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Completed Phase 3 Interventional Results available

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)

ClinicalTrials.gov ID: NCT01533428

Public ClinicalTrials.gov record NCT01533428. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:36 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01533428
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Astellas Pharma Inc
Industry
Enrollment
369 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2012 (Type not available)
Primary completion
Feb 2014 (Actual)
Completion
Feb 2014 (Actual)
Last update posted
Nov 4, 2015

2012 – 2014

United States locations

U.S. sites
29
U.S. states
12
U.S. cities
27
Facility City State ZIP Site status
Site: 125 Anniston Alabama 36207 —
Site: 131 Fresno California 93720 —
Site: 123 Long Beach California 90806 —
Site: 116 Los Angeles California 90033 —
Site: 112 Orange California 92868 —
Site: 130 Walnut Creek California 94597 —
Site: 113 Milford Connecticut 06460 —
Site: 119 New London Connecticut 06320 —
Site: 117 Boynton Beach Florida 33435 —
Site: 124 Bradenton Florida 34205 —
Site: 107 Clearwater Florida 33765 —
Site: 120 Jupiter Florida 33458 —
Site: 108 Orlando Florida 32806 —
Site: 132 Oviedo Florida 32765 —
Site: 127 St. Petersburg Florida 33709 —
Site: 122 Tampa Florida 33606 —
Site: 133 Honolulu Hawaii 96814 —
Site: 126 New Bedford Massachusetts 02740 —
Site: 115 Ann Arbor Michigan 48104 —
Site: 128 Hazelwood Missouri 63042 —
Site:111 New York New York 10029 —
Site: 110 Winston-Salem North Carolina 27103 —
Site: 121 Kettering Ohio 45429 —
Site:106 Dallas Texas 75230 —
Site: 118 Houston Texas 77030 —
Site: 114 Houston Texas 77098 —
Site: 103 Lubbock Texas 79410 —
Site: 105 San Antonio Texas 78228 —
Site: 102 San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01533428, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 4, 2015 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01533428 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →