A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00548925
First received: October 22, 2007
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Diabetic Neuropathic Pain
Drug: ABT-894
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Weekly mean of 24-hour average pain score [ Time Frame: Change from Baseline to final ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain improvement from Baseline to the final evaluation [ Time Frame: 8-week ] [ Designated as safety issue: No ]
  • Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain [ Time Frame: 8-week ] [ Designated as safety issue: No ]
  • Global assessments of study drug and pain status [ Time Frame: 8-week ] [ Designated as safety issue: No ]
  • Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS) [ Time Frame: 8-week ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ABT-894
6 mg BID tablets, 8 weeks of treatment
Placebo Comparator: 2 Drug: placebo
BID tablets, 8 weeks of treatment

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548925

  Hide Study Locations
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# 6616
San Antonio, Texas, United States, 78229
Site Reference ID/Investigator# 8179
San Antonio, Texas, United States, 78229-4801
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
France
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
Germany
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
Italy
Site Reference ID/Investigator# 5549
L'Aquila, Italy, 67100
Site Reference ID/Investigator# 5558
Perugia, Italy, 06126
Spain
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)
Investigators
Study Director: Rachel Duan, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00548925     History of Changes
Other Study ID Numbers: M10-014, 2007-001140-47
Study First Received: October 22, 2007
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 23, 2014