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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety Efficacy
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie pregabalin's analgesic effects in painful diabetic peripheral neuropathy?
How does pregabalin compare to gabapentin in managing neuropathic pain in diabetic patients?
Which biomarkers correlate with pregabalin response in painful diabetic peripheral neuropathy patients?
What are the long-term adverse events associated with pregabalin in diabetic neuropathy trials?
Are there combination therapies involving pregabalin that improve outcomes for painful diabetic peripheral neuropathy?