A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
Phase 4
Completed
- Conditions
- Diabetic Neuropathy, Painful
- Registration Number
- NCT00156078
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
- Diagnosis of Type 1 or 2 diabetes mellitus.
- Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.
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Exclusion Criteria
- 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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean pain score
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site