4029433
- UMLS CUI [1,2]
- C0035258
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
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Beschrijving
If 'YES', please record the medication below. NB: Any medications Metabolised by CYP1A2 must be kept constant through out the study.
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826257
Beschrijving
Drug name
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Dose
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Medication Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Administration Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Duration of Therapy
Datatype
text
Alias
- UMLS CUI [1]
- C0444921
Beschrijving
End Date
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Continuing
Datatype
boolean
Alias
- UMLS CUI [1]
- C1553904
Beschrijving
Pregnancy Test (Females only)
Alias
- UMLS CUI-1
- C0032976
Beschrijving
Pregnancy Test
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Reason for Pregnancy Test
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0032976
Beschrijving
Date of Pregnany Test
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032976
Beschrijving
If 'POSITIVE', withdraw the subject from the study.
Datatype
text
Alias
- UMLS CUI [1]
- C0427777
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
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
Beschrijving
No Baseline Signs and Symptoms
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1518422
Beschrijving
Baseline Signs and Symptoms
Datatype
text
Alias
- UMLS CUI [1]
- C0037088
Beschrijving
Date of Onset
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Time of Onset
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Beschrijving
End Date of Baseline Signs and Symptoms
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0037088
Beschrijving
End Time of Baseline Signs and Symptoms
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0037088
Beschrijving
* If subject died, please inform GSK within 24 hours and complete Form D
Datatype
text
Alias
- UMLS CUI [1]
- C1547647
Beschrijving
Event Course
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
Number of Episodes
Datatype
integer
Alias
- UMLS CUI [1]
- C4086638
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1]
- C0518690
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1]
- C0439849
Beschrijving
Corrective Therapy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0087111
Beschrijving
Withdrawal
Datatype
boolean
Alias
- UMLS CUI [1]
- C2349954
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
Erect Systolic Blood Pressure: Post-Dose
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Beschrijving
Erect Diastolic Blood Pressure: Post-Dose
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Beschrijving
Erect Heart Rate: Post-Dose
Datatype
float
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
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
Beschrijving
Study Protocol
Alias
- UMLS CUI-1
- C2348563
Beschrijving
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.
Datatype
text
Beschrijving
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.
Datatype
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])