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Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy

NCT00760955 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2016-06-22

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and effectiveness of TAK-583, once daily (QD), in the treatment of neuropathy caused by diabetes mellitus.

Conditions

  • Diabetic Neuropathies

Interventions

DRUG

TAK-583

TAK-583 5 mg, tablets, orally, once daily for up to 6 months.

DRUG

TAK-583

TAK-583 50 mg, tablets, orally, once daily for up to 6 months.

DRUG

TAK-583

TAK-583 100 mg, tablets, orally, once daily for up to 6 months.

DRUG

Placebo

TAK-583 placebo-matching tablets, orally, once daily for up to 6 months.

Sponsors & Collaborators

Principal Investigators

  • VP Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00760955 on ClinicalTrials.gov