A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain
NCT ID: NCT01345045
Last Updated: 2013-01-08
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
193 participants
INTERVENTIONAL
2011-04-30
2011-10-31
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
TRIPLE
Study Groups
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ABT-639
ABT-639 twice daily for 6 weeks
ABT-639
ABT-639 Twice Daily for six weeks.
pregabalin
pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study
pregabalin
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
Placebo
Placebo twice daily for 6 weeks
Placebo
Placebo twice daily for 6 weeks.
Interventions
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ABT-639
ABT-639 Twice Daily for six weeks.
pregabalin
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
Placebo
Placebo twice daily for 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.
Exclusion Criteria
* A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
* Subject has clinically significant abnormalities in clinical laboratory tests.
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# 51807
Little Rock, Arkansas, United States
Site Reference ID/Investigator# 51946
Anaheim, California, United States
Site Reference ID/Investigator# 51468
Long Beach, California, United States
Site Reference ID/Investigator# 52744
Walnut Creek, California, United States
Site Reference ID/Investigator# 51079
Clearwater, Florida, United States
Site Reference ID/Investigator# 51076
Hialeah, Florida, United States
Site Reference ID/Investigator# 51945
Hollywood, Florida, United States
Site Reference ID/Investigator# 51077
Ocala, Florida, United States
Site Reference ID/Investigator# 51078
Orlando, Florida, United States
Site Reference ID/Investigator# 51804
Brockton, Massachusetts, United States
Site Reference ID/Investigator# 51263
St Louis, Missouri, United States
Site Reference ID/Investigator# 51268
St Louis, Missouri, United States
Site Reference ID/Investigator# 51302
Omaha, Nebraska, United States
Site Reference ID/Investigator# 51271
Flushing, New York, United States
Site Reference ID/Investigator# 52743
Portland, Oregon, United States
Site Reference ID/Investigator# 51806
Altoona, Pennsylvania, United States
Site Reference ID/Investigator# 51265
Tipton, Pennsylvania, United States
Site Reference ID/Investigator# 51548
Dallas, Texas, United States
Site Reference ID/Investigator# 51269
Renton, Washington, United States
Site Reference ID/Investigator# 51425
Hradec Králové, , Czechia
Site Reference ID/Investigator# 51426
Mor Ostrava, , Czechia
Site Reference ID/Investigator# 51424
Olomouc, , Czechia
Site Reference ID/Investigator# 51428
Prague, , Czechia
Site Reference ID/Investigator# 51423
Prague, , Czechia
Site Reference ID/Investigator# 51427
Zlín, , Czechia
Site Reference ID/Investigator# 51924
Le Creusot, , France
Site Reference ID/Investigator# 51925
Vénissieux, , France
Site Reference ID/Investigator# 51503
Berlin, , Germany
Site Reference ID/Investigator# 51642
Düsseldorf, , Germany
Site Reference ID/Investigator# 51502
Mainz, , Germany
Site Reference ID/Investigator# 52346
Münster, , Germany
Site Reference ID/Investigator# 51505
Guadalajara, Jal., , Mexico
Site Reference ID/Investigator# 51504
Mexico City, , Mexico
Site Reference ID/Investigator# 51522
Monterrey, N.L., , Mexico
Site Reference ID/Investigator# 51506
Monterrey, N.L., , Mexico
Countries
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References
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Ziegler D, Duan WR, An G, Thomas JW, Nothaft W. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015 Oct;156(10):2013-2020. doi: 10.1097/j.pain.0000000000000263.
Other Identifiers
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2010-024359-99
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M11-891
Identifier Type: -
Identifier Source: org_study_id
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