ID

22382

Description

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 2: Visit 8 (Week 15) RLS Episode 1 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

Keywords

Versions (2)
  1. 6/1/17 6/1/17 -
  2. 6/12/17 6/12/17 -
Uploaded on

June 1, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 2 Visit 8 (Week 15) RLS Episode 1

English

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 2 Visit 8 (Week 15) RLS Episode 1

1 forms  
General Information
Description

General Information

Subject Identifier
Description

Subject Identifier

Data type

text

PRN Subject Diary
Description

PRN Subject Diary

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

Date

Data type

datetime

2. Severity of RLS episode
Description

Severity of RLS episode

Data type

text

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

Did your RLS symptoms disrupt your routine evening activity?

Data type

boolean

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

Severity two hours after medication

Data type

text

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

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

Data type

text

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

Sleep affected by RLS symptoms?

Data type

boolean

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

Specification of RLS symptoms affecting sleep

Data type

boolean

Study Medication
Description

Study Medication

Date study medication taken
Description

Date study medication taken

Data type

date

Time study medication taken
Description

Time study medication taken

Data type

time

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Similar models

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 2 Visit 8 (Week 15) RLS Episode 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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. Severity of RLS episode
text
Severity of RLS episode
Code List
2. Severity of RLS episode
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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