ID

22580

Beschrijving

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 27: Visit 4 (Week 7) RLS Episode 4 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

Trefwoorden

Versies (2)
  1. 08-06-17 08-06-17 -
  2. 12-06-17 12-06-17 -
Geüploaded op

8 juni 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 27: Visit 4 (Week 7) RLS Episode 4

Engels

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 27: Visit 4 (Week 7) RLS Episode 4

1 Formulieren  
General Information
Beschrijving

General Information

Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

PRN Subject Diary
Beschrijving

PRN Subject Diary

1. Enter the date and time your RLs symptoms started.
Beschrijving

Date

Datatype

datetime

2. How severe were your RLS symptoms at the time you took the dose of study medication?
Beschrijving

Severity of RLS episode

Datatype

text

3. Did your RLS symptoms disrupt your routine evening activity?
Beschrijving

Did your RLS symptoms disrupt your routine evening activity?

Datatype

boolean

4. How severe were your RLS symptoms 2 hours after taking the study medication?
Beschrijving

Severity two hours after medication

Datatype

text

5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
Beschrijving

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

Datatype

text

6. Overall, did your RLS symptoms affect your sleep last night?
Beschrijving

Sleep affected by RLS symptoms?

Datatype

boolean

If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
Beschrijving

Specification of RLS symptoms affecting sleep

Datatype

boolean

Study Medication
Beschrijving

Study Medication

Date study medication taken
Beschrijving

Date study medication taken

Datatype

date

Time study medication taken
Beschrijving

Time study medication taken

Datatype

time

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Similar models

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 27: Visit 4 (Week 7) RLS Episode 4

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General Information
Subject Identifier
Item
Subject Identifier
text
Item Group
PRN Subject Diary
Date
Item
1. Enter the date and time your RLs symptoms started.
datetime
Item
2. How severe were your RLS symptoms at the time you took the dose of study medication?
text
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
Item
4. How severe were your RLS symptoms 2 hours after taking the study medication?
text
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
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
Specification of RLS symptoms affecting sleep
Item
If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
boolean
Item Group
Study Medication
Date study medication taken
Item
Date study medication taken
date
Time study medication taken
Item
Time study medication taken
time
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