A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
- Registration Number
- NCT00548925
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- Males and females, age 18 to 75
- If female, must be of non-childbearing potential or practicing birth control
- Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy
- Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months
- Must be willing to washout of all analgesic medications prior to entry into the study
- Has other conditions that may cause pain
- Currently receiving analgesic medications for conditions other than diabetic neuropathic pain
- Has a history of certain psychiatric diseases
- Has a history of certain heart or cardiovascular conditions
- Has any clinically significant recent infection, injury, or illness
- Current participation in another clinical study or participation within the past 30 days
- Is incapacitated, bedridden or confined to a wheelchair
- Is pregnant and/or breastfeeding
- Previous participation in this study or any other study with this investigational product.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo - 1 ABT-894 -
- Primary Outcome Measures
Name Time Method Weekly mean of 24-hour average pain score Change from Baseline to final
- Secondary Outcome Measures
Name Time Method Pain improvement from Baseline to the final evaluation 8-week Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain 8-week Global assessments of study drug and pain status 8-week Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS) 8-week
Trial Locations
- Locations (29)
Site Reference ID/Investigator# 6356
🇺🇸Hollywood, Florida, United States
Site Reference ID/Investigator# 6564
🇩🇪Bad Mergentheim, Germany
Site Reference ID/Investigator# 11202
🇩🇪Mainz, Germany
Site Reference ID/Investigator# 11201
🇩🇪Berlin, Germany
Site Reference ID/Investigator# 6234
🇩🇪Duesseldorf, Germany
Site Reference ID/Investigator# 5549
🇮🇹L'Aquila, Italy
Site Reference ID/Investigator# 6617
🇺🇸Walnut Creek, California, United States
Site Reference ID/Investigator# 6609
🇺🇸St. Louis, Missouri, United States
Site Reference ID/Investigator# 7229
🇺🇸New Hyde Park, New York, United States
Site Reference ID/Investigator# 6618
🇺🇸Charlotte, North Carolina, United States
Site Reference ID/Investigator# 6358
🇺🇸Wellington, Florida, United States
Site Reference ID/Investigator# 7911
🇪🇸Sabadell, Barcelona, Spain
Site Reference ID/Investigator# 6575
🇺🇸Allentown, Pennsylvania, United States
Site Reference ID/Investigator# 5554
🇨🇿Olomouc, Czech Republic
Site Reference ID/Investigator# 5553
🇨🇿Zlin, Czech Republic
Site Reference ID/Investigator# 5552
🇨🇿Hradec Kralove, Czech Republic
Site Reference ID/Investigator# 9363
🇫🇷Corbeil Essonnes, France
Site Reference ID/Investigator# 5557
🇫🇷Limoges, France
Site Reference ID/Investigator# 6238
🇫🇷Nevers, France
Site Reference ID/Investigator# 7133
🇬🇧Sheffield, United Kingdom
Site Reference ID/Investigator# 7714
🇩🇪Munich, Germany
Site Reference ID/Investigator# 5558
🇮🇹Perugia, Italy
Site Reference ID/Investigator# 5555
🇬🇧Birmingham, United Kingdom
Site Reference ID/Investigator# 6475
🇪🇸Granada, Spain
Site Reference ID/Investigator# 6614
🇺🇸Spring Valley, California, United States
Site Reference ID/Investigator# 6607
🇺🇸Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 6615
🇺🇸Tampa, Florida, United States
Site Reference ID/Investigator# 8179
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 6616
🇺🇸San Antonio, Texas, United States