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)
STEP
A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy
1 other identifier
interventional
369
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2012
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 12, 2012
CompletedFirst Posted
Study publicly available on registry
February 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
March 13, 2015
CompletedNovember 4, 2015
October 1, 2015
2 years
February 12, 2012
February 6, 2015
October 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Baseline to between Weeks 2 to 8
Secondary Outcomes (17)
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12
Baseline to between Weeks 2 and 12
Weekly Percent Change From Baseline in Average Daily Pain Score
Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12
Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline
Baseline and Weeks 2, 4, 8 and 12
Percentage of Participants With 30% Reduction in Average Daily Pain Score.
Baseline, Weeks 2-8 and Weeks 2-12
Percentage of Participants With 50% Reduction in Average Daily Pain Score.
Baseline, Weeks 2-8 and Weeks 2-12
- +12 more secondary outcomes
Study Arms (2)
Capsaicin 8%
EXPERIMENTALCapsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
Placebo
PLACEBO COMPARATORPlacebo patch was applied for 30 minutes to the painful area(s) on Day 1
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
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: 118
Houston, Texas, 77030, United States
Site: 114
Houston, Texas, 77098, United States
Site: 103
Lubbock, Texas, 79410, United States
Site: 105
San Antonio, Texas, 78228, United States
Site: 102
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 27746370DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Medical Science Director, Global Medical Science
- Organization
- Astellas Pharma Global Development
Study Officials
- STUDY CHAIR
Clinical Study Manager
Astellas Pharma Europe B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2012
First Posted
February 15, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
November 4, 2015
Results First Posted
March 13, 2015
Record last verified: 2015-10