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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ABT-639

Group Type EXPERIMENTAL

ABT-639

Intervention Type DRUG

two 50 mg oral capsules

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 placebo capsules

Lidocaine

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

3mg/kg infusion over 30 minutes

Interventions

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ABT-639

two 50 mg oral capsules

Intervention Type DRUG

Placebo

2 placebo capsules

Intervention Type DRUG

Lidocaine

3mg/kg infusion over 30 minutes

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No