A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
Condition: Diabetic Peripheral Neuropathy; Pain
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: Capsaicin 8%; Placebo
Intervention description: Capsaicin 8% transdermal delivery system; Placebo Patch
Intervention MeSH terms: Capsaicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 369.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Painful Diabetic Peripheral Neuropathy,; Capsaicin 8% transdermal delivery system

Summary:

      The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin
      8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused
      by diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to
             diabetes, for at least 1 year 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 (Painful Diabetic Peripheral Neuropathy) in the
             ankles or above

          -  Pain that could not be clearly differentiated from, or conditions that might interfere
             with the assessment of PDPN (Painful Diabetic Peripheral Neuropathy), neurological
             disorders unrelated to diabetic neuropathy (e.g., phantom limb pain from amputation);
             skin condition in the area of the neuropathy that could alter sensation (e.g., plantar
             ulcer)

          -  Current or previous foot ulcer as determined by medical history and medical
             examination

          -  Any amputation of lower extremity

          -  Severe renal disease as defined by a creatinine clearance of <30 ml/min calculated
             according to the Cockcroft-Gault formula

          -  Clinically significant cardiovascular disease within 6 months prior to screening visit
             defined as cerebrovascular accident, unstable or poorly controlled hypertension,
             transient ischemic attack, myocardial infarction, unstable angina, current arrhythmia,
             any heart surgery including coronary artery bypass graft surgery, percutaneous
             coronary angioplasty/stent placement, or valvular heart disease

          -  Significant peripheral vascular disease (intermittent claudication or lack of
             pulsation of either the dorsalis pedis or posterior tibial artery, or ankle-brachial
             systolic blood pressure index of <0.80)

          -  Clinically significant foot deformities, including hallux rigidus, hallux valgus, or
             rigid toe as determined by physical examination as judged by the investigator

          -  Clinically significant ongoing, uncontrolled or untreated abnormalities in cardiac,
             renal, hepatic, or pulmonary function that may interfere either with the ability to
             complete the study or the evaluation of adverse events

          -  Diagnosis of any poorly controlled major psychiatric disorder

          -  Active substance abuse or history of chronic substance abuse within 1 year prior to
             screening visit or any prior chronic substance abuse (including alcoholism) likely to
             re-occur during the study period as judged by the investigator

          -  Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin
             products), any Capsaicin 8% transdermal delivery system excipients, Eutectic Mixture
             of Local Anaesthetics (EMLA) ingredients or adhesives

          -  Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs,
             menthol, methyl salicylate, local anesthetics, steroids or capsaicin products on the
             painful areas within 7 days preceding the first patch application at the baseline
             visit

          -  Use of oral or transdermal opioids exceeding a total daily dose of morphine of 80
             mg/day, or equivalent; or any parenteral opioids, regardless of dose, within 7 days
             preceding the first patch application at the baseline visit

          -  Skin areas to be treated with Capsaicin 8% transdermal delivery system showing changes
             such as crusting or ulcers

          -  Planned elective surgery during the trial