A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain

AbbVie (prior sponsor, Abbott)35 sites in 5 countries193 target enrollmentApril 2011

ConditionsDiabetic Neuropathic Pain

InterventionsABT-639 pregabalin Placebo

DrugsPlacebo ABT-639 pregabalin

Overview

Phase: Phase 2
Intervention: ABT-639
Conditions: Diabetic Neuropathic Pain
Sponsor: AbbVie (prior sponsor, Abbott)
Enrollment: 193
Locations: 35
Primary Endpoint: A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

October 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AbbVie (prior sponsor, Abbott)

Responsible Party

Sponsor

Eligibility 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 (DNP) or interfere with the pain assessments of DNP.
•A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
•Subject has clinically significant abnormalities in clinical laboratory tests.

Arms & Interventions

ABT-639

ABT-639 twice daily for 6 weeks

Intervention: ABT-639

pregabalin

pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study

Intervention: pregabalin

Placebo

Placebo twice daily for 6 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary

Time Frame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)

Daily questions asked on a hand held diary

Secondary Outcomes

Patient's Global Impression of Change(Week 2, Week 4 and Week 6 (End of Study))
Brief Pain Inventory (BPI) (short form) including Severity and Interference(At each visit up to Week 6 (end of Study))
Neuropathic Pain Symptom Inventory (NPSI)(Baseline, Week 2, Week 4 and Week 6 (end of Study))