NCT01579279

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

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Diabetic Neuropathic Pain

Interventions

Type	Name	Description
DRUG	ABT-652 6 mg	6 mg capsules
DRUG	ABT-652 12 mg	12 mg capsules
DRUG	ABT-652 12 mg - 18 mg	12 mg - 18 mg capsules
DRUG	Placebo	Placebo capsules
DRUG	Duloxetine	Duloxetine capsules

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-04-17
• Last updated: 2013-09-26

Locations

8 sites across 1 country: United States