ID

36895

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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 The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the AE/ Concomitant Medication Probe form. It has to be filled in for each study day (Day1-Day19) and for Follow-up.

Mots-clés

  1. 02/09/2017 02/09/2017 -
  2. 19/06/2019 19/06/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

19 juin 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

AE/ Concomitant Medication Probe

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Study Week
Description

Study Week

Type de données

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0439230
Study Day
Description

Please note the study day: Day 1- Day 19, follow-up.

Type de données

text

Unités de mesure
  • day
Alias
UMLS CUI [1]
C2826182
day
AE, Concomitant Medication
Description

AE, Concomitant Medication

Alias
UMLS CUI-1
C2347852
Time relative to start of dose
Description

Note: Pre-dose only is to be queried for Day 1. Timing +24 hrs is to be queried prior to next dose. For Follow-up: There is no specific time.

Type de données

integer

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0178602
Subject asked
Description

If you tick no, please comment in the item "Comment".

Type de données

text

Alias
UMLS CUI [1]
C0566217
Comment
Description

Fill in if subject was not asked.

Type de données

text

Alias
UMLS CUI [1]
C0947611

Similar models

AE/ Concomitant Medication Probe

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study Week
integer
C0008972 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Code List
Study Week
CL Item
Week 1 (1)
CL Item
Week 2 (2)
CL Item
Week 3 (3)
CL Item
Follow-up (4)
Study Day
Item
Study Day
text
C2826182 (UMLS CUI [1])
Item Group
AE, Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Time relative to start of dose
integer
C0040223 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Code List
Time relative to start of dose
CL Item
Pre-dose (1)
CL Item
+2 hrs (2)
CL Item
+6 hrs (3)
CL Item
+16 hrs (4)
CL Item
+24 hrs (5)
Item
Subject asked
text
C0566217 (UMLS CUI [1])
Code List
Subject asked
CL Item
Yes (Y)
CL Item
No (N)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

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