ID

22817

Beskrivning

Study ID: 100310 Clinical Study ID: RRL100310 Study Title: A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS) Part 15: Visit 3 (Week 5) RLS Episode 3 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00225862 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 More details on: https://clinicaltrials.gov/ct2/show/NCT00225862

Länk

https://clinicaltrials.gov/ct2/show/NCT00225862

Nyckelord

Versioner (2)
  1. 2017-06-08 2017-06-08 -
  2. 2017-06-12 2017-06-12 -
Uppladdad den

12 juni 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 15: Visit 3 (Week 5) RLS Episode 3

Engelsk

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 15: Visit 3 (Week 5) RLS Episode 3

1 Formulär  
General Information
Beskrivning

General Information

Alias
UMLS CUI-1
C1508263
UMLS CUI-2
C1955348
UMLS CUI-3
C0035258
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
PRN Subject Diary
Beskrivning

PRN Subject Diary

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0035258
1. Enter the date and time your RLs symptoms started.
Beskrivning

Date

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0035258
UMLS CUI [1,4]
C1457887
2. How severe were your RLS symptoms at the time you took the dose of study medication?
Beskrivning

Severity of RLS episode

Datatyp

text

Alias
UMLS CUI [1,1]
C0439793
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C1457887
UMLS CUI [2]
C0013227
3. Did your RLS symptoms disrupt your routine evening activity?
Beskrivning

Did your RLS symptoms disrupt your routine evening activity?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332453
UMLS CUI [1,2]
C0001288
UMLS CUI [1,3]
C0035258
4. How severe were your RLS symptoms 2 hours after taking the study medication?
Beskrivning

Severity two hours after medication

Datatyp

text

Alias
UMLS CUI [1,1]
C0439793
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0035258
UMLS CUI [2]
C0013227
5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
Beskrivning

Read the following and complete the questions when you wake up next morning.

Datatyp

text

Alias
UMLS CUI [1,1]
C1515926
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0035258
UMLS CUI [2]
C0013227
6. Overall, did your RLS symptoms affect your sleep last night?
Beskrivning

Sleep affected by RLS symptoms?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037313
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0035258
If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
Beskrivning

Specification of RLS symptoms affecting sleep

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0393760
UMLS CUI [1,2]
C0037317
UMLS CUI [1,3]
C0035258
Study Medication
Beskrivning

Study Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0304229
UMLS CUI-3
C0008976
UMLS CUI-4
C0035258
Date study medication taken
Beskrivning

Date study medication taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013227
Time study medication taken
Beskrivning

Time study medication taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
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Similar models

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 15: Visit 3 (Week 5) RLS Episode 3

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
PRN Subject Diary
C3890583 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
Date
Item
1. Enter the date and time your RLs symptoms started.
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item
2. How severe were your RLS symptoms at the time you took the dose of study medication?
text
C0439793 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
Severity of RLS episode
Code List
2. How severe were your RLS symptoms at the time you took the dose of study medication?
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Did your RLS symptoms disrupt your routine evening activity?
Item
3. Did your RLS symptoms disrupt your routine evening activity?
boolean
C0332453 (UMLS CUI [1,1])
C0001288 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item
4. How severe were your RLS symptoms 2 hours after taking the study medication?
text
C0439793 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
Severity two hours after medication
Code List
4. How severe were your RLS symptoms 2 hours after taking the study medication?
CL Item
I was asleep at 2 hours after taking the last dose  (1)
CL Item
None (2)
CL Item
Mild (3)
CL Item
Moderate (4)
CL Item
Severe (5)
CL Item
Very Severe (6)
Item
5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
text
C1515926 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
Change in RLS symptoms after dosing the night before
Code List
5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
CL Item
Very much improved (Complete symptom relief) (1)
CL Item
Much improved (Good symptom relief) (2)
CL Item
Minimally improved (Some symptom relief) (3)
CL Item
No change (4)
CL Item
Minimally worse (Symptoms minimally worse) (5)
CL Item
Much worse (Symptoms much worse) (6)
CL Item
Very much worse (Symptoms very much worse) (7)
Sleep affected by RLS symptoms?
Item
6. Overall, did your RLS symptoms affect your sleep last night?
boolean
C0037313 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Specification of RLS symptoms affecting sleep
Item
If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
boolean
C0393760 (UMLS CUI [1,1])
C0037317 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item Group
Study Medication
C0013227 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C0035258 (UMLS CUI-4)
Date study medication taken
Item
Date study medication taken
date
C0011008 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Time study medication taken
Item
Time study medication taken
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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