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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain

Brief Summary: 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 Summary:
Sponsor: AbbVie (prior sponsor, Abbott)

Current Primary Outcome: A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary [ Time Frame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study) ]

Daily questions asked on a hand held diary


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient's Global Impression of Change [ Time Frame: Week 2, Week 4 and Week 6 (End of Study) ]
    Paper questionnaire
  • Brief Pain Inventory (BPI) (short form) including Severity and Interference [ Time Frame: At each visit up to Week 6 (end of Study) ]
    Paper questionnaire
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Baseline, Week 2, Week 4 and Week 6 (end of Study) ]
    Paper questionnaire


Original Secondary Outcome: Same as current

Information By: AbbVie

Dates:
Date Received: April 28, 2011
Date Started: April 2011
Date Completion:
Last Updated: January 3, 2013
Last Verified: January 2013