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A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00548925
First Posted: October 24, 2007
Last Update Posted: January 21, 2013
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.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
October 22, 2007
October 24, 2007
January 21, 2013
November 2007
December 2008   (Final data collection date for primary outcome measure)
Weekly mean of 24-hour average pain score [ Time Frame: Change from Baseline to final ]
Same as current
Complete list of historical versions of study NCT00548925 on ClinicalTrials.gov Archive Site
  • Pain improvement from Baseline to the final evaluation [ Time Frame: 8-week ]
  • Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain [ Time Frame: 8-week ]
  • Global assessments of study drug and pain status [ Time Frame: 8-week ]
  • Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS) [ Time Frame: 8-week ]
  • Pain improvement from Baseline to the final evaluation [ Time Frame: 8-week ]
  • Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain [ Time Frame: 8-week ]
  • Global assessments of study drug and pain status [ Time Frame: 8-week ]
  • Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 8-week ]
  • Neuropathic Pain Scale (NPS) [ Time Frame: 8-week ]
Not Provided
Not Provided
 
A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Neuropathic Pain
  • Drug: ABT-894
    6 mg BID tablets, 8 weeks of treatment
  • Drug: placebo
    BID tablets, 8 weeks of treatment
  • Experimental: 1
    Intervention: Drug: ABT-894
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
December 2008
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT00548925
M10-014
2007-001140-47 ( EudraCT Number )
No
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Rachel Duan, MD AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP