ID
36219
Beskrivning
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 Eligibility criteria for. It has to be filled in for screening.
Nyckelord
Versioner (2)
- 2017-09-01 2017-09-01 -
- 2019-04-23 2019-04-23 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 april 2019
DOI
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Licens
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
Eligibility criteria
- StudyEvent: ODM
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
Gender, Age
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
Beskrivning
Body mass index
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1305855
Beskrivning
A subject with a clinical abnormality may be included only if the Principal Investigator, in agreement with the Sponsor, considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0559229
- UMLS CUI [1,2]
- C1456356
Beskrivning
Subjects with laboratory values outside the reference range for this age group will only be included if the Principal Investigator considers that such findings will not introduce additional risk factors.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0438215
Beskrivning
12-lead ECG
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0430456
Beskrivning
Normal blood pressure
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Informed consent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Number of cigarettes per day
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3694146
Beskrivning
Comorbidity cardiovascular, neurological, psychiatric, haematological or renal
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C3887460
- UMLS CUI [2,1]
- C0009488
- UMLS CUI [2,2]
- C0746866
- UMLS CUI [3,1]
- C0009488
- UMLS CUI [3,2]
- C0846574
- UMLS CUI [4,1]
- C0009488
- UMLS CUI [4,2]
- C0279810
- UMLS CUI [5,1]
- C0009488
- UMLS CUI [5,2]
- C0232804
Beskrivning
Postural hypotension, faints
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0020651
- UMLS CUI [1,2]
- C0039070
Beskrivning
Comorbidity Interferes with drug metabolism
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0521102
Beskrivning
Subjects who have taken OTC medication (apart from CYP1A2 medications, see below) may still be entered into the study, if, in the opinion of the Principal/Co-investigator in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Hormone therapy
Datatyp
text
Alias
- UMLS CUI [1]
- C0279025
Beskrivning
drug dose
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0678766
Beskrivning
Pregnancy; breast-feeding
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Beskrivning
Females of child-bearing potential; method of contraception
Datatyp
text
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
Beskrivning
Pregnancy test positive
Datatyp
text
Alias
- UMLS CUI [1]
- C0240802
Beskrivning
Substance use disorder
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beskrivning
One unit is equivalent to half a pint of beer, one measure of spirits or one glass of wine) or a positive screening or pre-dose alcohol test.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085762
Beskrivning
Hepatitis B surface antigen hepatitis C antibody positive; HIV Antibodies
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0281863
- UMLS CUI [2]
- C0019683
Beskrivning
Study subject participation status; blood donation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0005794
Beskrivning
Hypersensitivity
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0020517
Similar models
Eligibility criteria
- StudyEvent: ODM
C0001779 (UMLS CUI [2])
C1456356 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,2])
C3887460 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0746866 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0846574 (UMLS CUI [3,2])
C0009488 (UMLS CUI [4,1])
C0279810 (UMLS CUI [4,2])
C0009488 (UMLS CUI [5,1])
C0232804 (UMLS CUI [5,2])
C0039070 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
C0281863 (UMLS CUI [1,2])
C0019683 (UMLS CUI [2])
C0005794 (UMLS CUI [2])