Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

NCT00507936 | Completed Phase 2

• 2 other identifiers: M06-8502007-001139-71
• Study Type: interventional
• Target: 280
• Locations: 7 countries
• Sites: 49

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.

Conditions

Diabetic Neuralgia; Diabetic Neuropathies; Diabetic Neuropathy, Painful; Diabetic Polyneuropathy; Neuralgia, Diabetic

Keywords

Diabetic Neuropathy; Painful; Diabetic Polyneuropathy; Neuralgia; Diabetic; Diabetic Neuropathies; Diabetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (5)

A

EXPERIMENTAL

ABT-894 1 mg BID

Drug: ABT-894

B

EXPERIMENTAL

ABT-894 2 mg BID

Drug: ABT-894

C

EXPERIMENTAL

ABT-894 4 mg BID

Drug: ABT-894

D

PLACEBO COMPARATOR

Drug: placebo

E

ACTIVE COMPARATOR

Duloxetine 60 mg QD

Drug: Duloxetine

Interventions

ABT-894 DRUG

ABT-894 1 mg capsule BID throughout treatment period

A

placebo DRUG

placebo capsule BID throughout the treatment period

D

Duloxetine DRUG

Duloxetine 60 mg QD throughout treatment period

E

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (49)

Site Reference ID/Investigator# 5207

Mesa, Arizona, 85210, United States

Location

Site Reference ID/Investigator# 6053

Phoenix, Arizona, 85023, United States

Location

Site Reference ID/Investigator# 5206

Little Rock, Arkansas, 72205, United States

Location

Site Reference ID/Investigator# 7387

North Little Rock, Arkansas, 72114, United States

Location

Site Reference ID/Investigator# 6052

Anaheim, California, 92801, United States

Location

Site Reference ID/Investigator# 7064

Garden Grove, California, 92845, United States

Location

Site Reference ID/Investigator# 8286

National City, California, 91950, United States

Location

Site Reference ID/Investigator# 5276

Clearwater, Florida, 33765, United States

Location

Site Reference ID/Investigator# 6781

Hialeah, Florida, 33012, United States

Location

Site Reference ID/Investigator# 7514

Palm Beach Gardens, Florida, 33418, United States

Location

Site Reference ID/Investigator# 8113

Tampa, Florida, 33603, United States

Location

Site Reference ID/Investigator# 6047

Pasadena, Maryland, 21122, United States

Location

Site Reference ID/Investigator# 5277

Brockton, Massachusetts, 02301, United States

Location

Site Reference ID/Investigator# 6043

St Louis, Missouri, 63117, United States

Location

Site Reference ID/Investigator# 6044

St Louis, Missouri, 63141, United States

Location

Site Reference ID/Investigator# 7906

Omaha, Nebraska, 68131, United States

Location

Site Reference ID/Investigator# 6045

New York, New York, 10003, United States

Location

Site Reference ID/Investigator# 5946

New York, New York, 10022, United States

Location

Site Reference ID/Investigator# 5216

New York, New York, 10065, United States

Location

Site Reference ID/Investigator# 7483

New York, New York, 10128, United States

Location

Site Reference ID/Investigator# 5947

Cincinnati, Ohio, 45245, United States

Location

Site Reference ID/Investigator# 6869

Cuyahoga Falls, Ohio, 44223, United States

Location

Site Reference ID/Investigator# 5217

Portland, Oregon, 97239, United States

Location

Site Reference ID/Investigator# 7699

Houston, Texas, 77074, United States

Location

Site Reference ID/Investigator# 5836

San Antonio, Texas, 78218, United States

Location

Site Reference ID/Investigator# 5899

San Antonio, Texas, 78229-4801, United States

Location

Site Reference ID/Investigator# 5950

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 7187

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 6054

Seattle, Washington, 98104, United States

Location

Site Reference ID/Investigator# 8508

Kingston, K7L 1G1, Canada

Location

Site Reference ID/Investigator# 8436

Laval, H7T 2P5, Canada

Location

Site Reference ID/Investigator# 8481

Winnipeg, R2V 4W3, Canada

Location

Site Reference ID/Investigator# 5258

Corbeil-Essonnes, 91106, France

Location

Site Reference ID/Investigator# 7696

Nanterre, 92104, France

Location

Site Reference ID/Investigator# 5260

Narbonne, 11108, France

Location

Site Reference ID/Investigator# 5171

Nevers, 58033, France

Location

Site Reference ID/Investigator# 7115

Nîmes, 30029, France

Location

Site Reference ID/Investigator# 6763

Berlin, 10115, Germany

Location

Site Reference ID/Investigator# 7117

Essen, 45138, Germany

Location

Site Reference ID/Investigator# 5034

Frankfurt, 60596, Germany

Location

Site Reference ID/Investigator# 6760

Heidelberg, 69120, Germany

Location

Site Reference ID/Investigator# 6732

Mainz, D - 55116, Germany

Location

Site Reference ID/Investigator# 5018

Milan, 20132, Italy

Location

Site Reference ID/Investigator# 5006

Rome, 00133, Italy

Location

Site Reference ID/Investigator# 8427

Guadalajara, 44656, Mexico

Location

Site Reference ID/Investigator# 8497

Mexico City, C.P. 11650, Mexico

Location

Site Reference ID/Investigator# 8125

Monterrey, N.L., C.P. 64460, Mexico

Location

Site Reference ID/Investigator# 8120

Ponce, 00717-2075, Puerto Rico

Location

Site Reference ID/Investigator# 8121

San Juan, 00907, Puerto Rico

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Pain; Neuralgia

Interventions

3-(5,6-dichloropyridin-3-yl)-3,6-diazabicyclo(3.2.0)heptane; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wolfram Nothaft, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 27, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

DE (5); IT (2); CA (3); US (29); ME (3); FR (5); PR (2)