ID

22579

Descripción

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 26: Visit 4 (Week 7) 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

Link

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

Palabras clave

Versiones (2)
  1. 8/6/17 8/6/17 -
  2. 12/6/17 12/6/17 -
Subido en

8 de junio de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

Sin comentarios

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 26: Visit 4 (Week 7) RLS Episode 3

Inglés

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 26: Visit 4 (Week 7) RLS Episode 3

1 formularios  
General Information
Descripción

General Information

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

PRN Subject Diary
Descripción

PRN Subject Diary

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

Date

Tipo de datos

datetime

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

Severity of RLS episode

Tipo de datos

text

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

Did your RLS symptoms disrupt your routine evening activity?

Tipo de datos

boolean

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

Severity two hours after medication

Tipo de datos

text

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

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

Tipo de datos

text

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

Sleep affected by RLS symptoms?

Tipo de datos

boolean

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

Specification of RLS symptoms affecting sleep

Tipo de datos

boolean

Study Medication
Descripción

Study Medication

Date study medication taken
Descripción

Date study medication taken

Tipo de datos

date

Time study medication taken
Descripción

Time study medication taken

Tipo de datos

time

Volver a la parte superior de la página

Similar models

Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 26: Visit 4 (Week 7) RLS Episode 3

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial