ID
24241
Descrição
Part 2 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
Palavras-chave
Versões (1)
- 27/07/2017 27/07/2017 -
Titular dos direitos
GlaxoSmithKline
Transferido a
27 de julho de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Day 2
GSK study: Ropinirole in RLS patients 101468/243 - Day 2
- StudyEvent: ODM
Descrição
RLS Rating Scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Descrição
Vital signs
Alias
- UMLS CUI-1
- C0518766
Descrição
after 5min sitting
Tipo de dados
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Descrição
after 5 minutes sitting
Tipo de dados
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Descrição
after 5 min sitting
Tipo de dados
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Descrição
Medical Procedures
Alias
- UMLS CUI-1
- C0199171
Descrição
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Descrição
Adverse experience
Alias
- UMLS CUI-1
- C0559546
Descrição
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
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0559546
Descrição
Instructions for the investigator
Alias
- UMLS CUI-1
- C0302828
- UMLS CUI-2
- C0035173
Descrição
Guided by the CGI Efficacy Index (below) determine dose level to be dispensed and dispense Week 1 (Days 3 - 7) study medication. 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 5 days for the Week 1 clinic visit. * 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.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0302828
- UMLS CUI [1,2]
- C0035173
Descrição
Clinical Global impression
Alias
- UMLS CUI-1
- C3639708
Similar models
GSK study: Ropinirole in RLS patients 101468/243 - Day 2
- StudyEvent: ODM
C0008972 (UMLS CUI-2)
C0008972 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0035173 (UMLS CUI-2)
C0035173 (UMLS CUI [1,2])