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

Painful Diabetic Peripheral Neuropathy (PDPN) Clinical Trial

— PACE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478607
• Other study ID #: E05-CL-3002
• Secondary ID: 2009-016458-42
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2011
• Last updated: October 12, 2015
• Start date: November 2011
• Est. completion date: February 2014

Study information

• Verified date: October 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Russia: Ministry of Health of the Russian FederationSpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUkraine: State Pharmacological Center - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Peripheral Neuropathy (PDPN)
• Peripheral Nervous System Diseases

Intervention

Drug:
• QUTENZA
A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).

Locations

Country	Name	City	State
Belgium	Site: 601	Bonheiden
Czech Republic	Site: 903	Beroun
Czech Republic	Site: 910	Brno
Czech Republic	Site: 908	Chocen
Czech Republic	Site: 911	Litomerice
Czech Republic	Site: 906	Ostrava
Czech Republic	Site: 904	Policka
Czech Republic	Site: 901	Praha 4
Czech Republic	Site: 902	Prerov
Czech Republic	Site: 909	Rychnov nad Kneznou
France	Site: 207	Bron
France	Site: 202	Paris
France	Site: 201	Pierre Benite
France	Site: 206	Toulouse
Germany	Site: 508	Chiemsee
Germany	Site: 502	Dresden
Germany	Site: 501	Falkensee
Germany	Site: 514	Frankfurt
Germany	Site: 507	Hamburg
Germany	Site: 509	Koln
Germany	Site: 505	Leipzig
Germany	Site: 506	Muenster
Germany	Site: 512	Wangen
Italy	Site: 404	Milano
Italy	Site: 401	Roma
Netherlands	Site: 651	Utrecht
Poland	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	Warszawa
Russian Federation	Site: 714	Kemerovo
Russian Federation	Site: 708	Samara
Russian Federation	Site: 709	Saratov
Russian Federation	Site: 703	St. Petersburg
Russian Federation	Site: 704	St. Petersburg
Russian Federation	Site: 706	St. Petersburg
Russian Federation	Site: 716	St. Petersburg
Russian Federation	Site: 713	Tomsk
Russian Federation	Site: 711	Yaroslavl
Spain	Site: 303	Valencia
Spain	Site: 304	Valencia
Spain	Site: 305	Valladolid
Ukraine	Site: 808	Chernihiv
Ukraine	Site: 803	Kharkiv
Ukraine	Site: 812	Kvuv
Ukraine	Site: 805	Kyiv
Ukraine	Site: 806	Kyiv
Ukraine	Site: 807	Kyiv
Ukraine	Site: 810	Lviv
Ukraine	Site: 802	Mykolayiv
Ukraine	Site: 801	Odesa
Ukraine	Site: 813	Vinnitsa
Ukraine	Site: 815	Zaporizhzhya
United Kingdom	Site: 102	Chorley
United Kingdom	Site: 103	Liverpool
United Kingdom	Site: 104	Poole
United Kingdom	Site: 101	Rugby

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	Tolerability of patch application by dermal assessment		Screening till Last visit when QUTENZA patch is applied (up to 53 weeks)	No
Secondary	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)	No
Secondary	Tolerability of patch application by rescue medication use		Days 1 through 5 after each patch application	No
Secondary	Adverse Events and serious adverse Events		Screening visit through End of study visit (up to 65 weeks)	Yes
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Brief Pain Inventory (BPI) pain severity index and pain interference index		Screening visit through End of study visit (up to 65 weeks)	No
Secondary	Patient Global Impression of Change		After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks)	No
Secondary	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)	No
Secondary	Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit		End of Study (up to 65 weeks)	No

External Links

•   Link to results on Astellas Clinical Study Results Web site
•   Link to results on EudraCT