A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain
- Conditions
- Diabetic Neuropathic Pain
- Interventions
- Registration Number
- NCT01579279
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief 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.
- Detailed Description
A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABT-652 6 mg ABT-652 6 mg ABT-652 capsules - twice daily ABT-652 12 mg ABT-652 12 mg ABT-652 capsules twice daily ABT-652 12 mg - 18 mg ABT-652 12 mg - 18 mg ABT-652 capsules twice daily Placebo Placebo Placebo capsules twice daily Duloxetine Duloxetine Duloxetine capsules once daily
- Primary Outcome Measures
Name Time Method 24-hour Average Pain Score 12 weeks Weekly mean of 24-hour average pain score measured by a 11-point Numeric Rating Scale completed on subject's daily diary.
- Secondary Outcome Measures
Name Time Method Neuropathic Pain Symptom Inventory 12 weeks Measures severity of common neuropathic pain qualities (burning, pressure, squeezing)
Brief Pain Inventory 12 weeks Capture the subject's severity of pain and interference
Neuropathic Pain Impact on Quality of Life Questionnaire 12 weeks Captures the subject's assessment of neuropathic pain and the effect it has on the quality of daily life
Patient Global Impression of Change 12 weeks Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication
EuroQuality of Life - 5 Dimension -5 Level 12 weeks Capture's the subject's mobility, self-care, usual activity, pain/discomfort and anxiety/depression
Trial Locations
- Locations (8)
Site Reference ID/Investigator# 63710
🇺🇸Milford, Connecticut, United States
Site Reference ID/Investigator# 62887
🇺🇸Anaheim, California, United States
Site Reference ID/Investigator# 62884
🇺🇸DeLand, Florida, United States
Site Reference ID/Investigator# 62826
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 62824
🇺🇸Walnut Creek, California, United States
Site Reference ID/Investigator# 73913
🇺🇸Olive Branch, Mississippi, United States
Site Reference ID/Investigator# 62886
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 63703
🇺🇸Brockton, Massachusetts, United States