ID
36219
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 Eligibility criteria for. It has to be filled in for screening.
Keywords
Versions (2)
- 9/1/17 9/1/17 -
- 4/23/19 4/23/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 23, 2019
DOI
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License
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
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Gender, Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
Description
Body mass index
Data type
boolean
Alias
- UMLS CUI [1]
- C1305855
Description
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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0559229
- UMLS CUI [1,2]
- C1456356
Description
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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0438215
Description
12-lead ECG
Data type
boolean
Alias
- UMLS CUI [1]
- C0430456
Description
Normal blood pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0005823
Description
Informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Number of cigarettes per day
Data type
boolean
Alias
- UMLS CUI [1]
- C3694146
Description
Comorbidity cardiovascular, neurological, psychiatric, haematological or renal
Data type
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
Description
Postural hypotension, faints
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020651
- UMLS CUI [1,2]
- C0039070
Description
Comorbidity Interferes with drug metabolism
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0521102
Description
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.
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
Description
Hormone therapy
Data type
text
Alias
- UMLS CUI [1]
- C0279025
Description
drug dose
Data type
boolean
Alias
- UMLS CUI [1]
- C0678766
Description
Pregnancy; breast-feeding
Data type
text
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Description
Females of child-bearing potential; method of contraception
Data type
text
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
Description
Pregnancy test positive
Data type
text
Alias
- UMLS CUI [1]
- C0240802
Description
Substance use disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
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.
Data type
boolean
Alias
- UMLS CUI [1]
- C0085762
Description
Hepatitis B surface antigen hepatitis C antibody positive; HIV Antibodies
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0281863
- UMLS CUI [2]
- C0019683
Description
Study subject participation status; blood donation
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0005794
Description
Hypersensitivity
Data type
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])