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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 Jun 26, 2026, 10:55 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

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

Interventions

  • DS-5565 tablet Drug
  • pregabalin capsule Drug
  • Placebo tablet Drug
  • placebo capsule Drug

Drug

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 27, 2011
Primary completion
Sep 6, 2012
Completion
Sep 6, 2012
Last update posted
Jan 4, 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 4, 2021 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01496365 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →