ID
36397
Descripción
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 study conclusion form. In this Pregnancy information and Investigators’s Statement are included. The document has to be filled in for the end of study.
Palabras clave
Versiones (3)
- 5/9/17 5/9/17 -
- 10/5/19 10/5/19 -
- 10/5/19 10/5/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
10 de mayo de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201
Study Conclusion (Pregnancy information, Investigators’s Statement)
Descripción
STUDY CONCLUSION
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Descripción
study subject participation status
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2348568
Descripción
Reason, no completion as planned
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1709849
Descripción
Other reason
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3840932
Descripción
reason for withdrawal
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2349954
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2349954
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1531784
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0013227
Descripción
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
Pregnancy during study
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0549206
Descripción
Pregnant Partner in relationship
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0549206
- UMLS CUI [1,2]
- C0682323
Descripción
Statement investigator
Alias
- UMLS CUI-1
- C1710187
- UMLS CUI-2
- C2826892
Descripción
Tick when done
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1283174
Descripción
Tick when done
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1283174
Descripción
Tick when done
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0805732
- UMLS CUI [1,2]
- C1283174
Descripción
Tick when done
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1283174
Descripción
I certify to the best of my knowledge, that the observations and findings are recorded correctly and completely in this CRF.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Study Conclusion (Pregnancy information, Investigators’s Statement)
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0682323 (UMLS CUI [1,2])
C2826892 (UMLS CUI-2)
C1283174 (UMLS CUI [1,2])
C1283174 (UMLS CUI [1,2])
C1283174 (UMLS CUI [1,2])
C1283174 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])