Status:
COMPLETED
A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
51+ years
Phase:
PHASE4
Brief Summary
The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patien...
Eligibility Criteria
Inclusion
- Patients with stable Diabetes Mellitus 1 or 2
- Clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8 weeks
- No clinically significant motor deficits
- Pain described according to at least one of the following clinical manifestations: burning, cramps or twinges, thermal or mechanical alodinea
Exclusion
- Treatment with any medication that may interfere with the assessment of gabapentin during the study or within 7 days of the adminstration of gabapentin
- Specific systemic diseases or other medical conditions that would interfere with the assessment of gabapentin therapeutic response or safety
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00644748
Start Date
May 1 2003
End Date
August 1 2004
Last Update
February 2 2021
Active Locations (10)
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1
Pfizer Investigational Site
Fortaleza, Ceará, Brazil, 60120-021
2
Pfizer Investigational Site
Taguatinga, Federal District, Brazil, 72119-900
3
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
4
Pfizer Investigational Site
Curitiba, Paraná, Brazil, 80060-150