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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016458-42 | EudraCT Number |
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The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.
Patients will be divided into 3 groups of approximately equal size. In the first group, patients will receive a QUTENZA patch applied for 30 minutes to the feet; in the second group, patients will receive a QUTENZA patch applied for 60 minutes to the feet. In both these groups patients will also continue to receive their normal treatment (Standard of Care (SOC)) for their peripheral neuropathic pain (PNP) and may receive further QUTENZA patch applications in the same way during the study. The third group will not receive a QUTENZA patch but will continue to receive their normal treatment for their neuropathic pain (SOC). Subjects will be involved in the study for up to 15 months and will have to visit the clinic at least 9 times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Qutenza 30 minutes + SOC | Experimental |
| |
| 2. Qutenza 60 minutes + SOC | Experimental |
| |
| 3. SOC | No Intervention | Subjects randomized to this group will receive treatment optimized for them on an individual basis. The investigator will be free to provide whatever pharmacological or other treatment is considered optimal for management of the subject's pain. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QUTENZA | Drug | A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale | Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing | Physicians measuring neurological function will be blinded to treatment | Baseline till End of Study (up to 64 weeks) |
| Tolerability of patch application by dermal assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Clinical Study Manager | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site: 601 | Bonheiden | 2820 | Belgium | |||
| Site: 903 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27919222 | Derived | Vinik AI, Perrot S, Vinik EJ, Pazdera L, Jacobs H, Stoker M, Long SK, Snijder RJ, van der Stoep M, Ortega E, Katz N. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol. 2016 Dec 6;16(1):251. doi: 10.1186/s12883-016-0752-7. |
| Label | URL |
|---|---|
| Link to results on EudraCT | View source |
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|
| Screening till Last visit when QUTENZA patch is applied (up to 53 weeks) |
| Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application | Assessed within 15 minutes and 60 minutes after patch removal. | Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks) |
| Tolerability of patch application by rescue medication use | Days 1 through 5 after each patch application |
| Adverse Events and serious adverse Events | Screening visit through End of study visit (up to 65 weeks) |
| Vital Signs (heart rate and blood pressure) | In case of patch application to be performed within 15 minutes before topical anesthetic application and within 15 minutes after patch removal. | Screening visit through End of study visit (up to 65 weeks) |
| Laboratory Analyses | The tests performed at the screening visit will include Hematology: Red Blood Cell Count, White Blood Cell Count, Lymphocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Hemoglobin, Hematocrit and Platelets. Biochemistry: Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT), Alkaline Phosphatase, Sodium, Potassium, Blood Urea Nitrogen (BUN), Creatinine and Lipid profile. Subsequent HbA1c and lipid profile follow-up will be done at bi-monthly visits. The other tests will be performed if clinically indicated. | Screening visit through End of study visit (up to 65 weeks) |
| Intensity of neuropathic pain using "average pain" NPRS scores | Question 5 of Brief Pain Inventory-Diabetic Neuropathy (BPI-DN) | Screening visit through End of study visit (up to 65 weeks) |
| Brief Pain Inventory (BPI) pain severity index and pain interference index | Screening visit through End of study visit (up to 65 weeks) |
| Patient Global Impression of Change | After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks) |
| Generic HRQOL measured by European Quality of Life - 5 Dimensions (EQ-5D) questionnaire | After each patch application, from first patch application through End of Study (up to 64 weeks) |
| Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit | End of Study (up to 65 weeks) |
| Beroun |
| 26601 |
| Czechia |
| Site: 910 | Brno | 60200 | Czechia |
| Site: 908 | Choceň | 56501 | Czechia |
| Site: 911 | Litoměřice | 41201 | Czechia |
| Site: 906 | Ostrava | 71000 | Czechia |
| Site: 904 | Polička | 57201 | Czechia |
| Site: 901 | Prague | 14000 | Czechia |
| Site: 902 | Přerov | 75003 | Czechia |
| Site: 909 | Rychnov nad Kněžnou | 51601 | Czechia |
| Site: 207 | Bron | 69677 | France |
| Site: 202 | Paris | 75004 | France |
| Site: 201 | Pierre-Bénite | 69495 | France |
| Site: 206 | Toulouse | 31059 | France |
| Site: 508 | Chiemsee | 83209 | Germany |
| Site: 509 | Cologne | 50937 | Germany |
| Site: 502 | Dresden | 1307 | Germany |
| Site: 501 | Falkensee | 14612 | Germany |
| Site: 514 | Frankfurt | 60311 | Germany |
| Site: 507 | Hamburg | 22177 | Germany |
| Site: 505 | Leipzig | 04109 | Germany |
| Site: 506 | Münster | 48145 | Germany |
| Site: 512 | Wangen | 88239 | Germany |
| Site: 404 | Milan | 20162 | Italy |
| Site: 401 | Roma | 00133 | Italy |
| Site: 651 | Utrecht | 3584 CX | Netherlands |
| Site: 965 | Bialystok | 15435 | Poland |
| Site: 961 | Bydgoszcz | 85822 | Poland |
| Site: 957 | Elblag | 82300 | Poland |
| Site: 958 | Gdynia | 81049 | Poland |
| Site: 954 | Katowice | 40954 | Poland |
| Site: 964 | Krakow | 31530 | Poland |
| Site: 951 | Lodz | 90153 | Poland |
| Site: 966 | Lubin | 59300 | Poland |
| Site: 953 | Poznan | 61655 | Poland |
| Site: 959 | Torun | 87100 | Poland |
| Site: 960 | Warsaw | 1868 | Poland |
| Site: 714 | Kemerovo | 150062 | Russia |
| Site: 703 | Saint Petersburg | 191015 | Russia |
| Site: 716 | Saint Petersburg | 194358 | Russia |
| Site: 704 | Saint Petersburg | 79117120826 | Russia |
| Site: 706 | Saint Petersburg | 79117778999 | Russia |
| Site: 708 | Samara | 79117778999 | Russia |
| Site: 709 | Saratov | 79117120826 | Russia |
| Site: 713 | Tomsk | 79117778999 | Russia |
| Site: 711 | Yaroslavl | 79117778999 | Russia |
| Site: 303 | Valencia | 46010 | Spain |
| Site: 304 | Valencia | 46014 | Spain |
| Site: 305 | Valladolid | 47012 | Spain |
| Site: 808 | Chernihiv | 14034 | Ukraine |
| Site: 803 | Kharkiv | 61037 | Ukraine |
| Site: 812 | Kvuv | 79010 | Ukraine |
| Site: 805 | Kyiv | 2091 | Ukraine |
| Site: 807 | Kyiv | 4053 | Ukraine |
| Site: 806 | Kyiv | 4114 | Ukraine |
| Site: 810 | Lviv | 79010 | Ukraine |
| Site: 802 | Mykolayiv | 54003 | Ukraine |
| Site: 801 | Odesa | 65009 | Ukraine |
| Site: 813 | Vinnitsa | 21010 | Ukraine |
| Site: 815 | Zaporizhzhya | 69001 | Ukraine |
| Site: 102 | Chorley | PR7 1PP | United Kingdom |
| Site: 103 | Liverpool | L7 8XP | United Kingdom |
| Site: 104 | Poole | BH15 2JB | United Kingdom |
| Site: 101 | Rugby | CV22 5PX | United Kingdom |
| Link to results on Astellas Clinical Study Results Web site | View source |
| ID | Term |
|---|---|
| D002211 | Capsaicin |
| 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 |
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