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

  Show 64 Study Locations
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
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014