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Efficacy and Safety Study of TAK-128 in Treating Subjects With Diabetic Peripheral Neuropathy

NCT00229437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2012-02-28

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of TAK-128, once daily (QD), in treating subjects with diabetic peripheral neuropathy.

Conditions

  • Diabetic Neuropathies

Interventions

DRUG

TAK-128

TAK-128 5 mg, tablets, orally, once daily for up to 6 months.

DRUG

TAK-128

TAK-128 50 mg, tablets, orally, once daily for up to 6 months.

DRUG

TAK-128

TAK-128 100 mg, tablets, orally, once daily for up to 6 months.

DRUG

Placebo

TAK-128 placebo-matching tablets, orally, once daily for up to 6 months.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2006-05-31
Completion
2006-05-31

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 NCT00229437 on ClinicalTrials.gov