A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00548925
Recruitment Status : Completed
First Posted : October 24, 2007
Last Update Posted : January 21, 2013
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diabetic Neuropathic Pain Drug: ABT-894 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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

Primary Outcome Measures :
  1. Weekly mean of 24-hour average pain score [ Time Frame: Change from Baseline to final ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00548925

  Hide Study Locations
United States, California
Site Reference ID/Investigator# 6614
Spring Valley, California, United States, 91978
Site Reference ID/Investigator# 6617
Walnut Creek, California, United States, 94598
United States, Florida
Site Reference ID/Investigator# 6356
Hollywood, Florida, United States, 33021
Site Reference ID/Investigator# 6615
Tampa, Florida, United States, 33603
Site Reference ID/Investigator# 6358
Wellington, Florida, United States, 33414
United States, Missouri
Site Reference ID/Investigator# 6609
St. Louis, Missouri, United States, 63141
United States, New York
Site Reference ID/Investigator# 7229
New Hyde Park, New York, United States, 11042
United States, North Carolina
Site Reference ID/Investigator# 6618
Charlotte, North Carolina, United States, 28211
United States, Oklahoma
Site Reference ID/Investigator# 6607
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Site Reference ID/Investigator# 6575
Allentown, Pennsylvania, United States, 18103
United States, Texas
Site Reference ID/Investigator# 8179
San Antonio, Texas, United States, 78229-4801
Site Reference ID/Investigator# 6616
San Antonio, Texas, United States, 78229
Czech Republic
Site Reference ID/Investigator# 5552
Hradec Kralove, Czech Republic, 500 03
Site Reference ID/Investigator# 5554
Olomouc, Czech Republic, 77900
Site Reference ID/Investigator# 5553
Zlin, Czech Republic, 760 01
Site Reference ID/Investigator# 9363
Corbeil Essonnes, France, 91106
Site Reference ID/Investigator# 5557
Limoges, France, 87042
Site Reference ID/Investigator# 6238
Nevers, France, 58033
Site Reference ID/Investigator# 6564
Bad Mergentheim, Germany, 97980
Site Reference ID/Investigator# 11201
Berlin, Germany, 10115
Site Reference ID/Investigator# 6234
Duesseldorf, Germany, 40225
Site Reference ID/Investigator# 11202
Mainz, Germany, D - 55116
Site Reference ID/Investigator# 7714
Munich, Germany, 80804
Site Reference ID/Investigator# 5549
L'Aquila, Italy, 67100
Site Reference ID/Investigator# 5558
Perugia, Italy, 06126
Site Reference ID/Investigator# 6475
Granada, Spain, 18014
Site Reference ID/Investigator# 7911
Sabadell, Barcelona, Spain, 8208
United Kingdom
Site Reference ID/Investigator# 5555
Birmingham, United Kingdom, B29 6JD
Site Reference ID/Investigator# 7133
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Rachel Duan, MD AbbVie

Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT00548925     History of Changes
Other Study ID Numbers: M10-014
2007-001140-47 ( EudraCT Number )
First Posted: October 24, 2007    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms