ID
36397
Beschrijving
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.
Trefwoorden
Versies (3)
- 05-09-17 05-09-17 -
- 10-05-19 10-05-19 -
- 10-05-19 10-05-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
10 mei 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
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)
Beschrijving
STUDY CONCLUSION
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschrijving
study subject participation status
Datatype
text
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
Reason, no completion as planned
Datatype
integer
Alias
- UMLS CUI [1]
- C1709849
Beschrijving
Other reason
Datatype
text
Alias
- UMLS CUI [1]
- C3840932
Beschrijving
reason for withdrawal
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2349954
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2349954
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C1531784
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0013227
Beschrijving
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
Pregnancy during study
Datatype
text
Alias
- UMLS CUI [1]
- C0549206
Beschrijving
Pregnant Partner in relationship
Datatype
text
Alias
- UMLS CUI [1,1]
- C0549206
- UMLS CUI [1,2]
- C0682323
Beschrijving
Statement investigator
Alias
- UMLS CUI-1
- C1710187
- UMLS CUI-2
- C2826892
Beschrijving
Tick when done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1283174
Beschrijving
Tick when done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1283174
Beschrijving
Tick when done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0805732
- UMLS CUI [1,2]
- C1283174
Beschrijving
Tick when done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1283174
Beschrijving
I certify to the best of my knowledge, that the observations and findings are recorded correctly and completely in this CRF.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
day month year
Datatype
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])