ID
36396
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 study conclusion form. In this Pregnancy information is included. The document has to be filled in for the end of study.
Mots-clés
Versions (3)
- 05/09/2017 05/09/2017 -
- 10/05/2019 10/05/2019 -
- 10/05/2019 10/05/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
10 mai 2019
DOI
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Licence
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
- StudyEvent: ODM
Description
STUDY CONCLUSION
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
study subject participation status
Type de données
text
Alias
- UMLS CUI [1]
- C2348568
Description
Reason, no completion as planned
Type de données
integer
Alias
- UMLS CUI [1]
- C1709849
Description
Other reason
Type de données
text
Alias
- UMLS CUI [1]
- C3840932
Description
reason for withdrawal
Type de données
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008976
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2349954
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2349954
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C1531784
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0013227
Description
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
Pregnancy during study
Type de données
text
Alias
- UMLS CUI [1]
- C0549206
Description
Pregnant Partner in relationship
Type de données
text
Alias
- UMLS CUI [1,1]
- C0549206
- UMLS CUI [1,2]
- C0682323
Similar models
Study Conclusion, Pregnancy information
- StudyEvent: ODM
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])