NCT00507936

Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

A Global, Multicenter, Randomized, Double-Blind Placebo Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects With Diabetic Neuropathic Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.

Conditions

• Diabetic Neuralgia
• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Diabetic Polyneuropathy
• Neuralgia, Diabetic

Interventions

Type	Name	Description
DRUG	ABT-894	ABT-894 1 mg capsule BID throughout treatment period
DRUG	ABT-894	ABT-894 2 mg capsule BID throughout treatment period
DRUG	ABT-894	ABT-894 4 mg capsule BID throughout treatment period
DRUG	placebo	placebo capsule BID throughout the treatment period
DRUG	Duloxetine	Duloxetine 60 mg QD throughout treatment period

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-07-27
• Last updated: 2013-01-23

Locations

49 sites across 7 countries: United States, Canada, France, Germany, Italy, Mexico, Puerto Rico