ID
44018
Description
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)
Mots-clés
Versions (2)
- 04/08/2017 04/08/2017 -
- 20/09/2021 20/09/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
20 septembre 2021
DOI
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Licence
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
Description
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
Description
Date of last RLS medication
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C4029433
- UMLS CUI [1,2]
- C0035258
Description
Last Alcohol Consumption
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C1517741
Description
Alcohol consumption
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001948
Description
Strenuous Exercise
Type de données
boolean
Alias
- UMLS CUI [1]
- C1514989
Description
Smoking Status
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519386
Description
Caffeinated beverage
Type de données
boolean
Alias
- UMLS CUI [1]
- C0678438
Description
OTC or herbal remedies
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013231
- UMLS CUI [2]
- C0025125
Description
Concomitant Medication
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
RLS Rating Scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Description
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Description
If 'YES', please record the medication below. NB: Any medications Metabolised by CYP1A2 must be kept constant through out the study.
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826257
Description
Drug name
Type de données
text
Alias
- UMLS CUI [1]
- C0013227
Description
Dose
Type de données
text
Alias
- UMLS CUI [1]
- C3174092
Description
Medication Frequency
Type de données
text
Alias
- UMLS CUI [1]
- C3476109
Description
Administration Route
Type de données
text
Alias
- UMLS CUI [1]
- C0013153
Description
Duration of Therapy
Type de données
text
Alias
- UMLS CUI [1]
- C0444921
Description
End Date
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Description
Continuing
Type de données
boolean
Alias
- UMLS CUI [1]
- C1553904
Description
Pregnancy Test (Females only)
Alias
- UMLS CUI-1
- C0032976
Description
Pregnancy Test
Type de données
boolean
Alias
- UMLS CUI [1]
- C0032976
Description
Reason for Pregnancy Test
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0032976
Description
Date of Pregnany Test
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032976
Description
If 'POSITIVE', withdraw the subject from the study.
Type de données
text
Alias
- UMLS CUI [1]
- C0427777
Description
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
Description
Date of Examination: Pre-Dose
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826643
- UMLS CUI [1,2]
- C0439565
Description
Time of Examination: Pre-Dose
Type de données
time
Unités de mesure
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0439565
Description
Semi-supine Systolic Blood Pressure: Pre-Dose
Type de données
float
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439565
Description
Semi-supine Diastolic Blood Pressure: Pre-Dose
Type de données
float
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439565
Description
Semi-supine Heart Rate: Pre-Dose
Type de données
float
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439565
Description
Erect Systolic Blood Pressure: Pre-Dose
Type de données
float
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439565
Description
Erect Diastolic Blood Pressure: Pre-Dose
Type de données
float
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439565
Description
Erect Heart Rate: Pre-Dose
Type de données
float
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
Description
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
Description
No Baseline Signs and Symptoms
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1518422
Description
Baseline Signs and Symptoms
Type de données
text
Alias
- UMLS CUI [1]
- C0037088
Description
Date of Onset
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Description
Time of Onset
Type de données
time
Unités de mesure
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Description
End Date of Baseline Signs and Symptoms
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0037088
Description
End Time of Baseline Signs and Symptoms
Type de données
time
Unités de mesure
- 24hr:min
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0037088
Description
* If subject died, please inform GSK within 24 hours and complete Form D
Type de données
text
Alias
- UMLS CUI [1]
- C1547647
Description
Event Course
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
Number of Episodes
Type de données
integer
Alias
- UMLS CUI [1]
- C4086638
Description
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
Type de données
text
Alias
- UMLS CUI [1]
- C0518690
Description
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
Type de données
text
Alias
- UMLS CUI [1]
- C0439849
Description
Corrective Therapy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0087111
Description
Withdrawal
Type de données
boolean
Alias
- UMLS CUI [1]
- C2349954
Description
Dosing Details
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
Description
Afternoon meal
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0439550
- UMLS CUI [1,2]
- C1998602
Description
Date of last food intake
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0578574
- UMLS CUI [1,2]
- C0011008
Description
Time of last food intake
Type de données
time
Unités de mesure
- 24hr:min
Alias
- UMLS CUI [1]
- C0578574
Description
Date of Dosing
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Description
Time of Dosing
Type de données
time
Unités de mesure
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Container Number
Type de données
text
Alias
- UMLS CUI [1]
- C0180098
Description
Label
Type de données
text
Alias
- UMLS CUI [1]
- C0013191
Description
Dose Level
Type de données
text
Alias
- UMLS CUI [1]
- C0178602
Description
Doctor's Name
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0031831
Description
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
Description
Study time: Post-Dose
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0439568
Description
Date of Examination: Post-Dose
Type de données
date
Unités de mesure
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826643
- UMLS CUI [1,2]
- C0439568
Description
Time of Examination: Post-Dose
Type de données
time
Unités de mesure
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0043299
- UMLS CUI [1,3]
- C0439568
Description
Semi-supine Systolic Blood Pressure: Post-Dose
Type de données
float
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Description
Semi-supine Diastolic Blood Pressure: Post-Dose
Type de données
float
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Description
Semi-supine Heart Rate: Post-Dose
Type de données
float
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
Description
Erect Systolic Blood Pressure: Post-Dose
Type de données
float
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
- UMLS CUI [1,3]
- C0439568
Description
Erect Diastolic Blood Pressure: Post-Dose
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
- UMLS CUI [1,3]
- C0439568
Description
Erect Heart Rate: Post-Dose
Type de données
float
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0439568
Description
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
Description
Study Protocol
Alias
- UMLS CUI-1
- C2348563
Description
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.
Type de données
text
Description
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.
Type de données
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])