Predose Checklist - Instructions: Please mark appropriateanswer to the following questions. If the answer to all the questions is YES then dosing may proceed.
Date of last RLS medication
boolean
Last Alcohol Consumption
boolean
Alcohol consumption
boolean
Strenuous Exercise
boolean
Smoking Status
boolean
Caffeinated beverage
boolean
OTC or herbal remedies
boolean
Concomitant Medication
boolean
RLS Rating Scale
Prior Medication
If 'YES', please record the medication below. NB: Any medications Metabolised by CYP1A2 must be kept constant through out the study.
boolean
Drug name
text
Dose
text
Medication Frequency
text
Administration Route
text
Duration of Therapy
text
End Date
date
Continuing
boolean
Pregnancy Test (Females only)
Pregnancy Test
boolean
Reason for Pregnancy Test
text
Date of Pregnany Test
date
If 'POSITIVE', withdraw the subject from the study.
text
Vital Signs - Instructions: Semi-supine recordings must be made after the patient has been resting semi-supine for at least 10 min & erect measurments will be taken after the patients has been erect for a period of 1 min. Three sets of stable semi-supine and errect vital signs must be recorded pre-dose with the patient resting fro 10 min semi-supine between each set. In this instance 'stable' is defined at all measurements being within 15 mmHg of the lowest measurements for each and every parameter e.g. semi-supine diastolic. - The blood pressure cuff must be placed on the same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
Date of Examination: Pre-Dose
date
Time of Examination: Pre-Dose
time
Semi-supine Systolic Blood Pressure: Pre-Dose
float
Semi-supine Diastolic Blood Pressure: Pre-Dose
float
Semi-supine Heart Rate: Pre-Dose
float
Erect Systolic Blood Pressure: Pre-Dose
float
Erect Diastolic Blood Pressure: Pre-Dose
float
Erect Heart Rate: Pre-Dose
float
Baseline Signs and Symptoms - Please note any SERIOUS events should be recorded on this page, but on the Serious Adverse Event pages provided. Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to subject: "How do you feel?" Provide the diagnosis, NOT symptoms where possible. (One baseline event per column)
No Baseline Signs and Symptoms
boolean
Baseline Signs and Symptoms
text
Date of Onset
date
Time of Onset
time
End Date of Baseline Signs and Symptoms
date
End Time of Baseline Signs and Symptoms
time
* If subject died, please inform GSK within 24 hours and complete Form D
text
Event Course
text
Number of Episodes
integer
MILD = The event which is easily tolerated MODERATE = An event which is sufficiently discomforting to interfere with daily activity SEVERE = An event which prevents normal everyday activities
text
NOT RELATED = The event is definetly not related to the study procedures UNLIKELY = There are other more likely causes and the study procedures are not suspected as a cause SUSPECTEED (REASONABLE POSSIBILITY) = A direct cause and effect relationship between the study procedures and the event has not been demonstrated but there is a reasonable possibility that the study procedures were involved PROBABLE = There probably is a direct cause and effect relationship beween and the study procedures
text
Corrective Therapy
boolean
Withdrawal
boolean
Dosing Details
Afternoon meal
boolean
Date of last food intake
date
Time of last food intake
time
Date of Dosing
date
Time of Dosing
time
Container Number
text
Label
text
Dose Level
text
Doctor's Name
text
Vital Signs Instructions: For each set, semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measurements will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
Study time: Post-Dose
text
Date of Examination: Post-Dose
date
Time of Examination: Post-Dose
time
Semi-supine Systolic Blood Pressure: Post-Dose
float
Semi-supine Diastolic Blood Pressure: Post-Dose
float
Semi-supine Heart Rate: Post-Dose
float
Erect Systolic Blood Pressure: Post-Dose
float
Erect Diastolic Blood Pressure: Post-Dose
boolean
Erect Heart Rate: Post-Dose
float
Adverse Event - Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis NOT symptoms where possible.
Study Protocol
Y - Ensure patient returns home with their study medication and diary card. N - Select a dosing strategy from options below and tick the relevant box.
text
TRY AGAIN - Patient will receive the next days dose in the clinic. COmplete an Extra Clinic Visit section of the CRF for this visit. MTD DETERMINED - No further attempts at up titration will be made. Ensure patient returns home with medication for the previous dose level and diary card. Schedule the Last Visit (6 days later) so patients receive their last dose in the clinic. Complete Last Clinic Visit section in the CRF.
text