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)
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.
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
- Enrollment
- 369 participants
Conditions and interventions
Conditions
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
- Jan 31, 2012
- Primary completion
- Jan 31, 2014
- Completion
- Jan 31, 2014
- Last update posted
- Nov 3, 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 3, 2015 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01533428 live on ClinicalTrials.gov.