ID

22814

Beschreibung

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 20: Visit 3 (Week 5) RLS Episode 8 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

Link

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

Stichworte

Versionen (2)
  1. 08.06.17 08.06.17 -
  2. 12.06.17 12.06.17 -
Hochgeladen am

12. Juni 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 20: Visit 3 (Week 5) RLS Episode 8

Englisch

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 20: Visit 3 (Week 5) RLS Episode 8

1 Formulare  
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263 (General information section)
LOINC
MTHU015719
UMLS CUI-2
C1955348 (Patient Information)
UMLS CUI-3
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
PRN Subject Diary
Beschreibung

PRN Subject Diary

Alias
UMLS CUI-1
C3890583 (Subject Diary)
UMLS CUI-2
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
1. Enter the date and time your RLs symptoms started.
Beschreibung

Date

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008 (Date in time)
SNOMED
410671006
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
UMLS CUI [1,3]
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
UMLS CUI [1,4]
C0332189 (Episode of)
SNOMED
263503000
2. How severe were your RLS symptoms at the time you took the dose of study medication?
Beschreibung

Severity of RLS episode

Datentyp

text

Alias
UMLS CUI [1,1]
C0439793 (Severities)
SNOMED
272141005
UMLS CUI [1,2]
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
UMLS CUI [1,3]
C0332189 (Episode of)
SNOMED
263503000
3. Did your RLS symptoms disrupt your routine evening activity?
Beschreibung

Did your RLS symptoms disrupt your routine evening activity?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332453 (Disruption)
SNOMED
76555007
LOINC
LA19648-7
UMLS CUI [1,2]
C0001288 (Activities of Daily Living (activity))
SNOMED
129025006
LOINC
LP57620-4
UMLS CUI [1,3]
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
4. How severe were your RLS symptoms 2 hours after taking the study medication?
Beschreibung

Severity two hours after medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0439793 (Severities)
SNOMED
272141005
UMLS CUI [1,2]
C1457887 (Symptoms)
LOINC
MTHU021540
UMLS CUI [1,3]
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
UMLS CUI [2]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C1515926 (Alteration)
UMLS CUI [1,2]
C1457887 (Symptoms)
LOINC
MTHU021540
UMLS CUI [1,3]
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
UMLS CUI [2]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
6. Overall, did your RLS symptoms affect your sleep last night?
Beschreibung

Sleep affected by RLS symptoms?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037313 (Sleep)
SNOMED
258158006
LOINC
LA18125-7
UMLS CUI [1,2]
C0392760 (Affecting)
SNOMED
247591002
UMLS CUI [1,3]
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
Beschreibung

Specification of RLS symptoms affecting sleep

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0393760 (Initial insomnia)
SNOMED
59050008
LOINC
LP121706-8
UMLS CUI [1,2]
C0037317 (Sleep disturbances)
SNOMED
53888004
UMLS CUI [1,3]
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
Study Medication
Beschreibung

Study Medication

Alias
UMLS CUI-1
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI-2
C0304229 (Experimental drug)
UMLS CUI-3
C0008976 (Clinical Trials)
SNOMED
110465008
LOINC
LP231796-6
UMLS CUI-4
C0035258 (Restless Legs Syndrome)
SNOMED
32914008
Date study medication taken
Beschreibung

Date study medication taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008 (Date in time)
SNOMED
410671006
UMLS CUI [1,2]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
Time study medication taken
Beschreibung

Time study medication taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
UMLS CUI [1,2]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
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Ähnliche Modelle

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 20: Visit 3 (Week 5) RLS Episode 8

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
C0332189 (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])
C0332189 (UMLS CUI [1,3])
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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