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TERMINATEDPhase 2NCT01579279

A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic neuropathic pain. People with diabetes can, over time develop nerve damage throughout the body with symptom...

Lead sponsor: AbbVie (prior sponsor, Abbott)•8 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

AbbVie (prior sponsor, Abbott)

A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Subject is between the ages of 18-75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
•Subject must have a mean average score of greater than 4 on the 24 hour average pain score (0-10 numerical rating scale) prior to the Baseline Visit.
•Subject has been on a medication for diabetic neuropathic pain for the past 3 months.

Exclusion Criteria

•Subject has clinically symptomatic neuropathic pain conditions that cannot be distinguished from Diabetic Neuropathic Pain or interfere with the pain assessments of Diabetic Neuropathic Pain.
•A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with Diabetic Neuropathic Pain assessments or other functions.
•Subject has clinically significant abnormalities in clinical laboratory tests.
•Subject has taken an opioid chronically, excluding tramadol within the last 3 months prior to Screening.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 26, 2013Terms

Trial snapshot

StatusTERMINATED

PhasePHASE2

Enrollment1

Start dateApr 2012

Last updatedSep 26, 2013

Condition

Diabetic Neuropathic Pain

Locations shown

Site Reference ID/Investigator# 62887

Anaheim, California

Site Reference ID/Investigator# 62824

Walnut Creek, California

Site Reference ID/Investigator# 63710

Milford, Connecticut

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 26, 2013Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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