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

Phase 2

Completed

• Conditions: Diabetic Neuropathic Pain
• Interventions: Drug: Placebo; Drug: Lidocaine; Drug: ABT-639

• Registration Number: NCT01589432
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-02
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Lidocaine	Lidocaine	-
ABT-639	ABT-639	-

Primary Outcome Measures

Name	Time	Method
Spontaneous activity in peripheral c-nociceptors	10 minute intervals over 180 minutes	Spontaneous activity in peripheral c-nociceptor measured through microneurography

Secondary Outcome Measures

Name	Time	Method
Pain intensity measurements	hourly for 4 hours	Pain intensity reported on a numerical rating scale

Trial Locations

Locations (1)

Site Reference ID/Investigator# 68882; 🇬🇧 London, United Kingdom