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Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy

NCT00619983 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-09-11

Study results available
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Summary

The purpose of the study is to determine whether the combination of the the three drugs gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic neuropathy or patients with failed low back syndrome (chronic back pain).

Conditions

  • Diabetic Neuropathic Pain
  • Chronic Low Back Pain

Interventions

DRUG

donepezil

Group 1: Will receive donepezil 5mg once a day

DRUG

duloxetine

Group 2: Will receive duloxetine 30 mg twice a day

DRUG

donepezil 2.5 mg and duloxetine 30mg

Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg

DRUG

placebo

Group 4: Will receive placebo pills

DRUG

gabapentin

Week 8: all subjects will have open label gabapentin added to their randomized study medication

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Wake Forest University

    lead OTHER

Principal Investigators

  • James C Eisenach, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2013-05-31
Completion
2013-05-31
FDA Drug
Yes

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 NCT00619983 on ClinicalTrials.gov