A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Neuropathic Pain

In brief

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

NCT01345045

Run by

AbbVie (prior sponsor, Abbott)

People needed

193

Starts

2011-04-01

Expected to finish

2011-10-01

Last updated by the study team

2013-01-08

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 to 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 an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

You may not qualify if…

• Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
• A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
• Subject has clinically significant abnormalities in clinical laboratory tests.

Where it is running

• Site Reference ID/Investigator# 51807 — Little Rock, Arkansas, United States
• Site Reference ID/Investigator# 51946 — Anaheim, California, United States
• Site Reference ID/Investigator# 51468 — Long Beach, California, United States
• Site Reference ID/Investigator# 52744 — Walnut Creek, California, United States
• Site Reference ID/Investigator# 51079 — Clearwater, Florida, United States
• Site Reference ID/Investigator# 51076 — Hialeah, Florida, United States
• Site Reference ID/Investigator# 51945 — Hollywood, Florida, United States
• Site Reference ID/Investigator# 51077 — Ocala, Florida, United States
• Site Reference ID/Investigator# 51078 — Orlando, Florida, United States
• Site Reference ID/Investigator# 51804 — Brockton, Massachusetts, United States
• Site Reference ID/Investigator# 51263 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 51268 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 51302 — Omaha, Nebraska, United States
• Site Reference ID/Investigator# 51271 — Flushing, New York, United States
• Site Reference ID/Investigator# 52743 — Portland, Oregon, United States
• Site Reference ID/Investigator# 51806 — Altoona, Pennsylvania, United States
• Site Reference ID/Investigator# 51265 — Tipton, Pennsylvania, United States
• Site Reference ID/Investigator# 51548 — Dallas, Texas, United States
• Site Reference ID/Investigator# 51269 — Renton, Washington, United States
• Site Reference ID/Investigator# 51425 — Hradec Králové, Czechia
• Site Reference ID/Investigator# 51426 — Mor Ostrava, Czechia
• Site Reference ID/Investigator# 51424 — Olomouc, Czechia
• Site Reference ID/Investigator# 51428 — Prague, Czechia
• Site Reference ID/Investigator# 51423 — Prague, Czechia
• Site Reference ID/Investigator# 51427 — Zlín, Czechia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.