A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

Study Identifier
M11-891
CT.gov Identifier
NCT01345045
EudraCT Identifier
2010-024359-99
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-639
  • pregabalin
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. * 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:
    * Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP. * 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.

    Protocol Summary

    People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 51807
    Little Rock, Arkansas, United States, 72204
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51946
    Anaheim, California, United States, 92801
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51468
    Long Beach, California, United States, 90806
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 52744
    Walnut Creek, California, United States, 94598
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51079
    Clearwater, Florida, United States, 33765
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51076
    Hialeah, Florida, United States, 33012
    Status
    Not applicable
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