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A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

NCT01345045 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2013-01-08

No results posted yet for this study

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.

Conditions

  • Diabetic Neuropathic Pain

Interventions

DRUG

ABT-639

ABT-639 Twice Daily for six weeks.

DRUG

pregabalin

pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.

DRUG

Placebo

Placebo twice daily for 6 weeks.

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Rachel Duan, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01345045 on ClinicalTrials.gov