ID
36397
Beschreibung
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.
Stichworte
Versionen (3)
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- 10.05.19 10.05.19 -
- 10.05.19 10.05.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
10. Mai 2019
DOI
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Lizenz
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)
Beschreibung
STUDY CONCLUSION
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschreibung
study subject participation status
Datentyp
text
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
Reason, no completion as planned
Datentyp
integer
Alias
- UMLS CUI [1]
- C1709849
Beschreibung
Other reason
Datentyp
text
Alias
- UMLS CUI [1]
- C3840932
Beschreibung
reason for withdrawal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2349954
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2349954
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1531784
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0013227
Beschreibung
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschreibung
Pregnancy during study
Datentyp
text
Alias
- UMLS CUI [1]
- C0549206
Beschreibung
Pregnant Partner in relationship
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0549206
- UMLS CUI [1,2]
- C0682323
Beschreibung
Statement investigator
Alias
- UMLS CUI-1
- C1710187
- UMLS CUI-2
- C2826892
Beschreibung
Tick when done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1283174
Beschreibung
Tick when done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1283174
Beschreibung
Tick when done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0805732
- UMLS CUI [1,2]
- C1283174
Beschreibung
Tick when done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1283174
Beschreibung
I certify to the best of my knowledge, that the observations and findings are recorded correctly and completely in this CRF.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
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])