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A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)

NCT00643760 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2013-07-22

Study results available
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Summary

The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)

Conditions

  • Neuropathy, Diabetic

Interventions

DRUG

Placebo

placebo

DRUG

GEn 1200mg/day

gabapentin enacarbil 1200mg/day

DRUG

GEn 2400mg/day

gabapentin enacarbil 2400mg/day

DRUG

GEn 3600mg/day

gabapentin enacarbil 3600mg/day

DRUG

Pregabalin

pregabalin 300mg/day

Sponsors & Collaborators

  • XenoPort, Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

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 NCT00643760 on ClinicalTrials.gov