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)
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01579279
First received: April 16, 2012
Last updated: September 24, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 24-hour Average Pain Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measures severity of common neuropathic pain qualities (burning, pressure, squeezing)

  • Patient Global Impression of Change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication

  • Brief Pain Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Capture the subject's severity of pain and interference

  • Neuropathic Pain Impact on Quality of Life Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579279

Locations
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)
Investigators
Study Director: Wolfram Nothaft, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01579279     History of Changes
Other Study ID Numbers: M11-210, 2011-003939-56
Study First Received: April 16, 2012
Last Updated: September 24, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Mexico: Federal Commission for Protection Against Health Risks
Hungary: Ministry of Health, Social and Family Affairs
Romania: National Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Russia: Ministry of Health of the Russian Federation

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

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on October 16, 2014