MedTrace Logo

A Study in Painful Diabetic Neuropathy

NCT01089556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 811

Last updated 2013-01-24

Study results available
· View outcomes & findings →

Summary

This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.

Conditions

  • Diabetic Neuropathy, Painful

Interventions

DRUG

Duloxetine

Administered orally

DRUG

Pregabalin

Administered orally

DRUG

Placebo

Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5AM 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Australia
  • Canada
  • Croatia
  • France
  • Germany
  • Greece
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

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 NCT01089556 on ClinicalTrials.gov