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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478607
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Painful Diabetic Peripheral Neuropathy (PDPN) Drug: QUTENZA Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
    Physicians measuring neurological function will be blinded to treatment

  2. Tolerability of patch application by dermal assessment [ Time Frame: Screening till Last visit when QUTENZA patch is applied (up to 53 weeks) ]
  3. 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) ]
    Assessed within 15 minutes and 60 minutes after patch removal.

  4. Tolerability of patch application by rescue medication use [ Time Frame: Days 1 through 5 after each patch application ]
  5. Adverse Events and serious adverse Events [ Time Frame: Screening visit through End of study visit (up to 65 weeks) ]
  6. Vital Signs (heart rate and blood pressure) [ Time Frame: Screening visit through End of study visit (up to 65 weeks) ]
    In case of patch application to be performed within 15 minutes before topical anesthetic application and within 15 minutes after patch removal.

  7. Laboratory Analyses [ Time Frame: Screening visit through End of study visit (up to 65 weeks) ]
    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.

  8. Intensity of neuropathic pain using "average pain" NPRS scores [ Time Frame: Screening visit through End of study visit (up to 65 weeks) ]
    Question 5 of Brief Pain Inventory-Diabetic Neuropathy (BPI-DN)

  9. Brief Pain Inventory (BPI) pain severity index and pain interference index [ Time Frame: Screening visit through End of study visit (up to 65 weeks) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01478607

  Hide Study Locations
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
Site: 207
Bron, France, 69677
Site: 202
Paris, France, 75004
Site: 201
Pierre Benite, France, 69495
Site: 206
Toulouse, France, 31059
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
Site: 404
Milano, Italy, 20162
Site: 401
Roma, Italy, 00133
Site: 651
Utrecht, Netherlands, 3584 CX
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: 716
St. Petersburg, Russian Federation, 194358
Site: 704
St. Petersburg, Russian Federation, 79117120826
Site: 706
St. Petersburg, Russian Federation, 79117778999
Site: 713
Tomsk, Russian Federation, 79117778999
Site: 711
Yaroslavl, Russian Federation, 79117778999
Site: 303
Valencia, Spain, 46010
Site: 304
Valencia, Spain, 46014
Site: 305
Valladolid, Spain, 47012
Site: 808
Chernihiv, Ukraine, 14034
Site: 803
Kharkiv, Ukraine, 61037
Site: 812
Kvuv, Ukraine, 79010
Site: 805
Kyiv, Ukraine, 2091
Site: 807
Kyiv, Ukraine, 4053
Site: 806
Kyiv, Ukraine, 4114
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
Study Director: Senior Clinical Study Manager Astellas Pharma Europe B.V.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc Identifier: NCT01478607     History of Changes
Other Study ID Numbers: E05-CL-3002
2009-016458-42 ( EudraCT Number )
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Astellas Pharma Inc:
Painful Diabetic Peripheral Neuropathy

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