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(s) targeted: Diabetic Peripheral Neuropathy; Pain

Intervention: Capsaicin 8% (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Clinical Study Manager, Study Chair, Affiliation: Astellas Pharma Europe B.V.

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.

Official title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8

Secondary outcome:

Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12

Weekly Percent Change From Baseline in Average Daily Pain Score

Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline

Percentage of Participants With 30% Reduction in Average Daily Pain Score.

Percentage of Participants With 50% Reduction in Average Daily Pain Score.

Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2

Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8

Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12

Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12

Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12

Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.

Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12

Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12

Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.

Change From Pre-application in"Pain Now" Score

Number of Participants Who Used Rescue Pain Medication Days 1 Through 5

Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12

Detailed description: Participants were divided into 2 groups of approximately equal size. In the first group, participants received a Capsaicin 8% patch applied for 30 minutes to the feet; in the second group, participants received a placebo patch applied for 30 minutes to the feet. Participants were involved in the study for approximately 12 weeks and have visited the clinic approximately 6 times.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Site: 125, Anniston, Alabama 36207, United States

Site: 131, Fresno, California 93720, United States

Site: 123, Long Beach, California 90806, United States

Site: 116, Los Angeles, California 90033, United States

Site: 112, Orange, California 92868, United States

Site: 130, Walnut Creek, California 94597, United States

Site: 113, Milford, Connecticut 06460, United States

Site: 119, New London, Connecticut 06320, United States

Site: 117, Boynton Beach, Florida 33435, United States

Site: 124, Bradenton, Florida 34205, United States

Site: 107, Clearwater, Florida 33765, United States

Site: 120, Jupiter, Florida 33458, United States

Site: 108, Orlando, Florida 32806, United States

Site: 132, Oviedo, Florida 32765, United States

Site: 127, St. Petersburg, Florida 33709, United States

Site: 122, Tampa, Florida 33606, United States

Site: 133, Honolulu, Hawaii 96814, United States

Site: 126, New Bedford, Massachusetts 02740, United States

Site: 115, Ann Arbor, Michigan 48104, United States

Site: 128, Hazelwood, Missouri 63042, United States

Site:111, New York, New York 10029, United States

Site: 110, Winston-Salem, North Carolina 27103, United States

Site: 121, Kettering, Ohio 45429, United States

Site:106, Dallas, Texas 75230, United States

Site: 114, Houston, Texas 77098, United States

Site: 118, Houston, Texas 77030, United States

Site: 103, Lubbock, Texas 79410, United States

Site: 102, San Antonio, Texas 78229, United States

Site: 105, San Antonio, Texas 78228, United States

Starting date: February 2012
Last updated: March 3, 2015