A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Study Identifier
M10-014
CT.gov Identifier
NCT00548925
EudraCT Identifier
2007-001140-47
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Pain
    • Study Drug
  • ABT-894
  • placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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
    Exclusion Criteria:
    * 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.

    Protocol 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

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 6614
    Spring Valley, California, United States, 91978
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 6617
    Walnut Creek, California, United States, 94598
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 6356
    Hollywood, Florida, United States, 33021
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 6615
    Tampa, Florida, United States, 33603
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 6358
    Wellington, Florida, United States, 33414
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 6609
    St Louis, Missouri, United States, 63141
    Status
    Not applicable
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