To Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
Phase 3
Completed
- Conditions
- Diabetic Neuropathy, Painful
- Registration Number
- NCT00150423
- Lead Sponsor
- Pfizer
- Brief Summary
To evaluate the safety and efficacy of pregabalin in patients with painful diabetic peripheral neuropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 384
Inclusion Criteria
- Must have met the inclusion criteria for the preceding double-blind BID study in painful diabetic peripheral neuropathy
- Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks.
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Exclusion Criteria
- Patients may not participate if they experienced a serious adverse event during the preceding double-blind BID study which was determined to be related to the study medication.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety Efficacy
- Secondary Outcome Measures
Name Time Method