A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

January 3, 2013 updated by: AbbVie (prior sponsor, Abbott)

A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

193

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

  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 03
        • Site Reference ID/Investigator# 51425
      • Mor Ostrava, Czech Republic, 702 00
        • Site Reference ID/Investigator# 51426
      • Olomouc, Czech Republic, 77900
        • Site Reference ID/Investigator# 51424
      • Prague 10, Czech Republic, 100 00
        • Site Reference ID/Investigator# 51428
      • Prague 6, Czech Republic, 160 00
        • Site Reference ID/Investigator# 51423
      • Zlin, Czech Republic, 760 01
        • Site Reference ID/Investigator# 51427
  • France
      • Le Creusot, France, 71200
        • Site Reference ID/Investigator# 51924
      • Venissieux, France, 69200
        • Site Reference ID/Investigator# 51925
  • Germany
      • Berlin, Germany, 10115
        • Site Reference ID/Investigator# 51503
      • Duesseldorf, Germany, 40225
        • Site Reference ID/Investigator# 51642
      • Mainz, Germany, D - 55116
        • Site Reference ID/Investigator# 51502
      • Muenster, Germany, 48145
        • Site Reference ID/Investigator# 52346
  • Mexico
      • Guadalajara, Jal., Mexico, C.P. 44130
        • Site Reference ID/Investigator# 51505
      • Mexico D.F., Mexico, C.P. 11650
        • Site Reference ID/Investigator# 51504
      • Monterrey, N.L., Mexico, C.P. 64000
        • Site Reference ID/Investigator# 51522
      • Monterrey, N.L., Mexico, C.P. 64460
        • Site Reference ID/Investigator# 51506
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Site Reference ID/Investigator# 51807
    • California
      • Anaheim, California, United States, 92801
        • Site Reference ID/Investigator# 51946
      • Long Beach, California, United States, 90806
        • Site Reference ID/Investigator# 51468
      • Walnut Creek, California, United States, 94598
        • Site Reference ID/Investigator# 52744
    • Florida
      • Clearwater, Florida, United States, 33765
        • Site Reference ID/Investigator# 51079
      • Hialeah, Florida, United States, 33012
        • Site Reference ID/Investigator# 51076
      • Hollywood, Florida, United States, 33021
        • Site Reference ID/Investigator# 51945
      • Ocala, Florida, United States, 34471
        • Site Reference ID/Investigator# 51077
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 51078
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Site Reference ID/Investigator# 51804
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 51263
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 51268
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Site Reference ID/Investigator# 51302
    • New York
      • Flushing, New York, United States, 11365
        • Site Reference ID/Investigator# 51271
    • Oregon
      • Portland, Oregon, United States, 97239
        • Site Reference ID/Investigator# 52743
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Site Reference ID/Investigator# 51806
      • Tipton, Pennsylvania, United States, 16684
        • Site Reference ID/Investigator# 51265
    • Texas
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 51548
    • Washington
      • Renton, Washington, United States, 98055
        • Site Reference ID/Investigator# 51269

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:

  • Subject is between the ages of 18 to 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 an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

Exclusion Criteria:

  • Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
  • A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
  • Subject has clinically significant abnormalities in clinical laboratory tests.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABT-639
ABT-639 twice daily for 6 weeks
Drug: ABT-639
ABT-639 Twice Daily for six weeks.
Active Comparator: pregabalin
pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study
Drug: pregabalin
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
Other Names:
  • Lyrica
Placebo Comparator: Placebo
Placebo twice daily for 6 weeks
Drug: Placebo
Placebo twice daily for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
Time Frame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)
Daily questions asked on a hand held diary
Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's Global Impression of Change
Time Frame: Week 2, Week 4 and Week 6 (End of Study)
Paper questionnaire
Week 2, Week 4 and Week 6 (End of Study)
Brief Pain Inventory (BPI) (short form) including Severity and Interference
Time Frame: At each visit up to Week 6 (end of Study)
Paper questionnaire
At each visit up to Week 6 (end of Study)
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: Baseline, Week 2, Week 4 and Week 6 (end of Study)
Paper questionnaire
Baseline, Week 2, Week 4 and Week 6 (end of Study)

Collaborators and Investigators

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

Sponsor

AbbVie (prior sponsor, Abbott)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimate)

April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M11-891
  • 2010-024359-99 (EudraCT Number)

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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