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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023258-34 | EudraCT Number |
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The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.
All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7 days to monitor pain scores and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol | Experimental | Tramadol prior to QUTENZA |
|
| Lidocaine | Experimental | Lidocaine prior to QUTENZA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QUTENZA | Drug | topical |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who tolerate QUTENZA treatment | A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration. | 60 minute application period |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of patch application | 60 minutes | |
| Change in pain scores from baseline to subsequent timepoints on the day of patch application | 5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Study Manager, Late Phase Clinical Development & Operations | Astellas Pharma Europe Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 102 | Antwerp | Belgium | ||||
| Site 103 |
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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| Lidocaine | Drug | topical |
|
| Tramadol | Drug | oral |
|
| Proportion of subjects using pain medications and dose of pain medication(s) administered | day 1-5 |
| Subject rated tolerability score | Baseline to end of study visit, day 7 |
| 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 |
| ID | Term |
|---|---|
| D059348 | Peripheral Nerve Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| D057968 | Transdermal Patch |
| D008012 | Lidocaine |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004864 | Equipment and Supplies |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
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