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

Astellas

Status and phase: Completed; Phase 3

Conditions: Painful Diabetic Peripheral Neuropathy (PDPN)

Treatments: Drug: QUTENZA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01478607

E05-CL-3002

2009-016458-42 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 468 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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468 participants in 3 patient groups

1. Qutenza 30 minutes + SOC

Experimental group

Treatment:

Drug: QUTENZA

2. Qutenza 60 minutes + SOC

Experimental group

Treatment:

Drug: QUTENZA

3. SOC

No Intervention group

Description:

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.