Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

January 15, 2013 updated by: AbbVie (prior sponsor, Abbott)

A Global, Multicenter, Randomized, Double-Blind Placebo Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects With Diabetic Neuropathic Pain

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kingston, Canada, K7L 1G1
        • Site Reference ID/Investigator# 8508
      • Laval, Canada, H7T 2P5
        • Site Reference ID/Investigator# 8436
      • Winnipeg, Canada, R2V 4W3
        • Site Reference ID/Investigator# 8481
      • Corbeil Essonnes, France, 91106
        • Site Reference ID/Investigator# 5258
      • Nanterre, France, 92104
        • Site Reference ID/Investigator# 7696
      • Narbonne, France, 11108
        • Site Reference ID/Investigator# 5260
      • Nevers, France, 58033
        • Site Reference ID/Investigator# 5171
      • Nimes, France, 30029
        • Site Reference ID/Investigator# 7115
      • Berlin, Germany, 10115
        • Site Reference ID/Investigator# 6763
      • Essen, Germany, 45138
        • Site Reference ID/Investigator# 7117
      • Frankfurt, Germany, 60596
        • Site Reference ID/Investigator# 5034
      • Heidelberg, Germany, 69120
        • Site Reference ID/Investigator# 6760
      • Mainz, Germany, D - 55116
        • Site Reference ID/Investigator# 6732
      • Milan, Italy, 20132
        • Site Reference ID/Investigator# 5018
      • Rome, Italy, 00133
        • Site Reference ID/Investigator# 5006
      • Guadalajara, Mexico, 44656
        • Site Reference ID/Investigator# 8427
      • Mexico D.F., Mexico, C.P. 11650
        • Site Reference ID/Investigator# 8497
      • Monterrey, N.L., Mexico, C.P. 64460
        • Site Reference ID/Investigator# 8125
      • Ponce, Puerto Rico, 00717-2075
        • Site Reference ID/Investigator# 8120
      • San Juan, Puerto Rico, 00907
        • Site Reference ID/Investigator# 8121
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Site Reference ID/Investigator# 5207
      • Phoenix, Arizona, United States, 85023
        • Site Reference ID/Investigator# 6053
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Site Reference ID/Investigator# 5206
      • North Little Rock, Arkansas, United States, 72114
        • Site Reference ID/Investigator# 7387
    • California
      • Anaheim, California, United States, 92801
        • Site Reference ID/Investigator# 6052
      • Garden Grove, California, United States, 92845
        • Site Reference ID/Investigator# 7064
      • National City, California, United States, 91950
        • Site Reference ID/Investigator# 8286
    • Florida
      • Clearwater, Florida, United States, 33765
        • Site Reference ID/Investigator# 5276
      • Hialeah, Florida, United States, 33012
        • Site Reference ID/Investigator# 6781
      • Palm Beach Gardens, Florida, United States, 33418
        • Site Reference ID/Investigator# 7514
      • Tampa, Florida, United States, 33603
        • Site Reference ID/Investigator# 8113
    • Maryland
      • Pasadena, Maryland, United States, 21122
        • Site Reference ID/Investigator# 6047
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Site Reference ID/Investigator# 5277
    • Missouri
      • St. Louis, Missouri, United States, 63117
        • Site Reference ID/Investigator# 6043
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 6044
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Site Reference ID/Investigator# 7906
    • New York
      • New York, New York, United States, 10003
        • Site Reference ID/Investigator# 6045
      • New York, New York, United States, 10022
        • Site Reference ID/Investigator# 5946
      • New York, New York, United States, 10065
        • Site Reference ID/Investigator# 5216
      • New York, New York, United States, 10128
        • Site Reference ID/Investigator# 7483
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Site Reference ID/Investigator# 5947
      • Cuyahoga Falls, Ohio, United States, 44223
        • Site Reference ID/Investigator# 6869
    • Oregon
      • Portland, Oregon, United States, 97239
        • Site Reference ID/Investigator# 5217
    • Texas
      • Houston, Texas, United States, 77074
        • Site Reference ID/Investigator# 7699
      • San Antonio, Texas, United States, 78218
        • Site Reference ID/Investigator# 5836
      • San Antonio, Texas, United States, 78229-4801
        • Site Reference ID/Investigator# 5899
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 5950
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 7187
    • Washington
      • Seattle, Washington, United States, 98104
        • Site Reference ID/Investigator# 6054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: D
placebo capsule BID throughout the treatment period
Experimental: A
ABT-894 1 mg BID
ABT-894 1 mg capsule BID throughout treatment period
ABT-894 2 mg capsule BID throughout treatment period
ABT-894 4 mg capsule BID throughout treatment period
Experimental: B
ABT-894 2 mg BID
ABT-894 1 mg capsule BID throughout treatment period
ABT-894 2 mg capsule BID throughout treatment period
ABT-894 4 mg capsule BID throughout treatment period
Experimental: C
ABT-894 4 mg BID
ABT-894 1 mg capsule BID throughout treatment period
ABT-894 2 mg capsule BID throughout treatment period
ABT-894 4 mg capsule BID throughout treatment period
Active Comparator: E
Duloxetine 60 mg QD
Duloxetine 60 mg QD throughout treatment period

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportions of treatment responders; subjects who complete treatment period with 30% improvement
Time Frame: From Baseline to final 24-hour average pain score
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
Time Frame: Weekly through treatment phase
Weekly through treatment phase
Brief Pain Inventory (BPI) (short form) including Pain Severity
Time Frame: At each visit from Baseline to Week 8 visit
At each visit from Baseline to Week 8 visit
Clinician Global Impression: Severity (CGI-S) and Patient Global Impression: Change (PGI-C)
Time Frame: At each visit from Baseline to Week 8 visit
At each visit from Baseline to Week 8 visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

July 25, 2007

First Submitted That Met QC Criteria

July 25, 2007

First Posted (Estimate)

July 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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