Clinical trial NCT01478607: A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients
Official title: A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZATM Plus Standard of Care Versus Standard of Care Alone in Subjects With Painful Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Painful Diabetic Peripheral Neuropathy (PDPN)
Keywords: Painful Diabetic Peripheral Neuropathy
Qutenza
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-11-23
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes
* 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:

* Primary pain associated with PDPN in the ankles or above
* 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

Primary outcomes:
measure: Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale
timeFrame: Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)
Secondary outcomes:
measure: Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing
timeFrame: Baseline till End of Study (up to 64 weeks)
measure: Tolerability of patch application by dermal assessment
timeFrame: Screening till Last visit when QUTENZA patch is applied (up to 53 weeks)
measure: Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application
timeFrame: Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks)
measure: Tolerability of patch application by rescue medication use
timeFrame: Days 1 through 5 after each patch application
measure: Adverse Events and serious adverse Events
timeFrame: Screening visit through End of study visit (up to 65 weeks)
measure: Vital Signs (heart rate and blood pressure)
timeFrame: Screening visit through End of study visit (up to 65 weeks)
measure: Laboratory Analyses
timeFrame: Screening visit through End of study visit (up to 65 weeks)
measure: Intensity of neuropathic pain using "average pain" NPRS scores
timeFrame: Screening visit through End of study visit (up to 65 weeks)
measure: Brief Pain Inventory (BPI) pain severity index and pain interference index
timeFrame: Screening visit through End of study visit (up to 65 weeks)
measure: Patient Global Impression of Change
timeFrame: After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks)
measure: Generic HRQOL measured by European Quality of Life - 5 Dimensions (EQ-5D) questionnaire
timeFrame: After each patch application, from first patch application through End of Study (up to 64 weeks)
measure: Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit
timeFrame: End of Study (up to 65 weeks)
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Site: 601
city: Beroun
country: Czech Republic
facility: Site: 903
city: Brno
country: Czech Republic
facility: Site: 910
city: Chocen
country: Czech Republic
facility: Site: 908
city: Litomerice
country: Czech Republic
facility: Site: 911
city: Ostrava
country: Czech Republic
facility: Site: 906
city: Policka
country: Czech Republic
facility: Site: 904
city: Praha 4
country: Czech Republic
facility: Site: 901
city: Prerov
country: Czech Republic
facility: Site: 902
city: Rychnov nad Kneznou
country: Czech Republic
facility: Site: 909
city: Bron
country: France
facility: Site: 207
city: Paris
country: France
facility: Site: 202
city: Pierre Benite
country: France
facility: Site: 201
city: Toulouse
country: France
facility: Site: 206
city: Chiemsee
country: Germany
facility: Site: 508
city: Dresden
country: Germany
facility: Site: 502
city: Falkensee
country: Germany
facility: Site: 501
city: Frankfurt
country: Germany
facility: Site: 514
city: Hamburg
country: Germany
facility: Site: 507
city: Koln
country: Germany
facility: Site: 509
city: Leipzig
country: Germany
facility: Site: 505
city: Muenster
country: Germany
facility: Site: 506
city: Wangen
country: Germany
facility: Site: 512
city: Milano
country: Italy
facility: Site: 404
city: Roma
country: Italy
facility: Site: 401
city: Utrecht
country: Netherlands
facility: Site: 651
city: Bialystok
country: Poland
facility: Site: 965
city: Bydgoszcz
country: Poland
facility: Site: 961
city: Elblag
country: Poland
facility: Site: 957
city: Gdynia
country: Poland
facility: Site: 958
city: Katowice
country: Poland
facility: Site: 954
city: Krakow
country: Poland
facility: Site: 964
city: Lodz
country: Poland
facility: Site: 951
city: Lubin
country: Poland
facility: Site: 966
city: Poznan
country: Poland
facility: Site: 953
city: Torun
country: Poland
facility: Site: 959
city: Warszawa
country: Poland
facility: Site: 960
city: Kemerovo
country: Russian Federation
facility: Site: 714
city: Samara
country: Russian Federation
facility: Site: 708
city: Saratov
country: Russian Federation
facility: Site: 709
city: St. Petersburg
country: Russian Federation
facility: Site: 703
city: St. Petersburg
country: Russian Federation
facility: Site: 716
city: St. Petersburg
country: Russian Federation
facility: Site: 704
city: St. Petersburg
country: Russian Federation
facility: Site: 706
city: Tomsk
country: Russian Federation
facility: Site: 713
city: Yaroslavl
country: Russian Federation
facility: Site: 711
city: Valencia
country: Spain
facility: Site: 303
city: Valencia
country: Spain
facility: Site: 304
city: Valladolid
country: Spain
facility: Site: 305
city: Chernihiv
country: Ukraine
facility: Site: 808
city: Kharkiv
country: Ukraine
facility: Site: 803
city: Kvuv
country: Ukraine
facility: Site: 812
city: Kyiv
country: Ukraine
facility: Site: 805
city: Kyiv
country: Ukraine
facility: Site: 807
city: Kyiv
country: Ukraine
facility: Site: 806
city: Lviv
country: Ukraine
facility: Site: 810
city: Mykolayiv
country: Ukraine
facility: Site: 802
city: Odesa
country: Ukraine
facility: Site: 801
city: Vinnitsa
country: Ukraine
facility: Site: 813
city: Zaporizhzhya
country: Ukraine
facility: Site: 815
city: Chorley
country: United Kingdom
facility: Site: 102
city: Liverpool
country: United Kingdom
facility: Site: 103
city: Poole
country: United Kingdom
facility: Site: 104
city: Rugby
country: United Kingdom
facility: Site: 101
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Senior Clinical Study Manager
role: STUDY_DIRECTOR
References:
citation: 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.