A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

January 11, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

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# 5552
      • Olomouc, Czech Republic, 77900
        • Site Reference ID/Investigator# 5554
      • Zlin, Czech Republic, 760 01
        • Site Reference ID/Investigator# 5553
  • France
      • Corbeil Essonnes, France, 91106
        • Site Reference ID/Investigator# 9363
      • Limoges, France, 87042
        • Site Reference ID/Investigator# 5557
      • Nevers, France, 58033
        • Site Reference ID/Investigator# 6238
  • Germany
      • Bad Mergentheim, Germany, 97980
        • Site Reference ID/Investigator# 6564
      • Berlin, Germany, 10115
        • Site Reference ID/Investigator# 11201
      • Duesseldorf, Germany, 40225
        • Site Reference ID/Investigator# 6234
      • Mainz, Germany, D - 55116
        • Site Reference ID/Investigator# 11202
      • Munich, Germany, 80804
        • Site Reference ID/Investigator# 7714
  • Italy
      • L'Aquila, Italy, 67100
        • Site Reference ID/Investigator# 5549
      • Perugia, Italy, 06126
        • Site Reference ID/Investigator# 5558
  • Spain
      • Granada, Spain, 18014
        • Site Reference ID/Investigator# 6475
      • Sabadell, Barcelona, Spain, 8208
        • Site Reference ID/Investigator# 7911
  • United Kingdom
      • Birmingham, United Kingdom, B29 6JD
        • Site Reference ID/Investigator# 5555
      • Sheffield, United Kingdom, S5 7AU
        • Site Reference ID/Investigator# 7133
  • United States
    • California
      • Spring Valley, California, United States, 91978
        • Site Reference ID/Investigator# 6614
      • Walnut Creek, California, United States, 94598
        • Site Reference ID/Investigator# 6617
    • Florida
      • Hollywood, Florida, United States, 33021
        • Site Reference ID/Investigator# 6356
      • Tampa, Florida, United States, 33603
        • Site Reference ID/Investigator# 6615
      • Wellington, Florida, United States, 33414
        • Site Reference ID/Investigator# 6358
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 6609
    • New York
      • New Hyde Park, New York, United States, 11042
        • Site Reference ID/Investigator# 7229
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Site Reference ID/Investigator# 6618
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Site Reference ID/Investigator# 6607
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Site Reference ID/Investigator# 6575
    • Texas
      • San Antonio, Texas, United States, 78229-4801
        • Site Reference ID/Investigator# 8179
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 6616

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:

  • Males and females, age 18 to 75
  • If female, must be of non-childbearing potential or practicing birth control
  • Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy
  • Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months
  • Must be willing to washout of all analgesic medications prior to entry into the study

Exclusion Criteria:

  • Has other conditions that may cause pain
  • Currently receiving analgesic medications for conditions other than diabetic neuropathic pain
  • Has a history of certain psychiatric diseases
  • Has a history of certain heart or cardiovascular conditions
  • Has any clinically significant recent infection, injury, or illness
  • Current participation in another clinical study or participation within the past 30 days
  • Is incapacitated, bedridden or confined to a wheelchair
  • Is pregnant and/or breastfeeding
  • Previous participation in this study or any other study with this investigational product.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ABT-894
6 mg BID tablets, 8 weeks of treatment
Placebo Comparator: 2
Drug: placebo
BID tablets, 8 weeks of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weekly mean of 24-hour average pain score
Time Frame: Change from Baseline to final
Change from Baseline to final

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain improvement from Baseline to the final evaluation
Time Frame: 8-week
8-week
Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain
Time Frame: 8-week
8-week
Global assessments of study drug and pain status
Time Frame: 8-week
8-week
Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)
Time Frame: 8-week
8-week

Collaborators and Investigators

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

Sponsor

AbbVie (prior sponsor, Abbott)

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

November 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimate)

October 24, 2007

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-014
  • 2007-001140-47 (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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