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

This study has been terminated.
(Study Stopped)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: April 16, 2012
Last updated: September 24, 2013
Last verified: August 2013
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.

Condition Intervention Phase
Diabetic Neuropathic Pain
Drug: ABT-652 6 mg
Drug: ABT-652 12 mg
Drug: ABT-652 12 mg - 18 mg
Drug: Placebo
Drug: Duloxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 24-hour Average Pain Score [ Time Frame: 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:
  • Neuropathic Pain Symptom Inventory [ Time Frame: 12 weeks ]
    Measures severity of common neuropathic pain qualities (burning, pressure, squeezing)

  • Patient Global Impression of Change [ Time Frame: 12 weeks ]
    Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication

  • Brief Pain Inventory [ Time Frame: 12 weeks ]
    Capture the subject's severity of pain and interference

  • Neuropathic Pain Impact on Quality of Life Questionnaire [ Time Frame: 12 weeks ]
    Captures the subject's assessment of neuropathic pain and the effect it has on the quality of daily life

  • EuroQuality of Life - 5 Dimension -5 Level [ Time Frame: 12 weeks ]
    Capture's the subject's mobility, self-care, usual activity, pain/discomfort and anxiety/depression

Enrollment: 1
Study Start Date: April 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-652 6 mg
ABT-652 capsules - twice daily
Drug: ABT-652 6 mg
6 mg capsules
Experimental: ABT-652 12 mg
ABT-652 capsules twice daily
Drug: ABT-652 12 mg
12 mg capsules
Experimental: ABT-652 12 mg - 18 mg
ABT-652 capsules twice daily
Drug: ABT-652 12 mg - 18 mg
12 mg - 18 mg capsules
Placebo Comparator: Placebo
Placebo capsules twice daily
Drug: Placebo
Placebo capsules
Active Comparator: Duloxetine
Duloxetine capsules once daily
Drug: Duloxetine
Duloxetine capsules

Detailed Description:
A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01579279

United States, California
Site Reference ID/Investigator# 62887
Anaheim, California, United States, 92801
Site Reference ID/Investigator# 62824
Walnut Creek, California, United States, 94598
United States, Connecticut
Site Reference ID/Investigator# 63710
Milford, Connecticut, United States, 06460
United States, Florida
Site Reference ID/Investigator# 62884
DeLand, Florida, United States, 32720
Site Reference ID/Investigator# 62826
Orlando, Florida, United States, 32806
United States, Massachusetts
Site Reference ID/Investigator# 63703
Brockton, Massachusetts, United States, 02301
United States, Mississippi
Site Reference ID/Investigator# 73913
Olive Branch, Mississippi, United States, 38654
United States, Texas
Site Reference ID/Investigator# 62886
Dallas, Texas, United States, 75231
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Wolfram Nothaft, MD AbbVie
  More Information

Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01579279     History of Changes
Other Study ID Numbers: M11-210
2011-003939-56 ( EudraCT Number )
Study First Received: April 16, 2012
Last Updated: September 24, 2013

Keywords provided by AbbVie:
Diabetic neuropathic pain
Active controlled phase 2 study

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents processed this record on April 26, 2017