ID

36219

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 Eligibility criteria for. It has to be filled in for screening.

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  1. 01-09-17 01-09-17 -
  2. 23-04-19 23-04-19 -
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GlaxoSmithKline

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23 april 2019

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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Engels

Eligibility criteria

1 Formulieren  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Beschrijving

Volunteer panel number

Datatype

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy, male and female subjects between 18 and 65 years of age inclusive.
Beschrijving

Gender, Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Body mass index of 19 to 29kg/m^2 , with a body weight of at least 50kg.
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
No abnormality on clinical examination.
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0559229
UMLS CUI [1,2]
C1456356
No abnormality revealed by the clinical laboratory parameters examination at the pre-study medical examination.
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0438215
A normal 12-lead ECG at the pre-study screening.
Beschrijving

12-lead ECG

Datatype

boolean

Alias
UMLS CUI [1]
C0430456
Normal systolic (100-140mmHg) and diastolic (<90mmHg) blood pressure (Supine) at pre-study screening and pre-dose Day 1.
Beschrijving

Normal blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0005823
Written informed consent prior to admission to the study.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Subjects who smoke more than 10 cigarettes per day.
Beschrijving

Number of cigarettes per day

Datatype

boolean

Alias
UMLS CUI [1]
C3694146
History or presence of clinically significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
Beschrijving

Comorbidity cardiovascular, neurological, psychiatric, haematological or renal

Datatype

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
History of postural hypotension or faints.
Beschrijving

Postural hypotension, faints

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020651
UMLS CUI [1,2]
C0039070
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Beschrijving

Comorbidity Interferes with drug metabolism

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0521102
The subject has received prescribed medication within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day (apart from medications that are described below), which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subjects’ safety.
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
Women on HRT treatments during which the proportions of oestrogen and progesterone are not kept constant throughout their 28-day cycle. e.g. some cyclic HRT treatments.
Beschrijving

Hormone therapy

Datatype

text

Alias
UMLS CUI [1]
C0279025
7. Withdrawal, introduction, or change in dose of any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing. Subjects who are on stable doses (no change within 7 days of 1 st dose) of any CYP1A2 medications are permitted to participate, if, in the opinion of the Principal investigator and in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety.
Beschrijving

drug dose

Datatype

boolean

Alias
UMLS CUI [1]
C0678766
Pregnancy and/or breast-feeding.
Beschrijving

Pregnancy; breast-feeding

Datatype

text

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Females of child-bearing potential who are not practicing a clinically accepted method of contraception such as surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant ® ).
Beschrijving

Females of child-bearing potential; method of contraception

Datatype

text

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Female subjects with positive urine/serum pregnancy test result at screening or prior to first dose.
Beschrijving

Pregnancy test positive

Datatype

text

Alias
UMLS CUI [1]
C0240802
Recent history (within the last 6 months), or suspicion, of drug dependence or a positive screening or pre-dose drugs of abuse screen.
Beschrijving

Substance use disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
Abuse of alcohol (defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women.
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1]
C0085762
Positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies.
Beschrijving

Hepatitis B surface antigen hepatitis C antibody positive; HIV Antibodies

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0281863
UMLS CUI [2]
C0019683
Participation in another clinical trial, blood donation or blood loss less than 90 days before the present study.
Beschrijving

Study subject participation status; blood donation

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0005794
Definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure.
Beschrijving

Hypersensitivity

Datatype

boolean

Alias
UMLS CUI [1]
C0020517
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Similar models

Eligibility criteria

1 Formulieren
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Volunteer panel number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender, Age
Item
Healthy, male and female subjects between 18 and 65 years of age inclusive.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body mass index
Item
Body mass index of 19 to 29kg/m^2 , with a body weight of at least 50kg.
boolean
C1305855 (UMLS CUI [1])
No abnormality on clinical examination
Item
No abnormality on clinical examination.
boolean
C0559229 (UMLS CUI [1,1])
C1456356 (UMLS CUI [1,2])
No abnormal laboratory parameters
Item
No abnormality revealed by the clinical laboratory parameters examination at the pre-study medical examination.
boolean
C1298908 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
12-lead ECG
Item
A normal 12-lead ECG at the pre-study screening.
boolean
C0430456 (UMLS CUI [1])
Normal blood pressure
Item
Normal systolic (100-140mmHg) and diastolic (<90mmHg) blood pressure (Supine) at pre-study screening and pre-dose Day 1.
boolean
C0005823 (UMLS CUI [1])
Informed consent
Item
Written informed consent prior to admission to the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Number of cigarettes per day
Item
Subjects who smoke more than 10 cigarettes per day.
boolean
C3694146 (UMLS CUI [1])
Comorbidity cardiovascular, neurological, psychiatric, haematological or renal
Item
History or presence of clinically significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
boolean
C0009488 (UMLS CUI [1,1])
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])
Postural hypotension, faints
Item
History of postural hypotension or faints.
boolean
C0020651 (UMLS CUI [1,1])
C0039070 (UMLS CUI [1,2])
Comorbidity Interferes with drug metabolism
Item
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
Medication
Item
The subject has received prescribed medication within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day (apart from medications that are described below), which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subjects’ safety.
boolean
C0013227 (UMLS CUI [1])
Item
Women on HRT treatments during which the proportions of oestrogen and progesterone are not kept constant throughout their 28-day cycle. e.g. some cyclic HRT treatments.
text
C0279025 (UMLS CUI [1])
hormone therapy
Code List
Women on HRT treatments during which the proportions of oestrogen and progesterone are not kept constant throughout their 28-day cycle. e.g. some cyclic HRT treatments.
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
drug dose
Item
7. Withdrawal, introduction, or change in dose of any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing. Subjects who are on stable doses (no change within 7 days of 1 st dose) of any CYP1A2 medications are permitted to participate, if, in the opinion of the Principal investigator and in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety.
boolean
C0678766 (UMLS CUI [1])
Item
Pregnancy and/or breast-feeding.
text
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hormone therapy
Code List
Pregnancy and/or breast-feeding.
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
Item
Females of child-bearing potential who are not practicing a clinically accepted method of contraception such as surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant ® ).
text
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
hormone therapy
Code List
Females of child-bearing potential who are not practicing a clinically accepted method of contraception such as surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant ® ).
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
Item
Female subjects with positive urine/serum pregnancy test result at screening or prior to first dose.
text
C0240802 (UMLS CUI [1])
hormone therapy
Code List
Female subjects with positive urine/serum pregnancy test result at screening or prior to first dose.
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
Substance use disorder
Item
Recent history (within the last 6 months), or suspicion, of drug dependence or a positive screening or pre-dose drugs of abuse screen.
boolean
C0038586 (UMLS CUI [1])
Alcohol abuse
Item
Abuse of alcohol (defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women.
boolean
C0085762 (UMLS CUI [1])
Hepatitis B surface antigen hepatitis C antibody positive; HIV Antibodies
Item
Positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies.
boolean
C0019168 (UMLS CUI [1,1])
C0281863 (UMLS CUI [1,2])
C0019683 (UMLS CUI [2])
Study subject participation status; blood donation
Item
Participation in another clinical trial, blood donation or blood loss less than 90 days before the present study.
boolean
C2348568 (UMLS CUI [1])
C0005794 (UMLS CUI [2])
Hypersensitivity
Item
Definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure.
boolean
C0020517 (UMLS CUI [1])
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