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A Study for Treatment of Pain in Patients With Diabetic Neuropathy.

NCT00785577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2012-05-31

Study results available
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Summary

The purpose of this study is to test whether a new treatment will be safe and effective in treating pain. Patients with diabetic peripheral neuropathy will be included.

Conditions

  • Diabetic Neuropathy, Painful

Interventions

DRUG

Placebo

LY545694 placebo BID po for 5 weeks Pregabalin placebo capsules TID po for 6 weeks

DRUG

Pregabalin

Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6 LY545694 placebo BID po for 5 weeks

DRUG

LY545694 21 mg

LY545694 21 mg BID po for 1 week Pregabalin placebo TID po for 6 weeks

DRUG

LY545694 49 mg

LY545694 escalated to 49 mg BID po for 1 week during Week 2. Pregabalin placebo TID po for 6 weeks.

DRUG

LY545694 105 mg

LY545694 105 mg BID po for 5 weeks Pregabalin placebo TID po for 6 weeks

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

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
2008-11-30
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • United States
  • Mexico
  • Puerto Rico

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 NCT00785577 on ClinicalTrials.gov