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

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 comparator 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:

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Abbott:

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 See arm description for more information Other Name: ABT-652
Experimental: ABT-652 12 mg ABT-652 capsules twice daily	Drug: ABT-652 12 mg See arm description for more information Other Name: ABT-652
Experimental: ABT-652 12 mg - 18 mg ABT-652 capsules twice daily	Drug: ABT-652 12 mg - 18 mg See arm description for more information Other Name: ABT-652
Placebo Comparator: Placebo Placebo capsules twice daily	Drug: Placebo comparator See arm description for more information Other Name: Placebo
Active Comparator: Duloxetine Duloxetine capsules once daily	Drug: Duloxetine See arm description for more information Other Name: Duloxetine

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

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

Abbott

Investigators

Study Director:

Wolfram Nothaft, MD

Abbott

More Information

No publications provided

Responsible Party:	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:	July 12, 2012
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 Abbott:

Active controlled phase 2 study
Diabetic neuropathic pain

Additional relevant MeSH terms:

Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013