ID

44363

Beschrijving

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Trefwoorden

Versies (2)
  1. 06-03-19 06-03-19 -
  2. 20-09-21 20-09-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0
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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

Engels

Baseline

1 Formulieren  
  1. StudyEvent: ODM
    1. Baseline
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beschrijving

Study Coordinating Center, Identification number

Datatype

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschrijving

Person Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Inclusion/Exclusion Criteria
Beschrijving

Inclusion/Exclusion Criteria

Alias
UMLS CUI-1
C0013893
Inclusion - Patient has a total score ≥ 15 on the RLS Rating Scale at baseline.
Beschrijving

Restless Legs Syndrome, Score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0449820
Exclusion - Signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anemia, or pregnancy at baseline.
Beschrijving

Secondary Restless Legs Syndrome; Iron deficiency anemia; Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0035258
UMLS CUI [2]
C0162316
UMLS CUI [3]
C0032961
Exclusion - Patient suffers from augmentation and/or end of dose rebound at baseline.
Beschrijving

Augmentation procedure; Rebound effect

Datatype

boolean

Alias
UMLS CUI [1]
C1293122
UMLS CUI [2]
C0549262
Patient has a clinically significant abnormal lab, ECG or physical exam findings not resolved by time of baseline examinations.
Beschrijving

Laboratory Procedures, Abnormality; ECG abnormality; Physical Examination, Abnormality

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0522055
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C1704258
Exclusion - Patient is taking any medication known to induce drowsiness, affect RLS or sleep (the minimum discontinuation period is generally 5 half lives or 7 consecutive nights medication free, prior to baseline, whichever is the longer period).
Beschrijving

Pharmaceutical Preparations, Drowsiness, Relationships; Pharmaceutical Preparations, Restless Legs Syndrome, Relationships; Pharmaceutical Preparations, Sleep, Relationships

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013144
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0035258
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0037313
UMLS CUI [3,3]
C0439849
Exclusion - Patient has a diastolic blood pressure ≥ 110mmHg or ≤ 50mmHg OR systolic blood pressure ≥180mmHg or ≤ 90mmHg at baseline.
Beschrijving

Systolic Pressure; Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
Exclusion - Patient has participated in any clinical drug or device trial in the three months prior to the baseline visit.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion - Patient has had a withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through to the end of study.
Beschrijving

Hormon Replacement Therapy; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 CYP1A2 Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C3850050
UMLS CUI [3]
C3850068
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Pulse (after 5 minutes sitting)
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Sitting Blood Pressure (after 5 minutes sitting) - Systolic
Beschrijving

Systolic Pressure, Sitting position

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure (after 5 minutes sitting) - Distolic
Beschrijving

Diastolic blood pressure, Sitting position

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Concomitant Medication
Beschrijving

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Medical Procedures
Beschrijving

Medical Procedures

Alias
UMLS CUI-1
C0199171
Baseline Signs and Symptoms (or events, or diagnoses)
Beschrijving

Baseline Signs and Symptoms (or events, or diagnoses)

Alias
UMLS CUI-1
C0037088
Please mark this box if no baseline events occurred prior to randomisation into study.
Beschrijving

No signs/symptoms, Baseline

Datatype

boolean

Alias
UMLS CUI [1,1]
C3846032
UMLS CUI [1,2]
C1442488
Baseline Event (please print clearly)
Beschrijving

Event, Baseline, Signs and Symptoms

Datatype

text

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0037088
Onset Date and Time
Beschrijving

Event,Baseline, Date of onset, Time of onset

Datatype

datetime

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0574845
UMLS CUI [1,4]
C0449244
Outcome
Beschrijving

If patient died, STOP: go to SAE section and follow instructions given there

Datatype

text

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C1274040
Event Course
Beschrijving

Event, Baseline, Course

Datatype

text

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0750729
Event Course Intermittent - No. of episodes
Beschrijving

Event, Baseline, Number of Episodes

Datatype

integer

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C4086638
Intensity (maximum)
Beschrijving

Event, Baseline, Symptom intensity

Datatype

text

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0518690
Relationship to study procedures performed prior to randomisation
Beschrijving

Event, Baseline, Study Subject Participation Status, Relationships

Datatype

text

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0439849
Corrective Therapy
Beschrijving

If ‘Yes’, record details in Prior and Concomitant Medication section and/or Health Care Resource Utilisation section if appropriate.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0087111
Was patient withdrawn due to this specific event?
Beschrijving

Event, Baseline, Patient withdrawn from trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0422727
Baseline Employment Status
Beschrijving

Baseline Employment Status

Alias
UMLS CUI-1
C0242271
UMLS CUI-2
C1442488
Which one of the following categories best describes the patient at this time?
Beschrijving

Employment status, Baseline

Datatype

text

Alias
UMLS CUI [1,1]
C0242271
UMLS CUI [1,2]
C1442488
If Part-time employment - list approximate hours per week
Beschrijving

Part-time Employment, Hours worked per week

Datatype

integer

Alias
UMLS CUI [1,1]
C0682294
UMLS CUI [1,2]
C2584953
If Volunteer/Unpaid work - list approximate hours per week
Beschrijving

Volunteer work, Unpaid work, Hours worked per week

Datatype

integer

Alias
UMLS CUI [1,1]
C2367294
UMLS CUI [1,2]
C0557361
UMLS CUI [1,3]
C2584953
If Retired - Date of retirement
Beschrijving

Retirement, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0035345
UMLS CUI [1,2]
C0011008
Please mark the one box below which best describes the category of the patient's occupation: (International Standard Classification of Occupations, ISCO-88 COM)
Beschrijving

If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work answer question

Datatype

text

Alias
UMLS CUI [1]
C0421456
RAMOS Randomization and Dispensing
Beschrijving

RAMOS Randomization and Dispensing

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0947323
Randomisation number
Beschrijving

Randomization, Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Container number
Beschrijving

Experimental drug, Containers, Identifier

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
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Similar models

Baseline

1 Formulieren
  1. StudyEvent: ODM
    1. Baseline
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Inclusion/Exclusion Criteria
C0013893 (UMLS CUI-1)
Restless Legs Syndrome, Score
Item
Inclusion - Patient has a total score ≥ 15 on the RLS Rating Scale at baseline.
boolean
C0035258 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Secondary Restless Legs Syndrome; Iron deficiency anemia; Pregnancy
Item
Exclusion - Signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anemia, or pregnancy at baseline.
boolean
C0035258 (UMLS CUI [1])
C0162316 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
Augmentation procedure; Rebound effect
Item
Exclusion - Patient suffers from augmentation and/or end of dose rebound at baseline.
boolean
C1293122 (UMLS CUI [1])
C0549262 (UMLS CUI [2])
Laboratory Procedures, Abnormality; ECG abnormality; Physical Examination, Abnormality
Item
Patient has a clinically significant abnormal lab, ECG or physical exam findings not resolved by time of baseline examinations.
boolean
C0022885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2])
C0031809 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
Pharmaceutical Preparations, Drowsiness, Relationships; Pharmaceutical Preparations, Restless Legs Syndrome, Relationships; Pharmaceutical Preparations, Sleep, Relationships
Item
Exclusion - Patient is taking any medication known to induce drowsiness, affect RLS or sleep (the minimum discontinuation period is generally 5 half lives or 7 consecutive nights medication free, prior to baseline, whichever is the longer period).
boolean
C0013227 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0037313 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
Systolic Pressure; Diastolic blood pressure
Item
Exclusion - Patient has a diastolic blood pressure ≥ 110mmHg or ≤ 50mmHg OR systolic blood pressure ≥180mmHg or ≤ 90mmHg at baseline.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Study Subject Participation Status
Item
Exclusion - Patient has participated in any clinical drug or device trial in the three months prior to the baseline visit.
boolean
C2348568 (UMLS CUI [1])
Hormon Replacement Therapy; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 CYP1A2 Inhibitors
Item
Exclusion - Patient has had a withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through to the end of study.
boolean
C0282402 (UMLS CUI [1])
C3850050 (UMLS CUI [2])
C3850068 (UMLS CUI [3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Heart rate
Item
Pulse (after 5 minutes sitting)
integer
C0018810 (UMLS CUI [1])
Systolic Pressure, Sitting position
Item
Sitting Blood Pressure (after 5 minutes sitting) - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic blood pressure, Sitting position
Item
Sitting Blood Pressure (after 5 minutes sitting) - Distolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item Group
Medical Procedures
C0199171 (UMLS CUI-1)
Item Group
Baseline Signs and Symptoms (or events, or diagnoses)
C0037088 (UMLS CUI-1)
No signs/symptoms, Baseline
Item
Please mark this box if no baseline events occurred prior to randomisation into study.
boolean
C3846032 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Event, Baseline, Signs and Symptoms
Item
Baseline Event (please print clearly)
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Event,Baseline, Date of onset, Time of onset
Item
Onset Date and Time
datetime
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0449244 (UMLS CUI [1,4])
Item
Outcome
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Event,Baseline, Result
Code List
Outcome
CL Item
Resolved  (1)
CL Item
Ongoing  (2)
CL Item
Died (3)
Item
Event Course
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,3])
Event,Baseline, Result
Code List
Event Course
CL Item
Intermittent (1)
CL Item
Constant (2)
Event, Baseline, Number of Episodes
Item
Event Course Intermittent - No. of episodes
integer
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Item
Intensity (maximum)
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Event, Baseline, Symptom intensity
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to study procedures performed prior to randomisation
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
Event, Baseline, Symptom intensity
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Event, Baseline, Therapeutic procedure
Item
Corrective Therapy
boolean
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Event, Baseline, Patient withdrawn from trial
Item
Was patient withdrawn due to this specific event?
boolean
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0422727 (UMLS CUI [1,3])
Item Group
Baseline Employment Status
C0242271 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Item
Which one of the following categories best describes the patient at this time?
text
C0242271 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Employment status, Baseline
Code List
Which one of the following categories best describes the patient at this time?
CL Item
Full time employment (1)
CL Item
Part-time employment  (2)
CL Item
Volunteer/Unpaid work  (3)
CL Item
Unemployed due to RLS (4)
CL Item
Unemployed due to other (NON-RLS) disability (5)
CL Item
Unemployed for other reason (6)
CL Item
Retired (7)
CL Item
Homemaker (8)
Part-time Employment, Hours worked per week
Item
If Part-time employment - list approximate hours per week
integer
C0682294 (UMLS CUI [1,1])
C2584953 (UMLS CUI [1,2])
Volunteer work, Unpaid work, Hours worked per week
Item
If Volunteer/Unpaid work - list approximate hours per week
integer
C2367294 (UMLS CUI [1,1])
C0557361 (UMLS CUI [1,2])
C2584953 (UMLS CUI [1,3])
Retirement, Date in time
Item
If Retired - Date of retirement
date
C0035345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Please mark the one box below which best describes the category of the patient's occupation: (International Standard Classification of Occupations, ISCO-88 COM)
text
C0421456 (UMLS CUI [1])
Patient occupation
Code List
Please mark the one box below which best describes the category of the patient's occupation: (International Standard Classification of Occupations, ISCO-88 COM)
CL Item
Legislator, senior official or manager (e.g. specialist managers, directors and chief executives) 2=Professional (e.g. teaching, legal, science and health professionals) (1)
CL Item
Technician or associate professional (computer associates, nurses/midwives, ship & aircraft controllers, police inspectors, finance & sales) (3)
CL Item
Clerk (e.g. secretaries, cashiers and other office clerks) (4)
CL Item
Service worker or shop and market sales worker (e.g. housekeeping and restaurant services, shop salesperson & demonstrators, and models) (5)
CL Item
Skilled agricultural or fishery worker (e.g. animal/crop producers, market gardeners, fishery workers, hunters and trappers) (6)
CL Item
Craft and related trades worker (e.g. miners, builders, blacksmiths, potters, glass-makers, textile workers) (7)
CL Item
Plant and machine operator or assembler (e.g. metal processing plant operators, food and related products machine operators) (8)
CL Item
Military (9)
Item Group
RAMOS Randomization and Dispensing
C0034656 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
Randomization, Numbers
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Experimental drug, Containers, Identifier
Item
Container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
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