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

November 21, 2011
March 26, 2014
November 2011
February 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01478607 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Painful Diabetic Peripheral Neuropathy (PDPN)
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: 1. Qutenza 30 minutes + SOC
    Intervention: Drug: QUTENZA
  • Experimental: 2. Qutenza 60 minutes + SOC
    Intervention: Drug: QUTENZA
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
468
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   France,   Spain,   Italy,   Germany,   Belgium,   Netherlands,   Russian Federation,   Ukraine,   Czech Republic,   Poland
 
NCT01478607
E05-CL-3002, 2009-016458-42
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Senior Clinical Study Manager Astellas Pharma Europe B.V.
Astellas Pharma Inc
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP