Status:
COMPLETED
A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Painful Diabetic Peripheral Neuropathy (PDPN)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT01478607
Start Date
November 1 2011
End Date
February 1 2014
Last Update
October 14 2015
Active Locations (64)
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1
Site: 601
Bonheiden, Belgium, 2820
2
Site: 903
Beroun, Czechia, 26601
3
Site: 910
Brno, Czechia, 60200
4
Site: 908
Choceň, Czechia, 56501