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Completed Phase 2 Interventional Results available

Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

ClinicalTrials.gov ID: NCT00603265

Public ClinicalTrials.gov record NCT00603265. 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 24, 2026, 9:23 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 2a, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study to Assess the Safety and Efficacy of ADL5859 100 mg BID in Subjects With 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 effectiveness of ADL5859 in relieving the pain associated with diabetic peripheral neuropathy (DPN) compared with placebo and duloxetine (a marketed drug approved for the treatment of painful DPN). The pain symptoms of DPN are thought to be due to damage to nerves caused by the diabetes.

Study identification

NCT ID
NCT00603265
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
226 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
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 2007 (Type not available)
Primary completion
Aug 2008 (Actual)
Completion
Aug 2008 (Actual)
Last update posted
Jul 1, 2015

2007 – 2008

United States locations

U.S. sites
27
U.S. states
14
U.S. cities
24
Facility City State ZIP Site status
Integrated Research Group Riverside California 92506 —
Torrance Clinical Research Torrance California 90505 —
FPA Clinical Research Kissimmee Florida 34741 —
Innovative Research of West Florida, Inc. Largo Florida 33770 —
Panhandle Family Care Associates & Emerald Coast Research Grp, Inc. Marianna Florida 32446 —
Renstar Medical Research Ocala Florida 34471 —
Radiant Research-St.Petersburg Pinellas Park Florida 33781 —
Doctor's Research Network South Miami Florida 33143 —
Metabolic Research Institute, Inc. West Palm Beach Florida 33401 —
Laszlo J. Mate, MD West Palm Beach Florida 33407 —
The Pain Treatment Center of the Bluegrass Lexington Kentucky 40503 —
Beacon Clinical Research Brockton Massachusetts 02301 —
Healthcare Research Florissant Missouri 63031 —
Creighton Diabetes Center, Creighton Univ. Sch. of Medicine Omaha Nebraska 68131 —
Advanced Biomedical Research of America Las Vegas Nevada 89123 —
Clnical Study Center of Asheville Asheville North Carolina 28801 —
Radiant Research-Akron Mogadore Ohio 44260 —
Neurology & Neuroscience Center of Ohio Toledo Ohio 43623 —
Aquilo Research Yukon Oklahoma 73099 —
Clinical Research Consultants, Research Department Medford Oregon 97504 —
Advanced Regional Center for Clinical Research (Ankle & Foot Care) Altoona Pennsylvania 16602 —
Altoona Center for Clinical Research Duncansville Pennsylvania 16635 —
Nerve & Muscle Center of Texas Houston Texas 77030 —
Invisions Consultants LLC San Antonio Texas 78217 —
Diabetes & Glandular Disease Research Associates San Antonio Texas 78229 —
S.A.M. Clinical Research Center San Antonio Texas 78229 —
Tidewater Integrated Medical Research Virginia Beach Virginia 23451 —

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 NCT00603265, 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 Jul 1, 2015 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00603265 live on ClinicalTrials.gov.

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