A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

Study Identifier
M11-210
CT.gov Identifier
NCT01579279
EudraCT Identifier
2011-003939-56
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Pain
    • Study Drug
  • ABT-652 6 mg
  • ABT-652 12 mg
  • ABT-652 12 mg - 18 mg
  • Placebo
  • Duloxetine
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subject is between the ages of 18-75 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 a mean average score of greater than 4 on the 24 hour average pain score (0-10 numerical rating scale) prior to the Baseline Visit. * Subject has been on a medication for diabetic neuropathic pain for the past 3 months.
    Exclusion Criteria:
    * Subject has clinically symptomatic neuropathic pain conditions that cannot be distinguished from Diabetic Neuropathic Pain or interfere with the pain assessments of Diabetic Neuropathic Pain. * A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with Diabetic Neuropathic Pain assessments or other functions. * Subject has clinically significant abnormalities in clinical laboratory tests. * Subject has taken an opioid chronically, excluding tramadol within the last 3 months prior to Screening.

    Protocol Summary

    To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic neuropathic pain. 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# 62887
    Anaheim, California, United States, 92801
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 62824
    Walnut Creek, California, United States, 94598
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 63710
    Milford, Connecticut, United States, 06460
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 62884
    DeLand, Florida, United States, 32720
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 62826
    Orlando, Florida, United States, 32806
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 63703
    Brockton, Massachusetts, United States, 02301
    Status
    Not applicable
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