Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Neuropathic Pain

Keywords

Diabetic peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Pain intensity measurements
hourly for 4 hours

Study Arms (3)

ABT-639

EXPERIMENTAL

Drug: ABT-639

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Lidocaine

ACTIVE COMPARATOR

Drug: Lidocaine

Interventions

ABT-639Drug

two 50 mg oral capsules

ABT-639

PlaceboDrug

2 placebo capsules

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

AbbVie (prior sponsor, Abbott)
Industrylead

Study Sites (1)

Site Reference ID/Investigator# 68882

London, SE1 3XF, United Kingdom

Related Publications (1)

Serra J, Duan WR, Locke C, Sola 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):2175-2183. doi: 10.1097/j.pain.0000000000000249.
PMID: 26035253DERIVED

MeSH Terms

Interventions

4-chloro-2-fluoro-N-(2-fluorophenyl)-5-(hexahydropyrrolo(1,2-a)pyrazin-2(1H)-ylcarbonyl)benzenesulfonamideLidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

Rita Jain, MD
AbbVie
STUDY DIRECTOR

Enrollment

39 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 2, 2012

Study Start

April 2012

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

ABT-639

Placebo

Lidocaine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

ABT-639

Placebo

Lidocaine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations