NCT00141401CompletedPhase 3
An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 240
- Primary Endpoint
- Safety Efficacy
Study Overview
Brief Summary
To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must have met the inclusion criteria for preceding double-blind study
- •Must have received pregabalin or amitriptyline or placebo under double-blind conditions under double-blind conditions at least during first 3 weeks if double-blind treatment phase of preceding study.
Exclusion Criteria
- •Patients cannot be included if they experienced a serious adverse event while participating in preceding double-blind study, which was determined to be related to the study medication.
Outcomes
Primary Outcomes
Safety Efficacy
Secondary Outcomes
No secondary outcomes reported
Investigators
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