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Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

NCT00507936 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2013-01-23

No results posted yet for this study

Summary

This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.

Conditions

  • Diabetic Neuralgia
  • Diabetic Neuropathies
  • Diabetic Neuropathy, Painful
  • Diabetic Polyneuropathy
  • Neuralgia, Diabetic

Interventions

DRUG

ABT-894

ABT-894 1 mg capsule BID throughout treatment period

DRUG

ABT-894

ABT-894 2 mg capsule BID throughout treatment period

DRUG

ABT-894

ABT-894 4 mg capsule BID throughout treatment period

DRUG

placebo

placebo capsule BID throughout the treatment period

DRUG

Duloxetine

Duloxetine 60 mg QD throughout treatment period

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Wolfram Nothaft, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Mexico
  • Puerto Rico

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 NCT00507936 on ClinicalTrials.gov