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 - ND

• Conditions: diabetic neuropathic pain; MedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

• Registration Number: EUCTR2007-001139-71-IT
• Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

Look at Synopsis Main Inclusion Criteria (1-12)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Look at Synopsis:Main Exclusion Criteria(1-18)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to compare the analgesic efficacy and safety of ABT?894 (1 mg, 2 mg, and 4 mg capsules) administered twice daily (BID), to placebo in the treatment of diabetic neuropathic pain (DNP). Duloxetine 60 mg administered once daily (QD) will be assessed for assay sensitivity.;Secondary Objective: To explore the pharmacokinetic and pharmacogenetic characteristics of ABT-894 in the Diabetic Neuropathic Pain population;Primary end point(s): The primary efficacy measure will be weekly mean of 24-hour Average Pain Score (abbreviated as 24-hour average pain score) measured by the 11-point Likert Scale and calculated from subject's daily diary.