ID

39417

Description

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Keywords

Versions (4)
  1. 12/2/19 12/2/19 -
  2. 12/5/19 12/5/19 -
  3. 12/6/19 12/6/19 -
  4. 1/9/20 1/9/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 2020

DOI

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License

Creative Commons BY-NC 3.0
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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532)

English

Eligibility - Screening; Baseline

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Description

Study Name

Data type

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Eligibility
Description

Eligibility

Alias
UMLS CUI-1
C0013893
Protocol Amendment
Description

Protocol Amendment

Data type

integer

Alias
UMLS CUI [1]
C4321383
Did the subject meet all the entry criteria?
Description

Did the subject meet all the entry criteria?

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Diagnosis of idiopathic Parkinson's disease (according to modified Hoehn & Yard criteria Stages I - IV) and demonstrating lack of control with L-dopa therapy (e.g. end of dose akinesia, simple on/off fluctuations)
Description

Diagnosis of idiopathic Parkinson's disease and demonstrating lack of control with L-dopa therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0332240
UMLS CUI [2]
C3639878
UMLS CUI [3,1]
C0023570
UMLS CUI [3,2]
C0243148
UMLS CUI [3,3]
C0332268
UMLS CUI [4]
C0085623
UMLS CUI [5,1]
C0231239
UMLS CUI [5,2]
C0852903
Receiving a stable dose of L-dopa for at least 4 weeks prior to screening
Description

Receiving a stable dose of L-dopa for at least 4 weeks prior to screening

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0220908
UMLS CUI [2,2]
C0332152
If female of child-bearing potential, practicing a clinically accepted method of contraception during the study and for at least one month prior to randomization and one month following completion of study.
Description

Gender; Childbearing Potential | Contraceptive methods; Acceptance status | During; Clinical Trials | Randomization; Before | Study Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C3176353
UMLS CUI [3,1]
C0347984
UMLS CUI [3,2]
C0008976
UMLS CUI [4,1]
C0034656
UMLS CUI [4,2]
C0332152
UMLS CUI [5]
C2348557
30 years of age or greater at screening
Description

30 years of age or greater at screening

Data type

boolean

Alias
UMLS CUI [1]
C0001779
A minimum of 3 hours awake "off-time" for each diary day recorded during the baseline period
Description

A minimum of 3 hours awake "off-time" for each diary day recorded during the baseline period

Data type

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0439228
UMLS CUI [3,1]
C1442488
UMLS CUI [3,2]
C0347984
Willing and able to comply with study procedures, including diary card completion and follow-up clinic visits
Description

Willing and able to comply with study procedures, including diary card completion and follow-up clinic visits

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0805732
UMLS CUI [3,1]
C1522577
UMLS CUI [3,2]
C0008952
Provided written informed consent for this study
Description

Provided written informed consent for this study

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Is subject either affiliated to or a beneficiary of a social security category?
Description

Is subject either affiliated to or a beneficiary of a social security category?

Data type

boolean

Alias
UMLS CUI [1,1]
C0037435
UMLS CUI [1,2]
C1510826
UMLS CUI [1,3]
C1550502
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Late stage advanced subject demonstrating incapacitating peak dose or diphasic dyskinesia on their stable dose of L-dopa
Description

Late stage advanced subject demonstrating incapacitating peak dose or diphasic dyskinesia on their stable dose of L-dopa

Data type

boolean

Alias
UMLS CUI [1]
C0544467
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C0444505
UMLS CUI [3]
C0013384
UMLS CUI [4,1]
C0023570
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
Consumption of any dopamine agonist, including ropinirole, within four weeks of randomization in the study
Description

Consumption of any dopamine agonist, including ropinirole, within four weeks of randomization in the study

Data type

boolean

Alias
UMLS CUI [1]
C0178601
UMLS CUI [2]
C0244821
UMLS CUI [3]
C0034656
Severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the Investigator, would render the subject unsuitable for the study (e.g. psychiatric, haematological, renal, hepatic, endocrinology, neurological other than Parkinson's disease, cardiovascular, or active malignancy other than basal cell carcinoma)
Description

Severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the Investigator, would render the subject unsuitable for the study

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2826293
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C2348568
UMLS CUI [4]
C0004936
UMLS CUI [5,1]
C0279810
UMLS CUI [5,2]
C0012634
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0007222
UMLS CUI [11]
C0006826
UMLS CUI [12,1]
C0007117
UMLS CUI [12,2]
C0205394
Crippling degenerative arthritis or other physical or mental condition(s) which would preclude accurate assessment of efficacy or safety
Description

Crippling degenerative arthritis or other physical or mental condition(s) which would preclude accurate assessment of efficacy or safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0029408
UMLS CUI [1,3]
C0010331
UMLS CUI [2,1]
C3714565
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0205394
UMLS CUI [4,1]
C1280519
UMLS CUI [4,2]
C0220825
UMLS CUI [4,3]
C0332196
UMLS CUI [5,1]
C0549076
UMLS CUI [5,2]
C0332196
Prior or current major psychosis (e.g. schizophrenia or psychotic depression) scoring e.g. 3 or 4 on UPDRS item II (thought disorder) or item III (depression)
Description

Prior or current major psychosis (e.g. schizophrenia or psychotic depression) scoring e.g. 3 or 4 on UPDRS item II (thought disorder) or item III (depression)

Data type

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0743072
UMLS CUI [4]
C3639837
UMLS CUI [5,1]
C3639721
UMLS CUI [5,2]
C0011581
Severe clinical dementia scoring e.g. 3 or 4 on UPDRS item I (mentation)
Description

Severe clinical dementia scoring e.g. 3 or 4 on UPDRS item I (mentation)

Data type

boolean

Alias
UMLS CUI [1,1]
C3639721
UMLS CUI [1,2]
C3494652
Severe dizziness or fainting due to postural hypotension on standing
Description

Severe dizziness or fainting due to postural hypotension on standing

Data type

boolean

Alias
UMLS CUI [1,1]
C0012833
UMLS CUI [1,2]
C0020651
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0039070
UMLS CUI [2,2]
C0020651
UMLS CUI [2,3]
C0205082
Personal history of melanoma
Description

Personal history of melanoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0025202
UMLS CUI [1,2]
C0262926
Clinically significant abnormalities in laboratory or ECG tests at screening. If findings are outside the normal range and the subject is included, it must be documented by the investigator that the findings are not of clinical significance
Description

Clinically significant abnormalities in laboratory or ECG tests at screening.

Data type

boolean

Alias
UMLS CUI [1,1]
C1853129
UMLS CUI [1,2]
C0220908
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C0220908
UMLS CUI [3]
C0086715
UMLS CUI [4]
C2826293
Diagnosed with an impulse control disorder. The modified MIDI will be conducted at screening. Subjects who score positive for this screen must be referred to a specialist for a diagnostic evaluation
Description

Diagnosed with an impulse control disorder.

Data type

boolean

Alias
UMLS CUI [1]
C0021122
UMLS CUI [2]
C0220908
UMLS CUI [3,1]
C0430022
UMLS CUI [3,2]
C0220825
Active suicidal plan/intent or have had active suicidal thoughts in the past 6 months. Subjects who have a history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt
Description

Planning suicide | Feeling suicidal (finding) | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1]
C0424001
UMLS CUI [2]
C0424000
UMLS CUI [3]
C0038663
Current alcohol or drug dependence
Description

Current alcohol or drug dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0085762
Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long-term dosing with ropinirole
Description

Adverse reactions; Clinical Significance; ropinirole | Hypersensitivity; Clinical Significance; ropinirole | Chemical Structure; Similarity | Long-term drug therapy; ropinirole

Data type

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0244821
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0244821
UMLS CUI [3,1]
C0220807
UMLS CUI [3,2]
C2348205
UMLS CUI [4,1]
C0420257
UMLS CUI [4,2]
C0244821
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYPIA2 (e.g. Ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYPIA2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment (randomization). Any subject already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrollment (randomization) through the end of the treatment period
Description

Withdraw (activity); Medication dose | Introduction procedure; Medication dose | Dose Modification; Hormone replacement therapy | Drug inhibition of cytochrome p450 CYP1A2 enzyme | Ciprofloxacin | Fluvoxamine | Cimetidine | Ethinyl Estradiol | Tobacco | Omeprazole | Randomization; Before | Therapeutic procedure; chronic | Medication regimen; Stable status

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C3174092
UMLS CUI [2,1]
C1293116
UMLS CUI [2,2]
C3174092
UMLS CUI [3,1]
C1707811
UMLS CUI [3,2]
C0282402
UMLS CUI [4]
C1827504
UMLS CUI [5]
C0008809
UMLS CUI [6]
C0085228
UMLS CUI [7]
C0008783
UMLS CUI [8]
C0015011
UMLS CUI [9,1]
C3898767
UMLS CUI [9,2]
C1620185
UMLS CUI [10]
C0040329
UMLS CUI [11]
C0028978
UMLS CUI [12,1]
C0034656
UMLS CUI [12,2]
C0332152
UMLS CUI [13,1]
C0087111
UMLS CUI [13,2]
C0205191
UMLS CUI [14]
C0237125
Female currently pregnant or breast-feeding
Description

Female currently pregnant or breast-feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Use of an Investigational drug from 30 days or 5 half-lives (which ever is longer) prior to baseline (randomization) through to the end of the treatment period
Description

Use of an Investigational drug from 30 days or 5 half-lives (which ever is longer) prior to baseline (randomization) through to the end of the treatment period

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C1442488
UMLS CUI [2,2]
C0332152
UMLS CUI [3]
C0034656
UMLS CUI [4]
C1531784
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Similar models

Eligibility - Screening; Baseline

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Name
Item
Study Name
text
C2348560 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Study Site
Item
Study Site
text
C2825164 (UMLS CUI [1])
Item Group
Eligibility
C0013893 (UMLS CUI-1)
Item
Protocol Amendment
integer
C4321383 (UMLS CUI [1])
Protocol Amendment
Code List
Protocol Amendment
CL Item
0 (0)
CL Item
1 (1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Diagnosis of idiopathic Parkinson's disease and demonstrating lack of control with L-dopa therapy
Item
Diagnosis of idiopathic Parkinson's disease (according to modified Hoehn & Yard criteria Stages I - IV) and demonstrating lack of control with L-dopa therapy (e.g. end of dose akinesia, simple on/off fluctuations)
boolean
C0030567 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C3639878 (UMLS CUI [2])
C0023570 (UMLS CUI [3,1])
C0243148 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C0085623 (UMLS CUI [4])
C0231239 (UMLS CUI [5,1])
C0852903 (UMLS CUI [5,2])
Receiving a stable dose of L-dopa for at least 4 weeks prior to screening
Item
Receiving a stable dose of L-dopa for at least 4 weeks prior to screening
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0220908 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Gender; Childbearing Potential | Contraceptive methods; Acceptance status | During; Clinical Trials | Randomization; Before | Study Completed
Item
If female of child-bearing potential, practicing a clinically accepted method of contraception during the study and for at least one month prior to randomization and one month following completion of study.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C3176353 (UMLS CUI [2,2])
C0347984 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0034656 (UMLS CUI [4,1])
C0332152 (UMLS CUI [4,2])
C2348557 (UMLS CUI [5])
30 years of age or greater at screening
Item
30 years of age or greater at screening
boolean
C0001779 (UMLS CUI [1])
A minimum of 3 hours awake "off-time" for each diary day recorded during the baseline period
Item
A minimum of 3 hours awake "off-time" for each diary day recorded during the baseline period
boolean
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
C3890583 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
C1442488 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
Willing and able to comply with study procedures, including diary card completion and follow-up clinic visits
Item
Willing and able to comply with study procedures, including diary card completion and follow-up clinic visits
boolean
C0525058 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0805732 (UMLS CUI [2,2])
C1522577 (UMLS CUI [3,1])
C0008952 (UMLS CUI [3,2])
Provided written informed consent for this study
Item
Provided written informed consent for this study
boolean
C0021430 (UMLS CUI [1])
Is subject either affiliated to or a beneficiary of a social security category?
Item
Is subject either affiliated to or a beneficiary of a social security category?
boolean
C0037435 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C1550502 (UMLS CUI [1,3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Late stage advanced subject demonstrating incapacitating peak dose or diphasic dyskinesia on their stable dose of L-dopa
Item
Late stage advanced subject demonstrating incapacitating peak dose or diphasic dyskinesia on their stable dose of L-dopa
boolean
C0544467 (UMLS CUI [1])
C3174092 (UMLS CUI [2,1])
C0444505 (UMLS CUI [2,2])
C0013384 (UMLS CUI [3])
C0023570 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Consumption of any dopamine agonist, including ropinirole, within four weeks of randomization in the study
Item
Consumption of any dopamine agonist, including ropinirole, within four weeks of randomization in the study
boolean
C0178601 (UMLS CUI [1])
C0244821 (UMLS CUI [2])
C0034656 (UMLS CUI [3])
Severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the Investigator, would render the subject unsuitable for the study
Item
Severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the Investigator, would render the subject unsuitable for the study (e.g. psychiatric, haematological, renal, hepatic, endocrinology, neurological other than Parkinson's disease, cardiovascular, or active malignancy other than basal cell carcinoma)
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0030567 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0279810 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0007222 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
C0007117 (UMLS CUI [12,1])
C0205394 (UMLS CUI [12,2])
Crippling degenerative arthritis or other physical or mental condition(s) which would preclude accurate assessment of efficacy or safety
Item
Crippling degenerative arthritis or other physical or mental condition(s) which would preclude accurate assessment of efficacy or safety
boolean
C0003864 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0010331 (UMLS CUI [1,3])
C3714565 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C3840291 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C1280519 (UMLS CUI [4,1])
C0220825 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0549076 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
Prior or current major psychosis (e.g. schizophrenia or psychotic depression) scoring e.g. 3 or 4 on UPDRS item II (thought disorder) or item III (depression)
Item
Prior or current major psychosis (e.g. schizophrenia or psychotic depression) scoring e.g. 3 or 4 on UPDRS item II (thought disorder) or item III (depression)
boolean
C0033975 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
C0743072 (UMLS CUI [3])
C3639837 (UMLS CUI [4])
C3639721 (UMLS CUI [5,1])
C0011581 (UMLS CUI [5,2])
Severe clinical dementia scoring e.g. 3 or 4 on UPDRS item I (mentation)
Item
Severe clinical dementia scoring e.g. 3 or 4 on UPDRS item I (mentation)
boolean
C3639721 (UMLS CUI [1,1])
C3494652 (UMLS CUI [1,2])
Severe dizziness or fainting due to postural hypotension on standing
Item
Severe dizziness or fainting due to postural hypotension on standing
boolean
C0012833 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0039070 (UMLS CUI [2,1])
C0020651 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Personal history of melanoma
Item
Personal history of melanoma
boolean
C0025202 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Clinically significant abnormalities in laboratory or ECG tests at screening.
Item
Clinically significant abnormalities in laboratory or ECG tests at screening. If findings are outside the normal range and the subject is included, it must be documented by the investigator that the findings are not of clinical significance
boolean
C1853129 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C0086715 (UMLS CUI [3])
C2826293 (UMLS CUI [4])
Diagnosed with an impulse control disorder.
Item
Diagnosed with an impulse control disorder. The modified MIDI will be conducted at screening. Subjects who score positive for this screen must be referred to a specialist for a diagnostic evaluation
boolean
C0021122 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
C0430022 (UMLS CUI [3,1])
C0220825 (UMLS CUI [3,2])
Planning suicide | Feeling suicidal (finding) | Suicide attempt
Item
Active suicidal plan/intent or have had active suicidal thoughts in the past 6 months. Subjects who have a history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt
boolean
C0424001 (UMLS CUI [1])
C0424000 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
Current alcohol or drug dependence
Item
Current alcohol or drug dependence
boolean
C0038580 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Adverse reactions; Clinical Significance; ropinirole | Hypersensitivity; Clinical Significance; ropinirole | Chemical Structure; Similarity | Long-term drug therapy; ropinirole
Item
Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long-term dosing with ropinirole
boolean
C0559546 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0244821 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0244821 (UMLS CUI [2,3])
C0220807 (UMLS CUI [3,1])
C2348205 (UMLS CUI [3,2])
C0420257 (UMLS CUI [4,1])
C0244821 (UMLS CUI [4,2])
Withdraw (activity); Medication dose | Introduction procedure; Medication dose | Dose Modification; Hormone replacement therapy | Drug inhibition of cytochrome p450 CYP1A2 enzyme | Ciprofloxacin | Fluvoxamine | Cimetidine | Ethinyl Estradiol | Tobacco | Omeprazole | Randomization; Before | Therapeutic procedure; chronic | Medication regimen; Stable status
Item
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYPIA2 (e.g. Ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYPIA2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment (randomization). Any subject already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrollment (randomization) through the end of the treatment period
boolean
C2349954 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C1293116 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C1707811 (UMLS CUI [3,1])
C0282402 (UMLS CUI [3,2])
C1827504 (UMLS CUI [4])
C0008809 (UMLS CUI [5])
C0085228 (UMLS CUI [6])
C0008783 (UMLS CUI [7])
C0015011 (UMLS CUI [8])
C3898767 (UMLS CUI [9,1])
C1620185 (UMLS CUI [9,2])
C0040329 (UMLS CUI [10])
C0028978 (UMLS CUI [11])
C0034656 (UMLS CUI [12,1])
C0332152 (UMLS CUI [12,2])
C0087111 (UMLS CUI [13,1])
C0205191 (UMLS CUI [13,2])
C0237125 (UMLS CUI [14])
Female currently pregnant or breast-feeding
Item
Female currently pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Use of an Investigational drug from 30 days or 5 half-lives (which ever is longer) prior to baseline (randomization) through to the end of the treatment period
Item
Use of an Investigational drug from 30 days or 5 half-lives (which ever is longer) prior to baseline (randomization) through to the end of the treatment period
boolean
C0013230 (UMLS CUI [1])
C1442488 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0034656 (UMLS CUI [3])
C1531784 (UMLS CUI [4])
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