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Completed Phase 2 Interventional Results available

Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

ClinicalTrials.gov ID: NCT01496365

Public ClinicalTrials.gov record NCT01496365. 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 19, 2026, 3:39 AM 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 Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Brief summary

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

The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.

Study identification

NCT ID
NCT01496365
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
452 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
Nov 28, 2011 (Actual)
Primary completion
Sep 7, 2012 (Actual)
Completion
Sep 7, 2012 (Actual)
Last update posted
Jan 5, 2021

2011 – 2012

United States locations

U.S. sites
78
U.S. states
27
U.S. cities
69
Facility City State ZIP Site status
Not listed Birmingham Alabama 35242 —
Not listed Huntsville Alabama 35801 —
Not listed Mesa Arizona 85206 —
Not listed Phoenix Arizona 85023 —
Not listed Phoenix Arizona 85028 —
Not listed Tucson Arizona 85712 —
Not listed Hot Springs Arkansas 71913 —
Not listed Little Rock Arkansas 72205 —
Not listed Buena Park California 90620 —
Not listed Burbank California 91505 —
Not listed Chino California 91710 —
Not listed Fresno California 93726 —
Not listed Huntington Beach California 92648 —
Not listed Lakewood California 90712 —
Not listed Lomita California 90717 —
Not listed Long Beach California 90806 —
Not listed Santa Monica California 90404 —
Not listed Walnut Creek California 94598 —
Not listed Boulder Colorado 80304 —
Not listed Colorado Springs Colorado 80920 —
Not listed Denver Colorado 80209 —
Not listed Golden Colorado 80401 —
Not listed Cromwell Connecticut 06416 —
Not listed Fairfield Connecticut 06824 —
Not listed Bradenton Florida 34208 —
Not listed Brooksville Florida 34601 —
Not listed Clearwater Florida 33756 —
Not listed Hallandale Florida 33009 —
Not listed Miami Florida 33143 —
Not listed Miami Florida 33169 —
Not listed New Port Richey Florida 34217 —
Not listed New Port Richey Florida 34652 —
Not listed Orlando Florida 32806 —
Not listed Sunrise Florida 33351 —
Not listed Columbus Georgia 31909 —
Not listed Gainesville Georgia 30501 —
Not listed Marietta Georgia 30060 —
Not listed Evansville Indiana 44714 —
Not listed Madisonville Kentucky 42431 —
Not listed Paducah Kentucky 42003 —
Not listed Hyattsville Maryland 20782 —
Not listed Brockton Massachusetts 02301 —
Not listed Farmington Hills Michigan 48025 —
Not listed Olive Branch Mississippi 38654 —
Not listed Florissant Missouri 63031 —
Not listed Kansas City Missouri 64114 —
Not listed St Louis Missouri 63141 —
Not listed Omaha Nebraska 68131 —
Not listed Las Vegas Nevada 89106 —
Not listed Las Vegas Nevada 89119 —
Not listed Las Vegas Nevada 89123 —
Not listed Albany New York 12205 —
Not listed Cincinnati Ohio 45245 —
Not listed Dayton Ohio 45439 —
Not listed Toledo Ohio 43623 —
Not listed Tulsa Oklahoma 74104 —
Not listed Duncansville Pennsylvania 16635 —
Not listed Greensburg Pennsylvania 15601 —
Not listed Warwick Rhode Island 02886 —
Not listed Charleston South Carolina 29407 —
Not listed Greer South Carolina 29561 —
Not listed Greer South Carolina 29651 —
Not listed Mt. Pleasant South Carolina 29464 —
Not listed Chattanooga Tennessee 37411 —
Not listed Austin Texas 78731 —
Not listed Dallas Texas 75230 —
Not listed Dallas Texas 75231 —
Not listed El Paso Texas 79925 —
Not listed Houston Texas 77030 —
Not listed San Antonio Texas 78154 —
Not listed San Antonio Texas 78229 —
Not listed Sugar Land Texas 77478 —
Not listed Norfolk Virginia 23507 —
Not listed Norfolk Virginia 23510 —
Not listed Richmond Virginia 23249 —
Not listed Virginia Beach Virginia 23454 —
Not listed Renton Washington 98057 —
Not listed Spokane Washington 99207 —

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 NCT01496365, 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 Jan 5, 2021 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01496365 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →