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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01478607
First received: November 21, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Painful Diabetic Peripheral Neuropathy (PDPN)
Drug: QUTENZA
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale [ Time Frame: Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing [ Time Frame: Baseline till End of Study (up to 64 weeks) ] [ Designated as safety issue: No ]
    Physicians measuring neurological function will be blinded to treatment

  • Tolerability of patch application by dermal assessment [ Time Frame: Screening till Last visit when QUTENZA patch is applied (up to 53 weeks) ] [ Designated as safety issue: No ]
  • Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application [ Time Frame: Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks) ] [ Designated as safety issue: No ]
    Assessed within 15 minutes and 60 minutes after patch removal.

  • Tolerability of patch application by rescue medication use [ Time Frame: Days 1 through 5 after each patch application ] [ Designated as safety issue: No ]
  • Adverse Events and serious adverse Events [ Time Frame: Screening visit through End of study visit (up to 65 weeks) ] [ Designated as safety issue: Yes ]
  • Vital Signs (heart rate and blood pressure) [ Time Frame: Screening visit through End of study visit (up to 65 weeks) ] [ Designated as safety issue: No ]
    In case of patch application to be performed within 15 minutes before topical anesthetic application and within 15 minutes after patch removal.

  • Laboratory Analyses [ Time Frame: Screening visit through End of study visit (up to 65 weeks) ] [ Designated as safety issue: No ]
    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.

  • Intensity of neuropathic pain using "average pain" NPRS scores [ Time Frame: Screening visit through End of study visit (up to 65 weeks) ] [ Designated as safety issue: No ]
    Question 5 of Brief Pain Inventory-Diabetic Neuropathy (BPI-DN)

  • Brief Pain Inventory (BPI) pain severity index and pain interference index [ Time Frame: Screening visit through End of study visit (up to 65 weeks) ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks) ] [ Designated as safety issue: No ]
  • Generic HRQOL measured by European Quality of Life - 5 Dimensions (EQ-5D) questionnaire [ Time Frame: After each patch application, from first patch application through End of Study (up to 64 weeks) ] [ Designated as safety issue: No ]
  • Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit [ Time Frame: End of Study (up to 65 weeks) ] [ Designated as safety issue: No ]

Enrollment: 468
Study Start Date: November 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Qutenza 30 minutes + SOC Drug: QUTENZA
A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).
Other Name: Capsaisin
Experimental: 2. Qutenza 60 minutes + SOC Drug: QUTENZA
A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).
Other Name: Capsaisin
No Intervention: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478607

  Hide Study Locations
Locations
Belgium
Site: 601
Bonheiden, Belgium, 2820
Czech Republic
Site: 903
Beroun, Czech Republic, 26601
Site: 910
Brno, Czech Republic, 60200
Site: 908
Chocen, Czech Republic, 56501
Site: 911
Litomerice, Czech Republic, 41201
Site: 906
Ostrava, Czech Republic, 71000
Site: 904
Policka, Czech Republic, 57201
Site: 901
Praha 4, Czech Republic, 14000
Site: 902
Prerov, Czech Republic, 75003
Site: 909
Rychnov nad Kneznou, Czech Republic, 51601
France
Site: 207
Bron, France, 69677
Site: 202
Paris, France, 75004
Site: 201
Pierre Benite, France, 69495
Site: 206
Toulouse, France, 31059
Germany
Site: 508
Chiemsee, Germany, 83209
Site: 502
Dresden, Germany, 1307
Site: 501
Falkensee, Germany, 14612
Site: 514
Frankfurt, Germany, 60311
Site: 507
Hamburg, Germany, 22177
Site: 509
Koln, Germany, 50937
Site: 505
Leipzig, Germany, 04109
Site: 506
Muenster, Germany, 48145
Site: 512
Wangen, Germany, 88239
Italy
Site: 404
Milano, Italy, 20162
Site: 401
Roma, Italy, 00133
Netherlands
Site: 651
Utrecht, Netherlands, 3584 CX
Poland
Site: 965
Bialystok, Poland, 15435
Site: 961
Bydgoszcz, Poland, 85822
Site: 957
Elblag, Poland, 82300
Site: 958
Gdynia, Poland, 81049
Site: 954
Katowice, Poland, 40954
Site: 964
Krakow, Poland, 31530
Site: 951
Lodz, Poland, 90153
Site: 966
Lubin, Poland, 59300
Site: 953
Poznan, Poland, 61655
Site: 959
Torun, Poland, 87100
Site: 960
Warszawa, Poland, 1868
Russian Federation
Site: 714
Kemerovo, Russian Federation, 150062
Site: 708
Samara, Russian Federation, 79117778999
Site: 709
Saratov, Russian Federation, 79117120826
Site: 703
St. Petersburg, Russian Federation, 191015
Site: 704
St. Petersburg, Russian Federation, 79117120826
Site: 706
St. Petersburg, Russian Federation, 79117778999
Site: 716
St. Petersburg, Russian Federation, 194358
Site: 713
Tomsk, Russian Federation, 79117778999
Site: 711
Yaroslavl, Russian Federation, 79117778999
Spain
Site: 303
Valencia, Spain, 46010
Site: 304
Valencia, Spain, 46014
Site: 305
Valladolid, Spain, 47012
Ukraine
Site: 808
Chernihiv, Ukraine, 14034
Site: 803
Kharkiv, Ukraine, 61037
Site: 812
Kvuv, Ukraine, 79010
Site: 805
Kyiv, Ukraine, 2091
Site: 806
Kyiv, Ukraine, 4114
Site: 807
Kyiv, Ukraine, 4053
Site: 810
Lviv, Ukraine, 79010
Site: 802
Mykolayiv, Ukraine, 54003
Site: 801
Odesa, Ukraine, 65009
Site: 813
Vinnitsa, Ukraine, 21010
Site: 815
Zaporizhzhya, Ukraine, 69001
United Kingdom
Site: 102
Chorley, United Kingdom, PR7 1PP
Site: 103
Liverpool, United Kingdom, L7 8XP
Site: 104
Poole, United Kingdom, BH15 2JB
Site: 101
Rugby, United Kingdom, CV22 5PX
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Senior Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01478607     History of Changes
Other Study ID Numbers: E05-CL-3002, 2009-016458-42
Study First Received: November 21, 2011
Last Updated: March 26, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: State Pharmacological Center - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Astellas Pharma Inc:
Painful Diabetic Peripheral Neuropathy
Qutenza

Additional relevant MeSH terms:
Pain
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014