A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Neuropathic Pain

In brief

The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy

Key facts

Study ID

NCT00548925

Run by

AbbVie (prior sponsor, Abbott)

People needed

124

Starts

2007-11-01

Expected to finish

2008-12-01

Last updated by the study team

2013-01-21

Who can join

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

You may qualify if…

• Males and females, age 18 to 75
• If female, must be of non-childbearing potential or practicing birth control
• Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy
• Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months
• Must be willing to washout of all analgesic medications prior to entry into the study

You may not qualify if…

• Has other conditions that may cause pain
• Currently receiving analgesic medications for conditions other than diabetic neuropathic pain
• Has a history of certain psychiatric diseases
• Has a history of certain heart or cardiovascular conditions
• Has any clinically significant recent infection, injury, or illness
• Current participation in another clinical study or participation within the past 30 days
• Is incapacitated, bedridden or confined to a wheelchair
• Is pregnant and/or breastfeeding
• Previous participation in this study or any other study with this investigational product.

Where it is running

• Site Reference ID/Investigator# 6614 — Spring Valley, California, United States
• Site Reference ID/Investigator# 6617 — Walnut Creek, California, United States
• Site Reference ID/Investigator# 6356 — Hollywood, Florida, United States
• Site Reference ID/Investigator# 6615 — Tampa, Florida, United States
• Site Reference ID/Investigator# 6358 — Wellington, Florida, United States
• Site Reference ID/Investigator# 6609 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 7229 — New Hyde Park, New York, United States
• Site Reference ID/Investigator# 6618 — Charlotte, North Carolina, United States
• Site Reference ID/Investigator# 6607 — Oklahoma City, Oklahoma, United States
• Site Reference ID/Investigator# 6575 — Allentown, Pennsylvania, United States
• Site Reference ID/Investigator# 8179 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 6616 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 5552 — Hradec Králové, Czechia
• Site Reference ID/Investigator# 5554 — Olomouc, Czechia
• Site Reference ID/Investigator# 5553 — Zlín, Czechia
• Site Reference ID/Investigator# 9363 — Corbeil-Essonnes, France
• Site Reference ID/Investigator# 5557 — Limoges, France
• Site Reference ID/Investigator# 6238 — Nevers, France
• Site Reference ID/Investigator# 6564 — Bad Mergentheim, Germany
• Site Reference ID/Investigator# 11201 — Berlin, Germany
• Site Reference ID/Investigator# 6234 — Düsseldorf, Germany
• Site Reference ID/Investigator# 11202 — Mainz, Germany
• Site Reference ID/Investigator# 7714 — Munich, Germany
• Site Reference ID/Investigator# 5549 — L’Aquila, Italy
• Site Reference ID/Investigator# 5558 — Perugia, Italy

Full record on ClinicalTrials.gov

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