ID
36219
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 Eligibility criteria for. It has to be filled in for screening.
Stichworte
Versionen (2)
- 01.09.17 01.09.17 -
- 23.04.19 23.04.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
23. April 2019
DOI
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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
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Gender, Age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
Beschreibung
Body mass index
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0559229
- UMLS CUI [1,2]
- C1456356
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0438215
Beschreibung
12-lead ECG
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0430456
Beschreibung
Normal blood pressure
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Number of cigarettes per day
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3694146
Beschreibung
Comorbidity cardiovascular, neurological, psychiatric, haematological or renal
Datentyp
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
Beschreibung
Postural hypotension, faints
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020651
- UMLS CUI [1,2]
- C0039070
Beschreibung
Comorbidity Interferes with drug metabolism
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C0521102
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Hormone therapy
Datentyp
text
Alias
- UMLS CUI [1]
- C0279025
Beschreibung
drug dose
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0678766
Beschreibung
Pregnancy; breast-feeding
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Beschreibung
Females of child-bearing potential; method of contraception
Datentyp
text
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
Beschreibung
Pregnancy test positive
Datentyp
text
Alias
- UMLS CUI [1]
- C0240802
Beschreibung
Substance use disorder
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085762
Beschreibung
Hepatitis B surface antigen hepatitis C antibody positive; HIV Antibodies
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0281863
- UMLS CUI [2]
- C0019683
Beschreibung
Study subject participation status; blood donation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0005794
Beschreibung
Hypersensitivity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0020517
Ähnliche Modelle
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])