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An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain

NCT00385671 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2011-07-26

Study results available
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Summary

To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.

Conditions

  • Diabetic Neuropathy, Painful

Interventions

DRUG

duloxetine hydrochloride

Duloxetine (DLX) once daily (QD), orally (PO)

DRUG

pregabalin

Pregabalin (PGB) orally (PO)

DRUG

gabapentin

Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study)

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
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-08-31
Completion
2009-11-30

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

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 NCT00385671 on ClinicalTrials.gov