A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
NCT ID: NCT00548925
Last Updated: 2013-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2007-11-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
ABT-894
6 mg BID tablets, 8 weeks of treatment
2
placebo
BID tablets, 8 weeks of treatment
Interventions
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ABT-894
6 mg BID tablets, 8 weeks of treatment
placebo
BID tablets, 8 weeks of treatment
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Rachel Duan, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 6614
Spring Valley, California, United States
Site Reference ID/Investigator# 6617
Walnut Creek, California, United States
Site Reference ID/Investigator# 6356
Hollywood, Florida, United States
Site Reference ID/Investigator# 6615
Tampa, Florida, United States
Site Reference ID/Investigator# 6358
Wellington, Florida, 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# 6607
Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 6575
Allentown, Pennsylvania, United States
Site Reference ID/Investigator# 8179
San Antonio, Texas, United States
Site Reference ID/Investigator# 6616
San Antonio, Texas, United States
Site Reference ID/Investigator# 5552
Hradec Králové, , Czechia
Site Reference ID/Investigator# 5554
Olomouc, , Czechia
Site Reference ID/Investigator# 5553
Zlín, , Czechia
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# 6564
Bad Mergentheim, , Germany
Site Reference ID/Investigator# 11201
Berlin, , Germany
Site Reference ID/Investigator# 6234
Düsseldorf, , Germany
Site Reference ID/Investigator# 11202
Mainz, , Germany
Site Reference ID/Investigator# 7714
Munich, , Germany
Site Reference ID/Investigator# 5549
L’Aquila, , Italy
Site Reference ID/Investigator# 5558
Perugia, , Italy
Site Reference ID/Investigator# 6475
Granada, , Spain
Site Reference ID/Investigator# 7911
Sabadell, Barcelona, , Spain
Site Reference ID/Investigator# 5555
Birmingham, , United Kingdom
Site Reference ID/Investigator# 7133
Sheffield, , United Kingdom
Countries
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Other Identifiers
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2007-001140-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M10-014
Identifier Type: -
Identifier Source: org_study_id
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