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25282
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Study ID: 101468/191 Clinical Study ID: SKF-101468/191 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS) 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
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- 30.08.17 30.08.17 -
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GlaxoSmithKline
Hochgeladen am
30. August 2017
DOI
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Screening (Form 1)
GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Screening (Form 1)
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Screening (Form 1)
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Center number
Item
Center number
text
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Visit Date
Item
Visit Date
date
1. How old was the patient at the onset of RLS?
Item
1. How old was the patient at the onset of RLS?
integer
Item
2. Did the patient start any new medication near the time of their onset of RLS symptoms that may have caused RLS?
text
Code List
2. Did the patient start any new medication near the time of their onset of RLS symptoms that may have caused RLS?
CL Item
No (1)
CL Item
Yes (please specify below) (2)
Specification of medication
Item
If yes, please specify medication
text
Item
3. If female, did RLS symptoms develop during pregnancy?
text
Code List
3. If female, did RLS symptoms develop during pregnancy?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item
4. Has the patient ever had PLMS (Periodic Leg Movements of Sleep)?
text
Code List
4. Has the patient ever had PLMS (Periodic Leg Movements of Sleep)?
CL Item
No (1)
CL Item
Yes (please answer the following question) (2)
If yes, how old was the patient at the onset of PLMS?
Item
If yes, how old was the patient at the onset of PLMS?
integer
CL Item
No (1)
CL Item
Yes (please answer the following question) (2)
How many units per week?
Item
How many units per week?
integer
Item
6. Does the patient drink caffeine (coffee, tea, cafeeinated drinks)?
text
Code List
6. Does the patient drink caffeine (coffee, tea, cafeeinated drinks)?
CL Item
No (1)
CL Item
Yes (please specify below) (2)
Amount of caffeine
Item
If yes, please specify amount
integer
Item
7. Does the patient have any sleep disorder as defined by DSM IV?
text
Code List
7. Does the patient have any sleep disorder as defined by DSM IV?
CL Item
No (1)
CL Item
Yes -> If "Yes" please record on the Significant Medical/Surgical History and Physical Examination page. (2)
Item
8. Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
text
Code List
8. 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)
Item
9. Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of PLMS?
text
Code List
9. 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)
Item
10. Are the patient´s current symptoms mainly present...
text
Code List
10. Are the patient´s current symptoms mainly present...
CL Item
At nightime only (1)
CL Item
In evening and nighttime (2)
CL Item
Daytime, evening and nighttime (3)
1)...a desire to move the limbs usually associated with parethesias or dysesthesias
Item
1)...a desire to move the limbs usually associated with parethesias or dysesthesias
boolean
2)...motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
Item
2)...motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
boolean
3) ...symptoms worse or exclusively present at rest with at least partial or temporal relief by activity
Item
3) ...symptoms worse or exclusively present at rest with at least partial or temporal relief by activity
boolean
4) ...symptoms worse in the evening or night
Item
4) ...symptoms worse in the evening or night
boolean
Date of birth
Item
Date of birth
date
CL Item
Male (1)
CL Item
Female (2)
CL Item
White (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other (please specify) (4)
Specification of race
Item
If other race please specify
text
Height
Item
Height
float
Weight
Item
Weight
float
Pulse
Item
Pulse (after 5 minutes sitting)
integer
Blood pressure after 10 minutes semi-supine (systolic)
Item
Blood pressure after 10 minutes semi-supine (systolic)
integer
Blood pressure after 10 minutes semi-supine (diastolic)
Item
Blood pressure after 10 minutes semi-supine (diastolic)
integer
After 10 minutes semi-supine Pulse
Item
After 10 minutes semi-supine Pulse
integer
Blood pressure after erect for 1 minute (systolic)
Item
Blood pressure after erect for 1 minute (systolic)
integer
Blood pressure after erect for 1 minute (diastolic)
Item
Blood pressure after erect for 1 minute (diastolic)
integer
Pulse after erect for 1 minute
Item
Pulse after erect for 1 minute
integer
Date of ECG
Item
Date of ECG
date
Item
Were any clinically significant abnormalities detected?
text
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes -> If "yes", please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and repeat prior to baseline. (2)
Physical Examination
Item
Please perform a full physical examination and record any clinically significant abnormality on the Significant Medical/Surgical History and Physical Examination Page. Physical Examination compleated?
boolean
Date of blood sample
Item
Date of blood sample
date
Item
Were any clinically significant abnormalities detected?
text
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes -> If "Yes", please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and repeat prior to baseline. (2)
Item
Is the patient a female of childbearing potential?
text
Code List
Is the patient a female of childbearing potential?
CL Item
No (1)
CL Item
Yes -> If "yes", please perform a pregnancy dipstick test and record result below. (2)
CL Item
Negative (1)
CL Item
Positive -> If "positive", please record details on the Significant Medical/Surgical History and Physical Examination and exclude the patient. (2)
Item Group
Significant medical/surgical history and physical examination
Item
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition other than RLS or PLMS?
text
Code List
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition other than RLS or PLMS?
CL Item
No (1)
CL Item
Yes -> If "Yes", please list below one diagnosis per line (2)
Diagnosis
Item
Diagnosis
text
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
CL Item
Past (1)
CL Item
Ongoing (2)
Item
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS or PLMS) in the 3 month prior to study entry?
text
Code List
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS or PLMS) in the 3 month prior to study entry?
CL Item
No (1)
CL Item
Yes -> If "Yes", please record details below. (2)
Drug Name
Item
Drug Name (Trade Name Preferred)
text
Total Daily Dose
Item
Total Daily Dose
text
Medical Illness/Diagnosis
Item
Medical Illness/Diagnosis
text
Start Date
Item
Start Date (be as precise as possible)
date
End Date
Item
End Date (answer next question if Continuing)
boolean
Medication continuing?
Item
Medication continuing?
boolean
Item
Has the patient taken any pharmacotherapy medication for treatment of RLS?
text
Code List
Has the patient taken any pharmacotherapy medication for treatment of RLS?
CL Item
No (1)
CL Item
Yes -> If "Yes", please record details below (2)
Drug Name
Item
Drug Name (Trade Name Preferred)
text
Start Date
Item
Start Date (be as precise as possible)
date
End Date
Item
End Date (or if continuing answer next question)
date
Medication continuing?
Item
Medication continuing?
boolean
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
IRLSSG diagnostic criteria
Item
1. Male or female subjects diagnosed with RLS using IRLSSG diagnostic criteria with a recent history of a minimum of 15 nights of RLS symptoms per month. Note: For a subject already receiving medication for RLS, the investigator should use their clinical judgement to decide whether that subject would suffer from a minimum of 15 nights with RLS symptoms if they were not taking any medication.
boolean
Clinically significant complaints
Item
2. Subjects must have reported clinically significant complaints of either sleep disruption or daytime consequences associated with the sleep disturbance.
boolean
Inclusion age
Item
3. Subjects >18 years and <80 years of age.
boolean
Contraception
Item
4. Women of child-bearing potential who are practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant). Please refer to document: CD-5.5, Informed Consent (Phase I-IV), section entitled ‘Recommendations For Use of Women Of Childbearing Potential in Clinical Research Studies for SmithKline Beecham’.
boolean
written informed consent
Item
5. The subject must have given written informed consent prior to any specific study procedure.
boolean
Information
Item
Usage Information seen
boolean
RLS symptoms
Item
1. Subjects suffering from RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)
boolean
Dissomnia or Parasomnia
Item
2. Subjects who suffer from a dissomnia or parasomnia other than RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, apnea/hypopnea index >5 per hour during total sleep time and a total oxygen saturation of <80%).
text
Movement disorders
Item
3. Subjects suffering from movement disorders (e.g. Parkinson´s Disease, dyskinesias, and dystonias).
boolean
Symptoms which could affect assessments of efficacy
Item
4. Subjects who have medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).
boolean
change in dose of hormone replacement
Item
5. Subjects who have had withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, fluvoxamine, cimetidine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment.
boolean
intolerance to dopamine agonist
Item
6. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.
boolean
substance abuse
Item
7. Subjects who meet DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within six month prior to screening.
boolean
Pergnancy/lactating
Item
8. Woman who have a positive pregnancy test or who are lactating.
boolean
Subject unsuitable for study
Item
9. Subjects who have clinically significant or unstable medical conditions which in the opinion of the investigator would render the subject unsuitable for the study (e.g. severe cardiovascular disease, symptomatic orthostatic hypotension, hepatic or renal failure, etc.).
text
non-compliance with the visit schedule or other study procedures
Item
10. Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures.
boolean
participation in any clinical drug or device trial
Item
11. Participation in any clinical drug or device trial in the three month prior to the screening visit.
boolean
Information
Item
Usage Information
boolean
12 lead ECG
Item
Date of ECG.
date
Item
Were any clinically significant abnormalities detected?
text
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes -> If yes, please record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study. (2)
Repeat physical examination
Item
If any abnormality was present at screening please perform a physical examination. If there are any significant abnormal findings record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study.
text
Repeat laboratory evaluation
Item
Date of sample
date
Item
Were any clinically significant abnormalities detected?
text
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes -> If "yes", please record the findings and/or diagnosis in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study. (2)
Patient activity postcard
Item
Please complete the patient activity postcard for Screening Repeat Tests located in the poastcard section of this CRF. Detach the postcard and mail promptly. Postage has been prepaid.
text