To Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

Pfizer

Status and phase: Completed; Phase 3

Conditions: Diabetic Neuropathy, Painful

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150423

1008-165

Details and patient eligibility

About

To evaluate the safety and efficacy of pregabalin in patients with painful diabetic peripheral neuropathy.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)