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A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Painful Diabetic Peripheral Neuropathy (PDPN)

Intervention: QUTENZA (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Senior Clinical Study Manager, Study Director, Affiliation: Astellas Pharma Europe B.V.

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale

Secondary outcome:

Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing

Tolerability of patch application by dermal assessment

Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application

Tolerability of patch application by rescue medication use

Adverse Events and serious adverse Events

Vital Signs (heart rate and blood pressure)

Laboratory Analyses

Intensity of neuropathic pain using "average pain" NPRS scores

Brief Pain Inventory (BPI) pain severity index and pain interference index

Patient Global Impression of Change

Generic HRQOL measured by European Quality of Life - 5 Dimensions (EQ-5D) questionnaire

Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Site: 601, Bonheiden 2820, Belgium

Site: 903, Beroun 26601, Czech Republic

Site: 910, Brno 60200, Czech Republic

Site: 908, Chocen 56501, Czech Republic

Site: 911, Litomerice 41201, Czech Republic

Site: 906, Ostrava 71000, Czech Republic

Site: 904, Policka 57201, Czech Republic

Site: 901, Praha 4 14000, Czech Republic

Site: 902, Prerov 75003, Czech Republic

Site: 909, Rychnov nad Kneznou 51601, Czech Republic

Site: 207, Bron 69677, France

Site: 202, Paris 75004, France

Site: 201, Pierre Benite 69495, France

Site: 206, Toulouse 31059, France

Site: 508, Chiemsee 83209, Germany

Site: 502, Dresden 1307, Germany

Site: 501, Falkensee 14612, Germany

Site: 514, Frankfurt 60311, Germany

Site: 507, Hamburg 22177, Germany

Site: 509, Koln 50937, Germany

Site: 505, Leipzig 04109, Germany

Site: 506, Muenster 48145, Germany

Site: 512, Wangen 88239, Germany

Site: 404, Milano 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, Warszawa 1868, Poland

Site: 714, Kemerovo 150062, Russian Federation

Site: 708, Samara 79117778999, Russian Federation

Site: 709, Saratov 79117120826, Russian Federation

Site: 703, St. Petersburg 191015, Russian Federation

Site: 704, St. Petersburg 79117120826, Russian Federation

Site: 706, St. Petersburg 79117778999, Russian Federation

Site: 716, St. Petersburg 194358, Russian Federation

Site: 713, Tomsk 79117778999, Russian Federation

Site: 711, Yaroslavl 79117778999, Russian Federation

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: 806, Kyiv 4114, Ukraine

Site: 807, Kyiv 4053, 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

Additional Information

Link to results on EudraCT

Starting date: November 2011
Last updated: June 15, 2015

Page last updated: August 20, 2015

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