A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients
NCT ID: NCT01478607
Last Updated: 2015-10-14
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
PHASE3
468 participants
INTERVENTIONAL
2011-11-30
2014-02-28
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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1. Qutenza 30 minutes + SOC
QUTENZA
A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).
2. Qutenza 60 minutes + SOC
QUTENZA
A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).
3. SOC
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.
No interventions assigned to this group
Interventions
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QUTENZA
A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable glycemic control for at least 6 months prior to screening visit
* Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of \>4 at the screening and the baseline visit
Exclusion Criteria
* Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN
* Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain
* Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study.
* Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter \[OTC\] capsaicin products), any QUTENZA excipients, Eutectic Mixture of Local Anesthetics( EMLA) ingredients or adhesives
18 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 Clinical Study Manager
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Site: 601
Bonheiden, , Belgium
Site: 903
Beroun, , Czechia
Site: 910
Brno, , Czechia
Site: 908
Choceň, , Czechia
Site: 911
Litoměřice, , Czechia
Site: 906
Ostrava, , Czechia
Site: 904
Polička, , Czechia
Site: 901
Prague, , Czechia
Site: 902
Přerov, , Czechia
Site: 909
Rychnov nad Kněžnou, , Czechia
Site: 207
Bron, , France
Site: 202
Paris, , France
Site: 201
Pierre-Bénite, , France
Site: 206
Toulouse, , France
Site: 508
Chiemsee, , Germany
Site: 509
Cologne, , Germany
Site: 502
Dresden, , Germany
Site: 501
Falkensee, , Germany
Site: 514
Frankfurt, , Germany
Site: 507
Hamburg, , Germany
Site: 505
Leipzig, , Germany
Site: 506
Münster, , Germany
Site: 512
Wangen, , Germany
Site: 404
Milan, , Italy
Site: 401
Roma, , Italy
Site: 651
Utrecht, , Netherlands
Site: 965
Bialystok, , Poland
Site: 961
Bydgoszcz, , Poland
Site: 957
Elblag, , Poland
Site: 958
Gdynia, , Poland
Site: 954
Katowice, , Poland
Site: 964
Krakow, , Poland
Site: 951
Lodz, , Poland
Site: 966
Lubin, , Poland
Site: 953
Poznan, , Poland
Site: 959
Torun, , Poland
Site: 960
Warsaw, , Poland
Site: 714
Kemerovo, , Russia
Site: 703
Saint Petersburg, , Russia
Site: 716
Saint Petersburg, , Russia
Site: 704
Saint Petersburg, , Russia
Site: 706
Saint Petersburg, , Russia
Site: 708
Samara, , Russia
Site: 709
Saratov, , Russia
Site: 713
Tomsk, , Russia
Site: 711
Yaroslavl, , Russia
Site: 303
Valencia, , Spain
Site: 304
Valencia, , Spain
Site: 305
Valladolid, , Spain
Site: 808
Chernihiv, , Ukraine
Site: 803
Kharkiv, , Ukraine
Site: 812
Kvuv, , Ukraine
Site: 805
Kyiv, , Ukraine
Site: 807
Kyiv, , Ukraine
Site: 806
Kyiv, , Ukraine
Site: 810
Lviv, , Ukraine
Site: 802
Mykolayiv, , Ukraine
Site: 801
Odesa, , Ukraine
Site: 813
Vinnitsa, , Ukraine
Site: 815
Zaporizhzhya, , Ukraine
Site: 102
Chorley, , United Kingdom
Site: 103
Liverpool, , United Kingdom
Site: 104
Poole, , United Kingdom
Site: 101
Rugby, , United Kingdom
Countries
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References
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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.
Related Links
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Link to results on EudraCT
Link to results on Astellas Clinical Study Results Web site
Other Identifiers
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2009-016458-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E05-CL-3002
Identifier Type: -
Identifier Source: org_study_id
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