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A Randomized, Double-blind, Placebo- and Active-controlled Study of the Electric Current Effects of ABT-639 on the Spontaneous Activity of Pain Sensory Receptors in Patients With Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01589432
First Posted: May 2, 2012
Last Update Posted: January 3, 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) )
April 30, 2012
May 2, 2012
January 3, 2013
April 2012
November 2012   (Final data collection date for primary outcome measure)
Spontaneous activity in peripheral c-nociceptors [ Time Frame: 10 minute intervals over 180 minutes ]
Spontaneous activity in peripheral c-nociceptor measured through microneurography
Same as current
Complete list of historical versions of study NCT01589432 on ClinicalTrials.gov Archive Site
Pain intensity measurements [ Time Frame: hourly for 4 hours ]
Pain intensity reported on a numerical rating scale
Same as current
Not Provided
Not Provided
 
A Randomized, Double-blind, Placebo- and Active-controlled Study of the Electric Current Effects of ABT-639 on the Spontaneous Activity of Pain Sensory Receptors in Patients With Diabetic Peripheral Neuropathy
A Randomized, Double-blind, Placebo and Active-controlled Study of the Electrophysiological Effects of ABT-639 on Spontaneous Activity in C-Nociceptors in Patients With Painful Diabetic Peripheral Neuropathy
People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Diabetic Neuropathic Pain
  • Drug: ABT-639
    two 50 mg oral capsules
  • Drug: Placebo
    2 placebo capsules
  • Drug: Lidocaine
    3mg/kg infusion over 30 minutes
  • Experimental: ABT-639
    Intervention: Drug: ABT-639
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Lidocaine
    Intervention: Drug: Lidocaine
Serra J, Duan WR, Locke C, Solà R, Liu W, Nothaft W. Effects of a T-type calcium channel blocker, ABT-639, on spontaneous activity in C-nociceptors in patients with painful diabetic neuropathy: a randomized controlled trial. Pain. 2015 Nov;156(11):2175-83. doi: 10.1097/j.pain.0000000000000249.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
November 2012
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
  • Subject must have an average score of greater than or equal to 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

Exclusion Criteria

  • Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from diabetic neuropathic pain or interfere with the pain assessments of diabetic neuropathic pain.
  • A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with diabetic neuropathic pain assessments or other functions.
  • Subject has clinically significant abnormalities in clinical laboratory tests.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01589432
M13-383
2011-005127-40 ( EudraCT Number )
No
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Rita Jain, MD AbbVie
AbbVie
January 2013

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