Information:
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ID
16679
Description
QUTENZA™ versus Pregabalin in Subjects with Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0004 Trial Registry Identification Number(#'s) NCT01713426 EudraCT Number: 2011-005872-41
Keywords
Versions (1)
- 7/31/16 7/31/16 -
Uploaded on
July 31, 2016
DOI
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License
Creative Commons BY-NC-ND 3.0
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Screening Procedure QTZ-EC-0004 ELEVATE NCT01713426
Screening Procedure QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Similar models
Screening Procedure QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Visit
Item
Was the visit performed? If No, then all other forms with the Form Not Done field in this visit will be marked not done. If Yes, please provide the Date of Visit:
boolean
C0545082 (UMLS CUI [1])
Date of Visit
Item
Date of Visit:
date
C1320303 (UMLS CUI [1])
Item
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG".
text
C0262926 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG".
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Medical condition
Item
Are there any past or present Medical Conditions?
boolean
C0012634 (UMLS CUI [1])
Medical condition: Specification
Item
If Yes, please provide details:
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Medical condition: Onset Date
Item
Onset Date
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Medical condition: Recovered Date
Item
Is Medical Condition ongoing? If No, please provide "Recivered Date".
boolean
C0012634 (UMLS CUI [1,1])
C1115804 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1115804 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Medical condition: Recovered Date Specification
Item
Is Medical Condition ongoing? If No, please provide "Recivered Date".
date
C0012634 (UMLS CUI [1,1])
C1115804 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1115804 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG".)
text
C0332137 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG".)
CL Item
Done (Done )
CL Item
Not Done (Not Done)
Date of Diagnosis
Item
Date of Diagnosis
date
C2316983 (UMLS CUI [1])
CL Item
Probable Neuropathic Pain (Probable Neuropathic Pain)
CL Item
Definite Neuropathic Pain (Definite Neuropathic Pain)
CL Item
Pain with a distinct neuroanatomically plausible distribution (Pain with a distinct neuroanatomically plausible distribution)
CL Item
A history suggestive of a relevant lesion or disease affecting the peripheral or central somatosenosory system (A history suggestive of a relevant lesion or disease affecting the peripheral or central somatosenosory system)
CL Item
Demonstration of the distinct neuroanatomically plausible distribution by at least one confirmatory test (Demonstration of the distinct neuroanatomically plausible distribution by at least one confirmatory test)
CL Item
Demonstration of the relevant lesion or disease by at least one confirmatory test (Demonstration of the relevant lesion or disease by at least one confirmatory test)
CL Item
Demonstration of negative or positive sensory signs, confined to the innervations territory of the lesioned nervous structure, ba at least one confirmatory test (Demonstration of negative or positive sensory signs, confined to the innervations territory of the lesioned nervous structure, ba at least one confirmatory test)
CL Item
Postherpetic neuralgia (PHN) (Postherpetic neuralgia (PHN))
CL Item
Peripheral nerve injury (PNI) (Peripheral nerve injury (PNI))
CL Item
Non-diabetic painful peripheral polyneuropathy (Non-diabetic painful peripheral polyneuropathy)
Item
If Peripheral Nerve Injury (PNI) is selected, please provide details. Type of Peripheral Nerve Injury (PNI):
text
C0262593 (UMLS CUI [1])
Code List
If Peripheral Nerve Injury (PNI) is selected, please provide details. Type of Peripheral Nerve Injury (PNI):
CL Item
Post-Surgical Neuropathic Pain (Post-Surgical Neuropathic Pain)
CL Item
Post-Traumatic Neuropathic Pain (Post-Traumatic Neuropathic Pain)
CL Item
Other (Other)
Peripheral Nerve Injury: Specification
Item
If "Other", please specify:
text
C0262593 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
If Non-diabetic painful peripheral polyneuropathy is selected, please provide details. Type of peripheral polyneuropathy
text
C0152025 (UMLS CUI [1])
Code List
If Non-diabetic painful peripheral polyneuropathy is selected, please provide details. Type of peripheral polyneuropathy
CL Item
Small-fiber neuropathy as confirmed by quantitative sensory testing (QST) (Small-fiber neuropathy as confirmed by quantitative sensory testing (QST))
CL Item
Small-fiber neuropathy as confirmed by laser evoked potentials (LEP) (Small-fiber neuropathy as confirmed by laser evoked potentials (LEP))
CL Item
Small-fiber neuropathy as confirmed by skin biopsy (Small-fiber neuropathy as confirmed by skin biopsy )
CL Item
Chemotherapy induced neuropathy in subjects with stable neoplastic disease (Chemotherapy induced neuropathy in subjects with stable neoplastic disease)
CL Item
Other, adequately characterized painful peripheral polyneuropathy, based on clinical history and examination (Other, adequately characterized painful peripheral polyneuropathy, based on clinical history and examination)
Peripheral polyneuropathy: Specification
Item
If "Other, adequately characterized painful peripheral polyneuropathy" was selected provide details:
text
C0152025 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Findings and Conditions
Item
Record any abnormal findings/ conditions identified during the exam on the appropriate form. For Screening/ Baseline visits, report abnormal findings/ conditions on the appropriate form (Medical History or Adverse Events). For Post-Baseline visits, record abnormal findings/ conditions that have worsenend from Screening/ Baseline and are clinically significant on the Adverse Event form.
text
C0243095 (UMLS CUI [1])
C1142435 (UMLS CUI [2])
C1142435 (UMLS CUI [2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Vital Signs: Assessment Date
Item
date
C0518766 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
CL Item
Supine (Supine)
CL Item
Sitting (Sitting)
CL Item
Standing (Standing)
Systolic Blood Pressure
Item
Systolic Blood Pressure
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
float
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
float
C0232117 (UMLS CUI [1])
Vital Signs: Comment
Item
Record any abnormal results on the appropriate form. For Screening/Baseline visits, report abnormal results on the appropriate form (Medical History or Adverse Event). For Post-Baseline visits, record abnormal results that have worsened from Screening/ Baseline and are clinicallly significant on the Adverse Event form.
text
C0518766 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Height and Weight: Assessment Date
Item
Assessment Date
date
C0005890 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2,1])
C2985720 (UMLS CUI [2,2])
C2985720 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2,1])
C2985720 (UMLS CUI [2,2])
Height
Item
height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
BMI
Item
BMI
float
C1305855 (UMLS CUI [1])
Item
Form Not Done (Mark Form Not Done only if the entire visit was not done, otherwise provide details below)
text
C0032976 (UMLS CUI [1])
Code List
Form Not Done (Mark Form Not Done only if the entire visit was not done, otherwise provide details below)
CL Item
Done (Done )
CL Item
Not Done (Not Done)
Item
If Pregnancy Test was not done, please provide reason:
text
C0032976 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Female (2 years post-menopausal or surgically sterile) (Female (2 years post-menopausal or surgically sterile))
CL Item
Male (Male)
CL Item
Other (Other)
Pregnancy Test: Reason Specification
Item
If "Other", specify:
text
C0032976 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Pregnancy Test: Date
Item
Date of Sample Taken
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (Negative )
CL Item
Positive (Positive)
CL Item
Done (Done )
CL Item
Not Done (Not Done)
Samples Taken
Item
Were samples taken?
boolean
C1277698 (UMLS CUI [1])
Date of Samples Taken
Item
Date of Sample Taken
date
C0460065 (UMLS CUI [1])
Item
Laboratory Interpretation (If LAB interpretetation is abnormal, please select assessment items below and report the interpretation for each.)
text
C0262707 (UMLS CUI [1])
Code List
Laboratory Interpretation (If LAB interpretetation is abnormal, please select assessment items below and report the interpretation for each.)
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Red Blood Cell (Red Blood Cell)
CL Item
White Blood Cell Count (White Blood Cell Count)
CL Item
Lymphocytes (Lymphocytes)
CL Item
Neutrophils (Neutrophils)
CL Item
Eosinophils (Eosinophils)
CL Item
Basophils (Basophils)
CL Item
Monocytes (Monocytes)
CL Item
Hemoglobin (Hemoglobin)
CL Item
Hematocrit (Hematocrit)
CL Item
Platelets (Platelets)
Item
Laboratory Interpretation Specification
text
C0262707 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Abnormal - not clinically significant (Abnormal - not clinically significant)
CL Item
Abnormal - clinically significant (Abnormal - clinically significant)
Hematology: Comment
Item
Record any clinically significant abnormal findings/conditions identified during the exam on Medical and Surgical History and/ or Adverse Event form.
text
C0474523 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Biochemistry Sample Taken
Item
Were samples taken?
boolean
C0005477 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,2])
Biochemistry Sample Taken Date
Item
Date of Samples Taken
date
C0005477 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Laboratory Interpretation (If Laboratory Interpretation is abnormal, please select assessment items below and report the interpretation for each.)
text
C0438234 (UMLS CUI [1])
Code List
Laboratory Interpretation (If Laboratory Interpretation is abnormal, please select assessment items below and report the interpretation for each.)
CL Item
Normal (Normal )
CL Item
Abnormal (Abnormal)
CL Item
AST (AST)
CL Item
ALT (ALT)
CL Item
Alkaline Phosphatase (Alkaline Phosphatase)
CL Item
TBL (TBL)
CL Item
Sodium (Sodium)
CL Item
Potassium (Potassium)
CL Item
BUN (BUN)
CL Item
Creatinine (Creatinine)
Item
Laboratory Interpretation Specification
text
C0438234 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Abnormal - not clinically significant (Abnormal - not clinically significant )
CL Item
Abnormal - clinically significant (Abnormal - clinically significant)
Biochemistry: Comment
Item
Record any clinically significant abnormal findings/conditions identified during the exam on Medical and Surgical History and/or Adverse Event form.
text
C0005477 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG".)
text
C2032736 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG".)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Painful Area: Assessment Date
Item
Assessment Date
date
C2032736 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Item
Treatment area: Plase tick all that apply
text
C0087111 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,2])
CL Item
Head and Neck (Head and Neck)
CL Item
Arms (Arms)
CL Item
Hands (Hands)
CL Item
Torso (Torso)
CL Item
Legs (Legs)
CL Item
Feet (Feet)
Painful Area Size
Item
Total Painful/ Sensitive area Size
float
C2032736 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
Item
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG".)
text
C1704738 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG".)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Number of contacts for Neuropathic Pains
Item
Number of contacts with a healthcare professional related to neuropathic pain, within last month
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
Number of contacts: Specification
Item
Number of contacts with a healthcare professional for other causes, within the last month
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])