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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)

NCT01533428 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2015-11-04

Study results available
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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.

Conditions

  • Diabetic Peripheral Neuropathy
  • Pain

Interventions

DRUG

Capsaicin 8%

Capsaicin 8% transdermal delivery system

DRUG

Placebo

Placebo Patch

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Clinical Study Manager · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01533428 on ClinicalTrials.gov