Informações:
Falhas:
ID
16790
Descrição
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
Palavras-chave
Versões (1)
- 07/08/2016 07/08/2016 -
Transferido a
7 de agosto de 2016
DOI
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Licença
Creative Commons BY-NC-ND 3.0
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Cumulative QTZ-EC-0004 ELEVATE NCT01713426
Cumulative QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Similar models
Cumulative QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item
Form Not Done (Form Not Done should only be akred for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
text
C0013227 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be akred for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Previous and concomitant medication
Item
Are there any previous medications (concomitant treatment taken within 30 days of the Screening Visit) and/or concomitant medications to record?
boolean
C2826667 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
Pregabalin or Gabapentin
Item
Did the patient receive treatment with Pregabalin or Gabapentin at any time prior to the screening visit? (If Yes, please record treatment details below and also provide justificatin of inadequate trial)
boolean
C0657912 (UMLS CUI [1])
C0060926 (UMLS CUI [2])
C0060926 (UMLS CUI [2])
Pregabalin or Gabapentin: Justificaation
Item
For previous use of Pregabalin or Gabapentin, specify the justification of inadequate trial:
text
C0657912 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0060926 (UMLS CUI [2,1])
C0566251 (UMLS CUI [2,2])
C0566251 (UMLS CUI [1,2])
C0060926 (UMLS CUI [2,1])
C0566251 (UMLS CUI [2,2])
Medication: Specification
Item
Medication
text
C0013227 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Oral (Oral)
CL Item
Intravenous (Intravenous)
CL Item
Topical (Topical)
CL Item
Nasogastric (Nasogastric)
CL Item
Subcutaneaous (Subcutaneaous)
CL Item
Intramuscular (Intramuscular)
CL Item
Auricular (Otic) (Auricular (Otic))
CL Item
Ophthalmic (Ophthalmic)
CL Item
Sublingual (Sublingual)
CL Item
Respiratory (Inhalation) (Respiratory (Inhalation))
CL Item
Nasal (Nasal)
CL Item
Transdermal (Transdermal)
CL Item
Vaginal (Vaginal)
CL Item
Rectal (Rectal)
CL Item
Epidural (Epidural)
CL Item
Intrathecal (Intrathecal)
CL Item
Intra-Articular (Intra-Articular)
CL Item
Periarticular (Periarticular)
CL Item
Intraperitoneal (Intraperitoneal)
CL Item
Intradermal (Intradermal)
CL Item
Intra-arterial (Intra-arterial)
CL Item
Urethral (Urethral)
CL Item
Other (Other)
Medication: Other
Item
If "Other", specify:
text
C0013227 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C0549178 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Pain Medication
Item
Pain Medication (If Pain Medication is Yes, please select one of below options.)
boolean
C0002771 (UMLS CUI [1])
Pain Medication: Neuropathic Pain Chronic
Item
Medication to treat neuropathic pain - chronic treatment
boolean
C0002771 (UMLS CUI [1,1])
C3714625 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C3714625 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Pain Medication: Neuropathic Pain Acute
Item
Medication to treat neuropathic pain - acute treatment
boolean
C0002771 (UMLS CUI [1,1])
C3714625 (UMLS CUI [1,2])
C0205178 (UMLS CUI [1,3])
C3714625 (UMLS CUI [1,2])
C0205178 (UMLS CUI [1,3])
Pain Medication: Post-application pain
Item
Medication to treat post-application pain (QUTENZA arm only)
boolean
C0002771 (UMLS CUI [1,1])
C0185125 (UMLS CUI [1,2])
C0185125 (UMLS CUI [1,2])
Pain Medication: Non-Neuropathic Pain
Item
Medication to treat non-neuropathic pain
boolean
C0002771 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
C1518422 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1])
CL Item
ug (ug)
CL Item
ug/h (ug/h)
CL Item
mg (mg)
CL Item
g (g)
CL Item
Other (Other)
Item
If "Other", specify:
text
C2826646 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item Group
Non-Medication Therapy
C0087111 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
C0013227 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
Item
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
text
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
C0884358 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
C0884358 (UMLS CUI [1,4])
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)
Non-Medication Therapy
Item
Is there any non-medication therapy and/or changes in non-medication therapy to record?
boolean
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
Therapy Details
Item
Therapy Details:
text
C0087111 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Start Date of Therapy
Item
Start Date of Therapy
date
C3173309 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C0549178 (UMLS CUI [1])
Stop Date of Therapy
Item
Stop Date of Therapy
date
C1707480 (UMLS CUI [1])
Pain related non-medication therapy
Item
Pain related non-medication therapy
boolean
C0030193 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1518422 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1518422 (UMLS CUI [1,4])
CL Item
Neuropathic Pain (Neuropathic Pain)
CL Item
Post Patch Application Pain (Post Patch Application Pain)
CL Item
Other Pain (Other Pain)
Item
If "Other", specify:
text
C0392360 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (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
C0877248 (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)
Adverse Event: Report
Item
Were any adverse events reported or observed?
boolean
C0877248 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
Adverse Event: Specification
Item
Adverse Event
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Onset Date
Item
Onset Date
date
C0574845 (UMLS CUI [1])
Onset Time
Item
Onset Time (00:00 - 23:59)
time
C0449244 (UMLS CUI [1])
Item
If the onset date is the same day as study drug start date or if a complete onset is unknown and/or if the date and time are unknown, please select one.
text
C0574845 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Code List
If the onset date is the same day as study drug start date or if a complete onset is unknown and/or if the date and time are unknown, please select one.
CL Item
Onset before first dose of study drug (Onset before first dose of study drug)
CL Item
Onset after first dose of study drug (Onset after first dose of study drug)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time (00:00 - 23:59)
time
C1522314 (UMLS CUI [1])
Item
Outcome (If "Outcome" is FATAL, complete the "Adverse Events" form.)
text
C1705586 (UMLS CUI [1])
Code List
Outcome (If "Outcome" is FATAL, complete the "Adverse Events" form.)
CL Item
Recovered/Resolved (Recovered/Resolved)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/not resolved (Not recovered/not resolved)
CL Item
Recovered/Resolved with sequelae (Recovered/Resolved with sequelae)
CL Item
Fatal (Fatal)
CL Item
Unknown (Unknown)
CL Item
Single Episode (Single Episode)
CL Item
Intermittent (Intermittent)
CL Item
Continuous (Continuous)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Serious Adverse Event
Item
Serious AE? (If "Serious AE?" is Yes, select all that apply.) (In case of a serious adverse event (SAE), complete a SAE report)
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event: Number
Item
Serious Adverse Event Number
float
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Death
Item
Death
boolean
C0011065 (UMLS CUI [1])
Hospitalization
Item
Requires or prolongs hospitalization
boolean
C0019993 (UMLS CUI [1])
Congenital anomaly
Item
Congenital anomaly
boolean
C2826727 (UMLS CUI [1])
Life-threatening
Item
Life-threatening
boolean
C2826244 (UMLS CUI [1])
Disability
Item
Persistent or significant disability/Incapacity
boolean
C0231170 (UMLS CUI [1])
Medical Importance
Item
Other medical importance
boolean
C0205476 (UMLS CUI [1,1])
C1705104 (UMLS CUI [1,2])
C1705104 (UMLS CUI [1,2])
Item
Action Taken for Study Drug (If "Action Taken for Study Drug" is DRUG WITHDRAWN, complete the "End of Treatment and Study" form/ "End of Treatment" form.
text
C2826626 (UMLS CUI [1])
Code List
Action Taken for Study Drug (If "Action Taken for Study Drug" is DRUG WITHDRAWN, complete the "End of Treatment and Study" form/ "End of Treatment" form.
CL Item
Dose not changed (Dose not changed)
CL Item
Dose increased (Dose increased)
CL Item
Dose reduced (Dose reduced)
CL Item
Drug interrupted (Drug interrupted)
CL Item
Drug withdrawn (Drug withdrawn)
CL Item
Unknown (Unknown)
CL Item
Not applicable (Not applicable)
Adverse Event: Treatment
Item
Was there any treatment required? (If Yes, please select all that apply.)
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Adverse Event: Medication Therapy
Item
Medication Therapy (If "Medication Therapy" is Yes, complete the "Previous and Concomitant Medications" form.)
boolean
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Adverse Event: Non-Medication Therapy
Item
Non-Medication Therapy (If "Non-Medication Therapy" is Yes, complete the "Non-Medication Therapy" form.)
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1518422 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1518422 (UMLS CUI [1,4])
Item
Relationship to Study Drug
text
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
CL Item
Not related (Not related)
CL Item
Possible (Possible)
CL Item
Probable (Probable)
Adverse Event: Application site reaction
Item
Please confirm if the Adverse Event is an Application site reaction.
boolean
C0877248 (UMLS CUI [1,1])
C0151505 (UMLS CUI [1,2])
C0151505 (UMLS CUI [1,2])
Serious Adverse Event: Date
Item
Date Serious Adverse Event Reconciled (For Astellas Use Only!)
date
C1519255 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Administration of Pregabalin
C0657912 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
C1533734 (UMLS CUI-2)
Item
Form Not Done (Please record every change in the dosing of Pregabalin in a new log line, providing Start and Stop Date)
text
C0657912 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,2])
Code List
Form Not Done (Please record every change in the dosing of Pregabalin in a new log line, providing Start and Stop Date)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Dosing Start Date
Item
Dosing Start Date
date
C3173309 (UMLS CUI [1])
Dosing Stop Date
Item
Dosing Stop Date
date
C1115730 (UMLS CUI [1])
Total Capsules: Daily amount
Item
# of Total Capsules Taken Daily
float
C0006935 (UMLS CUI [1,1])
C2826638 (UMLS CUI [1,2])
C2826638 (UMLS CUI [1,2])