0 Évaluations
ID

36085

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 (Day 0) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (Day 21) This document contains the prior medication form. It has to be filled in for screening.

Mots-clés

Versions (3)
  1. 15/04/2019 15/04/2019 -
  2. 15/04/2019 15/04/2019 -
  3. 20/09/2021 20/09/2021 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

15 avril 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.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

    Aucun commentaire

    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, 101468/201

    Anglais

    Prior Medication

    1 Formulaires  
    1. StudyEvent: ODM
      1. Prior Medication
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject No.
    Description

    Subject No.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Description

    Panel ID

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Visit Date
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Prior Medication
    Description

    Prior Medication

    Alias
    UMLS CUI-1
    C2826257 (Prior Medication Usage)
    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    Description

    If 'YES', please record the medications below.

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3166216 (Prescribed medications)
    LOINC
    LP124834-5
    UMLS CUI [2]
    C0013231 (Drugs, Non-Prescription)
    DRUG NAME
    Description

    (Trade Name Preferred)

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Single Dose/Unit (e.g.500 mg)
    Description

    Single Dose/Unit

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1960417 (Single dose characteristic)
    SNOMED
    426146003
    Frequency of this Dose (e.g.BID, PR)
    Description

    Frequency of this Dose

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    Route
    Description

    Route

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Indication
    Description

    Indication

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Duration of therapy (e.g.6 years)
    Description

    Duration of therapy

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0444917 (undefined)
    End Date
    Description

    Day/Month/Year

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Continuing at end of study?
    Description

    Continuing at end of study

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1553904 (continuing therapy)
    UMLS CUI [1,2]
    C2983670 (Study End Date)
    Retour au début de la page

    Similar models

    Prior Medication

    1 Formulaires
    1. StudyEvent: ODM
      1. Prior Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Prior Medication
    C2826257 (UMLS CUI-1)
    Prescribed or OTC medication
    Item
    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    boolean
    C3166216 (UMLS CUI [1])
    C0013231 (UMLS CUI [2])
    DRUG NAME
    Item
    DRUG NAME
    text
    C2360065 (UMLS CUI [1])
    Single Dose/Unit
    Item
    Single Dose/Unit (e.g.500 mg)
    text
    C1960417 (UMLS CUI [1])
    Frequency of this Dose
    Item
    Frequency of this Dose (e.g.BID, PR)
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Duration of therapy
    Item
    Duration of therapy (e.g.6 years)
    text
    C0444917 (UMLS CUI [1])
    End Date
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Continuing at end of study
    Item
    Continuing at end of study?
    boolean
    C1553904 (UMLS CUI [1,1])
    C2983670 (UMLS CUI [1,2])
    Retour au début de la page 

    Aide

    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