Status:
COMPLETED
A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Diabetic Neuropathy, Painful
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).
Eligibility Criteria
Inclusion
- Diagnosis of Type 1 or 2 diabetes mellitus.
- Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.
Exclusion
- Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
- Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00156078
Start Date
January 1 2005
End Date
May 1 2007
Last Update
January 25 2021
Active Locations (35)
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1
Pfizer Investigational Site
Buenos Aires, Argentina
2
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil
3
Pfizer Investigational Site
Niterói, Rio de Janeiro, Brazil
4
Pfizer Investigational Site
Valparaíso, Región de Valparaíso, Chile