ID

36873

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 Eligibility Review. It has to be filled in prior to dosing Day 1.

Mots-clés

  1. 01/09/2017 01/09/2017 -
  2. 18/06/2019 18/06/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

18 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

Eligibility Review

  1. StudyEvent: ODM
    1. Eligibility Review
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Description

Volunteer panel number

Type de données

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Description

Subject number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Eligibility Review
Description

Eligibility Review

Alias
UMLS CUI-1
C0013893
UMLS CUI-2
C3166277
Has subject met all inclusion/exclusion criteria?
Description

If you tick No, please comment in the Item "Comment".

Type de données

text

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C3166277
Is subject suitable for inclusion?
Description

If you tick No, please comment in the Item "Comment".

Type de données

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0332149
Is subject included?
Description

If you tick No, please comment in the Item "Comment".

Type de données

text

Alias
UMLS CUI [1]
C2348568
Comment
Description

Fill in if you ticked "No" in prior items.

Type de données

text

Alias
UMLS CUI [1]
C0947611
Investigator
Description

Investigator

Type de données

text

Alias
UMLS CUI [1]
C2826892
Date
Description

day month year

Type de données

date

Alias
UMLS CUI [1]
C0011008

Similar models

Eligibility Review

  1. StudyEvent: ODM
    1. Eligibility Review
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Volunteer panel number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Eligibility Review
C0013893 (UMLS CUI-1)
C3166277 (UMLS CUI-2)
Item
Has subject met all inclusion/exclusion criteria?
text
C0013893 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
Code List
Has subject met all inclusion/exclusion criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is subject suitable for inclusion?
text
C1512693 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Code List
Is subject suitable for inclusion?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is subject included?
text
C2348568 (UMLS CUI [1])
Code List
Is subject included?
CL Item
Yes (Y)
CL Item
No (N)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (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