Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch
NCT ID: NCT01416116
Last Updated: 2018-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
122 participants
INTERVENTIONAL
2011-07-06
2012-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tramadol
Tramadol prior to QUTENZA
QUTENZA
topical
Tramadol
oral
Lidocaine
Lidocaine prior to QUTENZA
QUTENZA
topical
Lidocaine
topical
Interventions
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QUTENZA
topical
Lidocaine
topical
Tramadol
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Daily pain score ≥ 4 for average pain both at the Screening Visit and at the Treatment Visit
* Intact, non-irritated, dry skin over the painful area(s) to be treated
Exclusion Criteria
* Past or current history of Type I or Type II diabetes mellitus
* Active malignancy or treatment for malignancy within a year prior to the Treatment Visit
18 Years
90 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Study Manager, Late Phase Clinical Development & Operations
Role: STUDY_DIRECTOR
Astellas Pharma Europe Limited
Locations
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Site 102
Antwerp, , Belgium
Site 103
Genk, , Belgium
Site 101
Roeselare, , Belgium
Site 202
Hradec Králové, , Czechia
Site 203
Olomouc, , Czechia
Site 201
Prague, , Czechia
Site 302
Aalborg, , Denmark
Site 301
Aarhus, , Denmark
Site 402
Cork, , Ireland
Site 403
Galway, , Ireland
Site 404
Galway, , Ireland
Site 401
Limerick, , Ireland
Site 502
Hamar, , Norway
Site 501
Skien, , Norway
Site 603
Košice, , Slovakia
Site 602
Martin, , Slovakia
Site 702
Glasgow, , United Kingdom
Site 701
Liverpool, , United Kingdom
Site 704
Manchester, , United Kingdom
Site 703
Solihull, , United Kingdom
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2010-023258-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
QTZ-EC-0002
Identifier Type: -
Identifier Source: org_study_id
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