ID

24445

Descripción

Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen 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 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Screening

Palabras clave

1/8/17 1/8/17 -

Titular de derechos de autor

GlaxoSmithKline

Subido en

1 de agosto de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC-ND 3.0

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Screening GSK Ropinirole Restless Legs Syndrome 101468

model
Detalles

Screening GSK Ropinirole Restless Legs Syndrome 101468

1 formularios

StudyEvent: ODM
1. Screening GSK Ropinirole Restless Legs Syndrome 101468

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Patient Information

Item Group

Patient Information

C1955348 (UMLS CUI-1)

Patient Number

Item

Patient Number

text

C1830427 (UMLS CUI [1])

Centre Number

Item

Centre Number

text

C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])

Date of Report

Item

Date of Interview

date

C1302584 (UMLS CUI [1])

Restless Legs Syndrome Diagnostic Criteria

Item Group

Restless Legs Syndrome Diagnostic Criteria - The International RLS Study Group Criteria* defines RLS patients as having. Answer to all four diagnostic criteria must be yes for the patient to be diagnosed with RLS.

C0035258 (UMLS CUI-1)
C0679228 (UMLS CUI-2)

Limb movement

Item

1. a desire to move the limbs usually associated with paresthesias or dysesthesias

boolean

C0596840 (UMLS CUI [1])

Motor Restlessness

Item

2. motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)

boolean

C0700075 (UMLS CUI [1])

Symptoms at rest

Item

3. symptoms worse or exclusively present at rest with at least partial and temporal relief by activity

boolean

C1457887 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])

Worsening in night

Item

4. symptoms worse in the evening or night

boolean

C0332271 (UMLS CUI [1,1])
C0240526 (UMLS CUI [1,2])

Medical History and Physical Examination

Item Group

Medical History and Physical Examination

C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)

Comorbidity

Item

Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?

boolean

Diagnosis

Item

Diagnosis

text

C0011900 (UMLS CUI [1])

Date of First Diagnosis

Item

Year of first diagnosis

date

C2316983 (UMLS CUI [1])

Past Medical History

Item

Past

boolean

C0262926 (UMLS CUI [1])

Ongoing

Item

Ongoing

boolean

C0549178 (UMLS CUI [1])

Smoking History

Item Group

Smoking History

C1519384 (UMLS CUI-1)

Smoking Status

Item

Is the subject a smoker?

boolean

C1519386 (UMLS CUI [1])

Smoking Years

Item

Number of years the subject has been a smoker?

float

C1277691 (UMLS CUI [1])

Cigarettes per day

Item

Average number of cigarettes smoked per day?

float

C3694146 (UMLS CUI [1])

Tobacco product

Item

Please state what type of tobacoo product (e.g. pipe, cigar, chewing tobacco or cigarette)

text

C3166496 (UMLS CUI [1])

Pharmacotherapy

Item Group

RLS Pharmacotherapy History

C0013216 (UMLS CUI-1)

Pharmacotherapy for RLS

Item

Has the patient taken any pharmacotherapy medication for treatment of RLS?

boolean

C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])

Drug name

Item

Drug Name (Trade Name Preferred)

text

C0013227 (UMLS CUI [1])

Start Date

Item

Start Date (be as precise as possible)

date

C0808070 (UMLS CUI [1])

End Date

Item

End Date

date

C0806020 (UMLS CUI [1])

Ongoing

Item

or if Continuing mark box

boolean

Response to treatment

Item

Did the patient respond to the treatment? (mark one)

text

C0521982 (UMLS CUI [1])

Response to treatment

Code List

Did the patient respond to the treatment? (mark one)

CL Item

Yes (Yes)

CL Item

No (No)

CL Item

Unknown (Unknown)

Tolerability

Item

Did the patient tolerate the treatment? (mark one)

text

C3274448 (UMLS CUI [1])

Tolerability

Code List

Did the patient tolerate the treatment? (mark one)

CL Item

Yes (Yes)

CL Item

No (No)

CL Item

Unknown (Unknown)

Vital Signs

Item Group

Vital Signs

C0518766 (UMLS CUI-1)

Date of Measurement

Item

Date

date

C0011008 (UMLS CUI [1])

Time

Item

Time

time

Semi-supine Systolic Blood Pressure

Item

Semi-supine Blood Pressure: Systolic (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure curff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study.

float

C0522019 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])

Semi-supine Diastolic Blood Pressure

Item

Semi-supine Blood Pressure: Diastolic (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure curff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study.)

float

C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])

Semi-supine Heart Rate

Item

Semi-supine Heart Rate (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure curff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study.)

float

C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])

Erect Systolic Blood Pressure

Item

Erect Blood Pressure: Systolic (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure curff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study. Repeat the erect measurement IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.)

float

C0522014 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])

Erect Diastolic Blood Pressure

Item

Erect Blood Pressure: Diastolic (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study. Repeat the erect measurement IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.)

float

C0522014 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])

Erect Heart Rate

Item

Erect Heart Rate (Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measuremnts will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on the same arm throughout the study. - The same sutdy nurse/operator should conduct all the blood pressure measurements for each clinic visit. - Ideally, the same study nurse/operator should conduct ALL the blood pressure measurements for each patient throughout the study. Repeat the erect measurement IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.)

float

C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])

ECG

Item Group

12 Lead ECG - Please affix ECG trace to this page.

C1623258 (UMLS CUI-1)

Date of ECG

Item

Date

date

C2826640 (UMLS CUI [1])

Time of ECG

Item

Actual Time

time

C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])

Heart Rate

Item

Heart Rate

float

C0018810 (UMLS CUI [1])

PR Interval

Item

float

C0429087 (UMLS CUI [1])

QRS Interval

Item

QRS

float

C1880451 (UMLS CUI [1])

QTC Interval

Item

QTC

float

C0855331 (UMLS CUI [1])

ECG clinically significant

Item

ECG clinically significant?

boolean

C1623258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])

ECG Comment

Item

Comments*

text

C0947611 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])

Clinical Chemistry & Haematology

Item Group

Laboratory Collections - Clinical Chemistry & Haematology: Ensure a blood sample has been taken for clinical chemistry and haematology

C0008000 (UMLS CUI-1)
C0474523 (UMLS CUI-3)

Date of Collection

Item

Exact date of blood sampling

date

C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Time of Collection

Item

Exact time of blood sampling

time

Comment

Item

Comments:

text

C0947611 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2,1])
C0474523 (UMLS CUI [2,2])

Clinical Chemistry & Haematology: Abnormal Findings

Item

Are there clinically significant abnormal values?

boolean

C1704258 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0474523 (UMLS CUI [2,2])

Drug Screening

Item Group

Drug Screening (Urine)

C0202274 (UMLS CUI-1)

Date of Drug Screening

Item

Exact date of sampling

date

C0011008 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])

Time of Drug Screeing

Item

Exact time of sampling

time

C0040223 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])

Contraindicated Drug

Item

Were there any contra-indicated drugs detected?

boolean

C1444657 (UMLS CUI [1,1])
C4036061 (UMLS CUI [1,2])

Type of Drug

Item

Type of Drug

text

C0457591 (UMLS CUI [1])

Drug Screening Comment

Item

Comment

text

C0202274 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

Urinanalysis

Item Group

Urinanalyis Test Results -Ensure a urine sample has been taken for urine dipstick

C0042014 (UMLS CUI-1)

Date of Urinanalysis

Item

Exact date of urine sampling

date

C0042014 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Time of Urinanalysis

Item

Exact time of urine sampling

time

C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

Urinanalysis abnormality

Item

Are there clinically significant abnormal values?

boolean

C0042014 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Urine pH

Item

Results for dip stick test: pH

text

C0042044 (UMLS CUI [1])

Urine pH: Clinically Significant

Item

Urine pH: Clinically Significant

boolean

C0042044 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])

Urine pH: Comment

Item

Urine pH: Comments

text

C0947611 (UMLS CUI [1,1])
C0042044 (UMLS CUI [1,2])

Urine Protein

Item

Results for dip stick test: Protein

text

C0262923 (UMLS CUI [1])

Urine Protein: Clinically Significant

Item

Urine Protein: Clinically Significant

boolean

C2826633 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])

Urine Glucose

Item

Results for dip stick test: Urine Glucose

text

C0004076 (UMLS CUI [1])

Urine Glucose: Clinically Significant

Item

Urine Glucose: Clinically Significant

boolean

C0004076 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])

Urine Glucose: Comment

Item

Urine Glucose: Comments

text

C0004076 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

Urine Bilirubin

Item

Results for dip stick test: Urine Bilirubin

text

C0042040 (UMLS CUI [1])

Urine Bilirubin: Clinically Significant

Item

Urine Bilirubin: Clinically Significant

boolean

C0042040 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])

Urine Bilirubin: Comments

Item

Urine Bilirubin: Comments

text

C0042040 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

Hematuria

Item

Results for dip stick test: Urine Blood

text

C0018965 (UMLS CUI [1])

Hematuria: Clinically Significant

Item

Urine Blood: Clinically Significant

boolean

C0018965 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])

Hematuria: Comments

Item

Blood Urine: Comments

text

C0018965 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

Pregnancy Test

Item Group

Pregnancy Test (Females only)

C0032976 (UMLS CUI-1)

Pregnancy Test

Item

Was a pregancy test carried out?

boolean

C0032976 (UMLS CUI [1])

Reason

Item

If 'NO', please specify reason:

text

C0392360 (UMLS CUI [1])

Date of Pregnany Test

Item

If 'YES', please indicate date of result:

date

C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])

Pregnancy Test Finding

Item

If 'YES', please indicate the result:

text

C0427777 (UMLS CUI [1])

Pregnancy Test Finding

Code List

If 'YES', please indicate the result:

CL Item

Positive (Positive)

CL Item

Negative (Negative)

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Titular de derechos de autor

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Screening GSK Ropinirole Restless Legs Syndrome 101468

Screening GSK Ropinirole Restless Legs Syndrome 101468

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