ID

44355

Description

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

Mots-clés

Trial screening

D016430

Restless-legs-Syndrom

05/03/2019 05/03/2019 -
20/09/2021 20/09/2021 -

Détendeur de droits

GlaxoSmithKline

Téléchargé le

20 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

model
Détails

Screening

1 Formulaires

StudyEvent: ODM
1. Screening

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Administrative documentation

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])

Restless Legs Syndrome, Screening procedure, Medical History

Item Group

RLS Screen History

C0035258 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
C0262926 (UMLS CUI-3)

Restless Legs Syndrome, Age of Onset

Item

How old was the patient at the onset of RLS?

integer

C0035258 (UMLS CUI [1,1])
C0206132 (UMLS CUI [1,2])

Restless Legs Syndrome, Pharmaceutical Preparations, Relationships

Item

Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?

boolean

C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])

Restless Legs Syndrome, Pharmaceutical Preparations, Relationships

Item

If ’Yes’ please specify medication(s)

text

C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])

Restless Legs Syndrome, During, Pregnancy

Item

If female, did RLS symptoms develop during pregnancy?

text

C0035258 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])

Restless Legs Syndrome, During, Pregnancy

Code List

If female, did RLS symptoms develop during pregnancy?

CL Item

No (1)

CL Item

Yes (2)

CL Item

Not applicable (3)

Limb movement, Sleep

Item

Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?

boolean

C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])

Limb movement, Sleep, Age of Onset

Item

How old was the patient at the onset of PLMS?

integer

C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0206132 (UMLS CUI [1,3])

Alcohol consumption

Item

Does the patient drink alcohol?

boolean

C0001948 (UMLS CUI [1])

Alcohol consumption, alcohol units/week

Item

Units/week

integer

C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])

Caffeine consumption

Item

Does the patient drink caffeine (coffee, tea, caffeinated drinks)?

boolean

C0948365 (UMLS CUI [1])

Caffeine consumption, cups of coffee consumed per day (___cups/day)

Item

Cups/day

integer

C0948365 (UMLS CUI [1,1])
C2164136 (UMLS CUI [1,2])

Sleep Disorders

Item

Does the patient have any sleep disorder as defined by DSM IV?

boolean

C0851578 (UMLS CUI [1])

Restless Legs Syndrome, Family History

Item

Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?

text

C0035258 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])

Restless Legs Syndrome, Family History

Code List

Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?

CL Item

No (1)

CL Item

Yes (2)

CL Item

Unknown (3)

Limb movement, Sleep, Family History

Item

Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of PLMS?

text

C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])

Restless Legs Syndrome, Family History

Code List

Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of PLMS?

CL Item

No (1)

CL Item

Yes (2)

CL Item

Unknown (3)

Restless Legs Syndrome; Symptoms; Temporal periods of day

Item

Are the patient’s current symptoms mainly present ...

text

C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])

Restless Legs Syndrome; Symptoms; Temporal periods of day

Code List

Are the patient’s current symptoms mainly present ...

CL Item

At nightime only (1)

CL Item

In evening and nightime (2)

CL Item

Daytime, evening and nightime (3)

Restless Legs Syndrome, Diagnostic criteria

Item Group

RLS Diagnostic Criteria

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

Restless Legs Syndrome, limb movement, desire; Restless Legs Syndrome, Paresthesia; Restless Legs Syndrome, Dysesthesia

Item

The International RLS Study Group Criteria* defines RLS patients as having a desire to move the limbs usually associated with paresthesias or dysesthesias.

boolean

C0035258 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0871633 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C0030554 (UMLS CUI [2,2])
C0035258 (UMLS CUI [3,1])
C0392699 (UMLS CUI [3,2])

Restless Legs Syndrome, Motor Restlessness

Item

The International RLS Study Group Criteria* defines RLS patients as having motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort).

boolean

C0035258 (UMLS CUI [1,1])
C0700075 (UMLS CUI [1,2])

Restless Legs Syndrome, Symptoms, Rest; Restless Legs Syndrom, Physical activity, Feeling relief

Item

The International RLS Study Group Criteria* defines RLS patients as having symptoms worse or exclusively present at rest with at least partial and temporal relief by activity

boolean

C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0035253 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
C0564405 (UMLS CUI [2,3])

Restless Legs Syndrome, Symptoms, Temporal periods of day

Item

The International RLS Study Group Criteria* defines RLS patients as having symptoms worse in the evening or night.

boolean

C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])

Demography

Item Group

Demography

C0011298 (UMLS CUI-1)

Patient date of birth

Item

Date of Birth

date

C0421451 (UMLS CUI [1])

Gender

Item

Gender

text

C0079399 (UMLS CUI [1])

undefined item

Code List

Gender

CL Item

Male (1)

CL Item

Female (2)

Racial group

Item

Race

text

C0034510 (UMLS CUI [1])

Racial group

Code List

Race

CL Item

White (1)

CL Item

Black (2)

CL Item

Oriental (3)

CL Item

Other, specify: (4)

Vital Signs

Item Group

Vital Signs

C0518766 (UMLS CUI-1)

Body Height

Item

Height (without shoes)

text

C0005890 (UMLS CUI [1])

Body Height

Code List

Height (without shoes)

CL Item

cm (1)

CL Item

in (2)

Body Height

Item

Height (without shoes)

float

C0005890 (UMLS CUI [1])

Body Weight

Item

Weight (without shoes)

text

C0005910 (UMLS CUI [1])

Body Weight

Code List

Weight (without shoes)

CL Item

kg (1)

CL Item

lbs (2)

Body Weight

Item

Weight (without shoes)

float

C0005910 (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) - Diastolic

integer

C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])

Taking orthostatic vital signs

Item Group

Orthostatic Vital Signs

C1827287 (UMLS CUI-1)

Semi-erect; Vital Signs Time

Item

After 10 minutes semi-supine - Time Vitals Taken

time

C0522019 (UMLS CUI [1,1])
C2826762 (UMLS CUI [1,2])

Semi-erect; Systolic Pressure

Item

After 10 minutes semi-supine - Blood Pressure (systolic)

integer

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

Semi-erect; Diastolic blood pressure

Item

After 10 minutes semi-supine - Blood Pressure (diastolic)

integer

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

Semi-erect; Heart rate

Item

After 10 minutes semi-supine - Pulse

integer

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

Erect, Vital Signs Time

Item

After erect for 1 minute - Time Vitals Taken

time

C0522014 (UMLS CUI [1,1])
C2826762 (UMLS CUI [1,2])

Erect, Systolic Pressure

Item

After erect for 1 minute - Blood Pressure (systolic)

integer

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

Erect, Diastolic blood pressure

Item

After erect for 1 minute - Blood Pressure (diastolic)

integer

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

Erect, Heart rate

Item

After erect for 1 minute - Pulse

integer

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

12 lead ECG

Item Group

Electrocardiogram (12 Lead)

C0430456 (UMLS CUI-1)

12 lead ECG, Date in time

Item

Date of ECG

date

C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

12 lead ECG, Abnormality

Item

Were any clinically significant abnormalities detected?

boolean

C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Physical Examination

Item Group

Physical Examination

C0031809 (UMLS CUI-1)

Laboratory Procedures, Evaluation

Item Group

Laboratory Evaluation

C0022885 (UMLS CUI-1)
C0220825 (UMLS CUI-2)

Collection of blood specimen for laboratory procedure, Date in time

Item

Date of blood sample

date

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

Laboratory Procedures, Laboratory specimen identification label

Item

Please affix the Quest Diagnostics Laboratory label here.

text

C0022885 (UMLS CUI [1,1])
C4273937 (UMLS CUI [1,2])

Laboratory Procedures, Abnormality

Item

Were any clinically significant abnormalities detected?

boolean

C0022885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Urine dipstick test

Item Group

Urine Dipstick

C0430370 (UMLS CUI-1)

Urine dipstick test, Test Result

Item

What was the result of the urine dipstick performed at this visit?

text

C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])

Urine dipstick test, Test Result

Code List

What was the result of the urine dipstick performed at this visit?

CL Item

Negative (1)

CL Item

Positive (2)

Urine pregnancy test

Item Group

Pregnancy Dipstick

C0430056 (UMLS CUI-1)

Childbearing Potential

Item

Is the patient a female of child-bearing potential?

boolean

C3831118 (UMLS CUI [1])

Urine pregnancy test, Test Result

Item

If ’Yes’, please perform a pregnancy dipstick test and record result below.

text

C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])

Urine pregnancy test, Test Result

Code List

If ’Yes’, please perform a pregnancy dipstick test and record result below.

CL Item

Negative (1)

CL Item

Positive (2)

Medical History, History of surgical procedures, Physical Examination

Item Group

Significant Medical/Surgical History and Physical Examination

C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)

Medical History, History of surgical procedures

Item

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

boolean

C0262926 (UMLS CUI [1,1])
C0489540 (UMLS CUI [1,2])

Medical History, Diagnosis; History of surgical procedures, Diagnosis

Item

Diagnosis (Only in the absence of a diagnosis, record the signs and symptoms on separate lines.)

text

C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])

Medical History, Diagnosis, Year; History of surgical procedures, Diagnosis, Year

Item

Year of first diagnosis (if known)

integer

C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0439234 (UMLS CUI [2,3])

Medical History, Diagnosis, Current, Past; History of surgical procedures, Diagnosis, Current, Past

Item

Past / Ongoing

integer

C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1444637 (UMLS CUI [1,4])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
C1444637 (UMLS CUI [2,4])

Medical History, Diagnosis, Current, Past; History of surgical procedures, Diagnosis, Current, Past

Code List

Past / Ongoing

CL Item

Past (1)

CL Item

Ongoing (2)

Prior Medication Usage; Concomitant Agent

Item Group

Prior and Concomitant Medication

C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-3)

Pharmaceutical Preparations

Item

Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?

boolean

C0013227 (UMLS CUI [1])

Pharmaceutical Preparations, Medication name

Item

Drug Name (Trade Name Preferred)

text

C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])

Pharmaceutical Preparations, Daily Dose, Total

Item

Total Daily Dose

text

C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])

Pharmaceutical Preparations, Disease

Item

Medical Illness/ Diagnosis (or symptom in absence of diagnosis)

text

C0013227 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])

Pharmaceutical Preparation, Start Date

Item

Start Date (be as precise as possible)

date

C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Pharmaceutical Preparation, End Date

Item

End Date

date

C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Pharmaceutical Preparations, Continuous

Item

Continuing

boolean

C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

Restless Legs Syndrome, Pharmaceutical Preparations, Medical History

Item Group

RLS Pharmacotherapy History

C0035258 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0262926 (UMLS CUI-3)

Restless Legs Syndrome, Pharmaceutical Preparations, Medical History

Item

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

boolean

C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])

Restless Legs Syndrome, Pharmaceutical Preparations, Medication name

Item

Drug Name (Trade Name Preferred)

text

C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])

Restless Legs Syndrome, Pharmaceutical Preparations, Start Date

Item

Start Date (be as precise as possible)

date

C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])

Restless Legs Syndrome, Pharmaceutical Preparations, End Date

Item

End Date

date

C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])

Restless Legs Syndrome, Pharmaceutical Preparations, Continuous

Item

Continuing

boolean

C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])

Restless Legs Syndrome, Drug Treatment and Response to Therapy

Item

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

text

C0035258 (UMLS CUI [1,1])
C0150839 (UMLS CUI [1,2])

Restless Legs Syndrome, Drug Treatment and Response to Therapy

Code List

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

CL Item

Yes (1)

CL Item

No (2)

CL Item

Unknown (3)

Restless Legs Syndrome, Pharmaceutical Preparations, Physical tolerance to drug

Item

Did the patient tolerate the treatment? (mark one)

text

C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0556444 (UMLS CUI [1,3])

Restless Legs Syndrome, Drug Treatment and Response to Therapy

Code List

Did the patient tolerate the treatment? (mark one)

CL Item

Yes (1)

CL Item

No (2)

CL Item

Unknown (3)

Eligibility Determination

Item Group

Screening Inclusion/Exclusion Criteria

C0013893 (UMLS CUI-1)

Restless Legs Syndrome, Diagnosis

Item

Inclusion - Patients diagnosed with RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms during the previous month. In the case of a patient currently receiving medication for the treatment of RLS, the investigator should use his/her best clinical judgement to assess whether that patient would have suffered from a minimum of 15 nights with RLS symptoms if they had not been taking any medication.

boolean

C0035258 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Age

Item

Inclusion - Patient is ≥ 18 years old and < 80 years of age.

boolean

C0001779 (UMLS CUI [1])

Informed Consent

Item

Inclusion - Patient has given written informed consent prior to any specific study procedures.

boolean

C0021430 (UMLS CUI [1])

Restless Legs Syndrome, Daytime

Item

Exclusion - Patient is suffering from RLS symptoms which require treatment during the daytime (daytime defined as 10.00 until 18.00).

boolean

C0035258 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])

Primary Sleep Disorders

Item

Exclusion - Patient suffers from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).

boolean

C0236991 (UMLS CUI [1])

Movement Disorders

Item

Exclusion - Patient is suffering from a movement disorder (e.g. Parkinson's Disease, dyskinesias or dystonias).

boolean

C0026650 (UMLS CUI [1])

Disease

Item

Exclusion - Patient has medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).

boolean

C0012634 (UMLS CUI [1])

Ropinirole, Intolerance to substance; Dopamine Agonists, Intolerance to substance

Item

Exclusion - Patient has exhibited intolerance to ropinirole or any other dopamine agonist

boolean

C0244821 (UMLS CUI [1,1])
C1744706 (UMLS CUI [1,2])
C0178601 (UMLS CUI [2,1])
C1744706 (UMLS CUI [2,2])

Substance Use Disorders; Substance Dependence

Item

Exclusion - Patient meets DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to Screening.

boolean

C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])

Female, Childbearing Potential, Contraceptive methods

Item

Exclusion - Patient is a woman, of child-bearing potential and is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant).

boolean

C0086287 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])

Female, Pregnancy; Female, Breast Feeding

Item

Exclusion - Patient is a woman who has a positive pregnancy test or is lactating.

boolean

C0086287 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0086287 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])

Disease

Item

Exclusion - Patient has clinically significant or unstable medical conditions which in the opinion of the investigator would render the patient unsuitable for the study (e.g., symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, etc.).

boolean

C0012634 (UMLS CUI [1])

Non-Compliance

Item

Exclusion - Patient who, in the opinion of the Investigator, would be non-compliant with the visit schedule or other study procedures.

boolean

C0457432 (UMLS CUI [1])

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Description

Mots-clés

Versions (2)

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DOI

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Modèle Commentaires :

Groupe Item commentaires pour :

Item commentaires pour :

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

Screening

Description

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