ID
44018
Beschreibung
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)
Stichworte
Versionen (2)
- 04.08.17 04.08.17 -
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
20. September 2021
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC-ND 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468
Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Beschreibung
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
Beschreibung
Date of last RLS medication
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C4029433
- UMLS CUI [1,2]
- C0035258
Beschreibung
Last Alcohol Consumption
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C1517741
Beschreibung
Alcohol consumption
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
Strenuous Exercise
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1514989
Beschreibung
Smoking Status
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519386
Beschreibung
Caffeinated beverage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0678438
Beschreibung
OTC or herbal remedies
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013231
- UMLS CUI [2]
- C0025125
Beschreibung
Concomitant Medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
RLS Rating Scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Beschreibung
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Beschreibung
If 'YES', please record the medication below. NB: Any medications Metabolised by CYP1A2 must be kept constant through out the study.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826257
Beschreibung
Drug name
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Dose
Datentyp
text
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Medication Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Administration Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Duration of Therapy
Datentyp
text
Alias
- UMLS CUI [1]
- C0444921
Beschreibung
End Date
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Continuing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1553904
Beschreibung
Pregnancy Test (Females only)
Alias
- UMLS CUI-1
- C0032976
Beschreibung
Pregnancy Test
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
Reason for Pregnancy Test
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0032976
Beschreibung
Date of Pregnany Test
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032976
Beschreibung
If 'POSITIVE', withdraw the subject from the study.
Datentyp
text
Alias
- UMLS CUI [1]
- C0427777
Beschreibung
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
Beschreibung
Date of Examination: Pre-Dose
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826643
- UMLS CUI [1,2]
- C0439565
Beschreibung
Time of Examination: Pre-Dose
Datentyp
time
Maßeinheiten
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0439565
Beschreibung
Semi-supine Systolic Blood Pressure: Pre-Dose
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439565
Beschreibung
Semi-supine Diastolic Blood Pressure: Pre-Dose
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439565
Beschreibung
Semi-supine Heart Rate: Pre-Dose
Datentyp
float
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439565
Beschreibung
Erect Systolic Blood Pressure: Pre-Dose
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439565
Beschreibung
Erect Diastolic Blood Pressure: Pre-Dose
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439565
Beschreibung
Erect Heart Rate: Pre-Dose
Datentyp
float
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
Beschreibung
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
Beschreibung
No Baseline Signs and Symptoms
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1518422
Beschreibung
Baseline Signs and Symptoms
Datentyp
text
Alias
- UMLS CUI [1]
- C0037088
Beschreibung
Date of Onset
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
Time of Onset
Datentyp
time
Maßeinheiten
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Beschreibung
End Date of Baseline Signs and Symptoms
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0037088
Beschreibung
End Time of Baseline Signs and Symptoms
Datentyp
time
Maßeinheiten
- 24hr:min
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0037088
Beschreibung
* If subject died, please inform GSK within 24 hours and complete Form D
Datentyp
text
Alias
- UMLS CUI [1]
- C1547647
Beschreibung
Event Course
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschreibung
Number of Episodes
Datentyp
integer
Alias
- UMLS CUI [1]
- C4086638
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1]
- C0518690
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1]
- C0439849
Beschreibung
Corrective Therapy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0087111
Beschreibung
Withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349954
Beschreibung
Dosing Details
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
Beschreibung
Afternoon meal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0439550
- UMLS CUI [1,2]
- C1998602
Beschreibung
Date of last food intake
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0578574
- UMLS CUI [1,2]
- C0011008
Beschreibung
Time of last food intake
Datentyp
time
Maßeinheiten
- 24hr:min
Alias
- UMLS CUI [1]
- C0578574
Beschreibung
Date of Dosing
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Beschreibung
Time of Dosing
Datentyp
time
Maßeinheiten
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Beschreibung
Container Number
Datentyp
text
Alias
- UMLS CUI [1]
- C0180098
Beschreibung
Label
Datentyp
text
Alias
- UMLS CUI [1]
- C0013191
Beschreibung
Dose Level
Datentyp
text
Alias
- UMLS CUI [1]
- C0178602
Beschreibung
Doctor's Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0031831
Beschreibung
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
Beschreibung
Study time: Post-Dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0439568
Beschreibung
Date of Examination: Post-Dose
Datentyp
date
Maßeinheiten
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826643
- UMLS CUI [1,2]
- C0439568
Beschreibung
Time of Examination: Post-Dose
Datentyp
time
Maßeinheiten
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0043299
- UMLS CUI [1,3]
- C0439568
Beschreibung
Semi-supine Systolic Blood Pressure: Post-Dose
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Beschreibung
Semi-supine Diastolic Blood Pressure: Post-Dose
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Beschreibung
Semi-supine Heart Rate: Post-Dose
Datentyp
float
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
Beschreibung
Erect Systolic Blood Pressure: Post-Dose
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Beschreibung
Erect Diastolic Blood Pressure: Post-Dose
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Beschreibung
Erect Heart Rate: Post-Dose
Datentyp
float
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
Beschreibung
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
Beschreibung
Study Protocol
Alias
- UMLS CUI-1
- C2348563
Beschreibung
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.
Datentyp
text
Beschreibung
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.
Datentyp
text
Ähnliche Modelle
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])