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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:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01589432
First received: April 30, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathic Pain
 Drug: ABT-639
Drug: Placebo
Drug: Lidocaine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Spontaneous activity in peripheral c-nociceptors [ Time Frame: 10 minute intervals over 180 minutes ] [ Designated as safety issue: No ]
    Spontaneous activity in peripheral c-nociceptor measured through microneurography


Secondary Outcome Measures:
  • Pain intensity measurements [ Time Frame: hourly for 4 hours ] [ Designated as safety issue: No ]
    Pain intensity reported on a numerical rating scale


Enrollment: 39
Study Start Date: April 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-639 Drug: ABT-639
two 50 mg oral capsules
Placebo Comparator: Placebo Drug: Placebo
2 placebo capsules
Active Comparator: Lidocaine Drug: Lidocaine
3mg/kg infusion over 30 minutes

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589432

Locations
United Kingdom
Site Reference ID/Investigator# 68882
London, United Kingdom, SE1 3XF
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Rita Jain, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01589432     History of Changes
Other Study ID Numbers: M13-383, 2011-005127-40
Study First Received: April 30, 2012
Last Updated: January 2, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AbbVie:
Diabetic peripheral neuropathy

Additional relevant MeSH terms:
Neuralgia
Peripheral Nervous System Diseases
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lidocaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013