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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014