Safety and Efficacy of Pregabalin in Patients With Diabetic Peripheral Neuropathy.

Pfizer

Status and phase: Completed; Phase 3

Conditions: Diabetic Neuropathy, Painful

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141401

1008-074

Details and patient eligibility

About

To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)