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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetic Neuropathic Pain

In brief

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 symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

Key facts

Study ID

NCT01579279

Run by

AbbVie (prior sponsor, Abbott)

People needed

1

Starts

2012-04-01

Expected to finish

2012-05-01

Last updated by the study team

2013-09-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 62887 — Anaheim, California, United States
• Site Reference ID/Investigator# 62824 — Walnut Creek, California, United States
• Site Reference ID/Investigator# 63710 — Milford, Connecticut, United States
• Site Reference ID/Investigator# 62884 — DeLand, Florida, United States
• Site Reference ID/Investigator# 62826 — Orlando, Florida, United States
• Site Reference ID/Investigator# 63703 — Brockton, Massachusetts, United States
• Site Reference ID/Investigator# 73913 — Olive Branch, Mississippi, United States
• Site Reference ID/Investigator# 62886 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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