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)

NCT ID: NCT01533428

Last Updated: 2015-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 369 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-02-28

Brief 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.

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.

Conditions

Diabetic Peripheral Neuropathy; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Capsaicin 8%

Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1

Group Type: EXPERIMENTAL

Capsaicin 8%

Intervention Type: DRUG

Capsaicin 8% transdermal delivery system

Placebo

Placebo patch was applied for 30 minutes to the painful area(s) on Day 1

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Patch

Interventions

Capsaicin 8%

Capsaicin 8% transdermal delivery system

Intervention Type: DRUG

Placebo

Placebo Patch

Intervention Type: DRUG

Other Intervention Names

Qutenza

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

Site: 125

Anniston, Alabama, United States

Site: 131

Fresno, California, United States

Site: 123

Long Beach, California, United States

Site: 116

Los Angeles, California, United States

Site: 112

Orange, California, United States

Site: 130

Walnut Creek, California, United States

Site: 113

Milford, Connecticut, United States

Site: 119

New London, Connecticut, United States

Site: 117

Boynton Beach, Florida, United States

Site: 124

Bradenton, Florida, United States

Site: 107

Clearwater, Florida, United States

Site: 120

Jupiter, Florida, United States

Site: 108

Orlando, Florida, United States

Site: 132

Oviedo, Florida, United States

Site: 127

St. Petersburg, Florida, United States

Site: 122

Tampa, Florida, United States

Site: 133

Honolulu, Hawaii, United States

Site: 126

New Bedford, Massachusetts, United States

Site: 115

Ann Arbor, Michigan, United States

Site: 128

Hazelwood, Missouri, United States

Site:111

New York, New York, United States

Site: 110

Winston-Salem, North Carolina, United States

Site: 121

Kettering, Ohio, United States

Site:106

Dallas, Texas, United States

Site: 118

Houston, Texas, United States

Site: 114

Houston, Texas, United States

Site: 103

Lubbock, Texas, United States

Site: 105

San Antonio, Texas, United States

Site: 102

San Antonio, Texas, United States

Countries

United States

References

Simpson DM, Robinson-Papp J, Van J, Stoker M, Jacobs H, Snijder RJ, Schregardus DS, Long SK, Lambourg B, Katz N. Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study. J Pain. 2017 Jan;18(1):42-53. doi: 10.1016/j.jpain.2016.09.008. Epub 2016 Oct 13.

Reference Type: DERIVED

PMID: 27746370 (View on PubMed)

Related Links

https://www.astellasclinicalstudyresults.com/study.aspx?ID=E05-CL-3004

Link to results on Astellas Clinical Study Results Web site

Other Identifiers

E05-CL-3004

Identifier Type: -

Identifier Source: org_study_id