Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Study Identifier
M06-850
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Pain
  • Study Drug
  • ABT-894
  • placebo
  • Duloxetine
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years

    Protocol Summary

    This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 5207
    Mesa, Arizona, United States, 85210
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 6053
    Phoenix, Arizona, United States, 85023
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 5206
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 7387
    North Little Rock, Arkansas, United States, 72114
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 6052
    Anaheim, California, United States, 92801
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 7064
    Garden Grove, California, United States, 92845
    Status
    Not applicable
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