Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Phase 2

Completed

Conditions: Diabetic Neuralgia
Diabetic Neuropathies
Diabetic Neuropathy, Painful
Diabetic Polyneuropathy
Neuralgia, Diabetic

Interventions: Drug: ABT-894
Drug: placebo
Drug: Duloxetine

Registration Number: NCT00507936

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary: This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 280

Inclusion Criteria

If female, subject is either postmenopausal for at least two (2) years or surgically sterile or is practicing at least one (1) method of birth control.
If female, subject must have negative results for pregnancy tests.
The subject must have a diagnosis of diabetes mellitus (Type 1 or Type 2) and a diagnosis of DNP.
Subject's DNP must be present for a minimum of six (6) months and should have begun in the feet with relative symmetrical onset.
Subject has an HgbA1c <= 9. Subjects who have an HgbA1c > 9 and <= 11 may be included in the study.
If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method (condom) of birth control for the duration of the study and for 7 days following the last dose of study drug.

Exclusion Criteria

The subject has failed previous treatment with duloxetine for DNP.
Subject has a diagnosis of narrow-angle glaucoma.
Subject has a history of an allergic reaction or intolerance to duloxetine, acetaminophen, or any other NNR agonist.
Subject has a diagnosis of fibromyalgia that requires treatment.
Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
Subject has a history of seizures (febrile may be ok) or major depressive episode within the past two (2) years or major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
Subject has a history of myocardial infarction (MI) within six (6) months of the Screening Visit.
Subject has unstable angina.
Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
Subject has undergone a cardiac revascularization procedure within 30 days of Screening.
Subject has uncontrolled hypertension (HTN) defined as a systolic blood pressure (BP) >= 160 and/or a diastolic blood pressure (BP) >= 100 at Screening and/or Baseline.
Subject has a clinically significant abnormal ECG at Screening
Subject has an active malignancy of any type or has been diagnosed with or treated for cancer within the past 5 years.
Subject has a positive result for drugs of abuse at Screening with the exception of a positive result for a known prescribed medication.
Subject's screening laboratory results show hepatitis A, B or C.
Subject has a known or suspected history of Human Immunodeficiency Virus (HIV).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	ABT-894	ABT-894 1 mg BID
B	ABT-894	ABT-894 2 mg BID
C	ABT-894	ABT-894 4 mg BID
D	placebo	-
E	Duloxetine	Duloxetine 60 mg QD

Primary Outcome Measures

Name	Time	Method
Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP	Change from baseline to final 24-hour average pain score

Secondary Outcome Measures

Name	Time	Method
Proportions of treatment responders; subjects who complete treatment period with 30% improvement	From Baseline to final 24-hour average pain score
Mean of 24-hour worst pain severity, average of night pain, and average of morning pain measured by the 11-point Likert scale and from subject's daily diary	Weekly through treatment phase
Brief Pain Inventory (BPI) (short form) including Pain Severity	At each visit from Baseline to Week 8 visit
Clinician Global Impression: Severity (CGI-S) and Patient Global Impression: Change (PGI-C)	At each visit from Baseline to Week 8 visit

Trial Locations

Locations (49): Site Reference ID/Investigator# 6052
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Anaheim, California, United States
Site Reference ID/Investigator# 5276
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Clearwater, Florida, United States
Site Reference ID/Investigator# 8121
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San Juan, Puerto Rico
Site Reference ID/Investigator# 5947
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Cincinnati, Ohio, United States
Site Reference ID/Investigator# 7699
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Houston, Texas, United States
Site Reference ID/Investigator# 5836
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San Antonio, Texas, United States
Site Reference ID/Investigator# 5899
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San Antonio, Texas, United States
Site Reference ID/Investigator# 5950
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San Antonio, Texas, United States
Site Reference ID/Investigator# 7187
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San Antonio, Texas, United States
Site Reference ID/Investigator# 6053
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Phoenix, Arizona, United States
Site Reference ID/Investigator# 5217
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Portland, Oregon, United States
Site Reference ID/Investigator# 7906
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Omaha, Nebraska, United States
Site Reference ID/Investigator# 5207
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Mesa, Arizona, United States
Site Reference ID/Investigator# 7387
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North Little Rock, Arkansas, United States
Site Reference ID/Investigator# 6043
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St. Louis, Missouri, United States
Site Reference ID/Investigator# 8125
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Monterrey, N.L., Mexico
Site Reference ID/Investigator# 5018
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Milan, Italy
Site Reference ID/Investigator# 7696
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Nanterre, France
Site Reference ID/Investigator# 8286
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National City, California, United States
Site Reference ID/Investigator# 5171
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Nevers, France
Site Reference ID/Investigator# 7514
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Palm Beach Gardens, Florida, United States
Site Reference ID/Investigator# 5216
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New York, New York, United States
Site Reference ID/Investigator# 8436
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Laval, Canada
Site Reference ID/Investigator# 8481
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Winnipeg, Canada
Site Reference ID/Investigator# 6781
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Hialeah, Florida, United States
Site Reference ID/Investigator# 6044
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St. Louis, Missouri, United States
Site Reference ID/Investigator# 6045
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New York, New York, United States
Site Reference ID/Investigator# 5946
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New York, New York, United States
Site Reference ID/Investigator# 8508
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Kingston, Canada
Site Reference ID/Investigator# 7483
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New York, New York, United States
Site Reference ID/Investigator# 5258
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Corbeil Essonnes, France
Site Reference ID/Investigator# 5260
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Narbonne, France
Site Reference ID/Investigator# 6760
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Heidelberg, Germany
Site Reference ID/Investigator# 6763
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Berlin, Germany
Site Reference ID/Investigator# 5034
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Frankfurt, Germany
Site Reference ID/Investigator# 6732
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Mainz, Germany
Site Reference ID/Investigator# 8497
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Mexico D.F., Mexico
Site Reference ID/Investigator# 7117
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Essen, Germany
Site Reference ID/Investigator# 7064
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Garden Grove, California, United States
Site Reference ID/Investigator# 5277
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Brockton, Massachusetts, United States
Site Reference ID/Investigator# 6047
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Pasadena, Maryland, United States
Site Reference ID/Investigator# 6869
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Cuyahoga Falls, Ohio, United States
Site Reference ID/Investigator# 6054
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Seattle, Washington, United States
Site Reference ID/Investigator# 7115
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Nimes, France
Site Reference ID/Investigator# 8427
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Guadalajara, Mexico
Site Reference ID/Investigator# 8120
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Ponce, Puerto Rico
Site Reference ID/Investigator# 5006
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Rome, Italy
Site Reference ID/Investigator# 5206
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Little Rock, Arkansas, United States
Site Reference ID/Investigator# 8113
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Tampa, Florida, United States