ID

24245

Description

Part 6 of Module 3 - Baseline, Day 2, Wk 1-8-Cont/Wthd 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Keywords

Versions (1)
  1. 7/27/17 7/27/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

July 27, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Week 4

English

GSK study: Ropinirole in RLS patients 101468/243 - Week 4

1 forms  
Study medication record since last visit
Description

Study medication record since last visit

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
Study medication record since last visit
Description

Please complete the study medication record in the Study Medication and Compliance Section at the back of this module.

Data type

text

Alias
UMLS CUI [1,1]
C2734539
UMLS CUI [1,2]
C0008972
RLS Rating Scale
Description

RLS Rating Scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
RLS Rating Scale
Description

Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Pulse
Description

after 5min sitting

Data type

integer

Measurement units
  • betas/min
Alias
UMLS CUI [1]
C0232117
betas/min
Sitting systolic blood pressure
Description

after 5 minutes sitting

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting diastolic blood pressure
Description

Sitting diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Medical Procedures
Description

Medical Procedures

Alias
UMLS CUI-1
C0199171
Medical Procedures
Description

Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this module

Data type

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant medication
Description

Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this module

Data type

text

Alias
UMLS CUI [1]
C2347852
Adverse reaction
Description

Adverse reaction

Alias
UMLS CUI-1
C0559546
Adverse reaction
Description

Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience section at the back of this module

Data type

text

Alias
UMLS CUI [1]
C0559546
Instructions for the investigator
Description

Instructions for the investigator

Alias
UMLS CUI-1
C0302828
UMLS CUI-2
C0035173
Instructions for the investigator
Description

Guided by the CGI Efficacy Index (below) determine dose level to be dispensed and dispense appropriate study medication (depending on whether patient is omitting Weeks 5, 6 and 7). Complete the Study Medication and Compliance Section at the back of this module. If the patient’s dose has been increased at this clinic visit: a) Instruct the patient to return to the clinic this evening or remain to perform orthostatic vital signs*: - 2 sets of pre-dose orthostatic blood pressure and pulse - Patient takes evening dose in the clinic - One set of 2 hour post-dose orthostatic blood pressure and pulse Instruct the patient to take the appropriate number of tablet(s), at the same time, no earlier than 3 hours prior to and no later than one hour prior to bedtime (except on the first night of each new dose increase). Patient must return the bottle(s) with any unused medication at the next visit. Arrange for the patient to return in 7 days (plus or minus 3 days) for the Week 5 clinic visit, if the Week 5 visit is required. If Week 5, 6 and 7 are not required, please arrange for the patient to return for the Week 8 Visit in 28 days. * Where possible this visit should be performed in the evening with dosing approximately 8:00 P.M. However, for scheduling convenience, this visit (including dosing) may occur during the afternoon hours (as late in the day as possible) to accomodate the collection of orthostatic blood pressure/pulse assessments during the normal clinic hours.

Data type

text

Alias
UMLS CUI [1,1]
C0302828
UMLS CUI [1,2]
C0035173
Clinical Global impression
Description

Clinical Global impression

Alias
UMLS CUI-1
C3639708
Clinical global impression
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

text

Alias
UMLS CUI [1]
C3639708
Dose reduction
Description

Dose reduction

Alias
UMLS CUI-1
C1707814
Dose Reduction
Description

If the patient requires a dose reduction between this and the next visit please complete Dose Reductions Due To Adverse Experiences pages at the back of this module. Dosage reduction may occur between scheduled clinic visits, if necessary. The subject will be instructed to contact the site to arrange a visit should a dose decrease become necessary outside of the regularly specified protocol visit.

Data type

text

Alias
UMLS CUI [1]
C1707814
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Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Week 4

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study medication record since last visit
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study medication record since last visit
Item
Study medication record since last visit
text
C2734539 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Item Group
RLS Rating Scale
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS Rating Scale
Item
RLS Rating Scale
text
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting systolic blood pressure
Item
Sitting systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting diastolic blood pressure
Item
Sitting diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Medical Procedures
C0199171 (UMLS CUI-1)
Medical Procedures
Item
Medical Procedures
text
C0199171 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant medication
Item
Concomitant medication
text
C2347852 (UMLS CUI [1])
Item Group
Adverse reaction
C0559546 (UMLS CUI-1)
Adverse reaction
Item
Adverse reaction
text
C0559546 (UMLS CUI [1])
Item Group
C0302828 (UMLS CUI-1)
C0035173 (UMLS CUI-2)
Instructions for the investigator
Item
Instructions for the investigator
text
C0302828 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
Item Group
Clinical Global impression
C3639708 (UMLS CUI-1)
Clinical global impression
Item
Clinical global impression
text
C3639708 (UMLS CUI [1])
Item Group
Dose reduction
C1707814 (UMLS CUI-1)
Dose Reduction
Item
Dose Reduction
text
C1707814 (UMLS CUI [1])
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