A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

Viatris

Status and phase: Completed; Phase 3

Conditions: Diabetic Neuropathy, Painful

Treatments: Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00553280

A0081164

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A0081163.
• Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study

Exclusion criteria

• Patients who experienced serious adverse events in the preceding study (A0081163) that were determined by the investigator or the study sponsor to be causally related to the study medication.
• Patients exhibiting treatment non-compliance in the preceding study (A0081163)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

pregabalin

Experimental group

Treatment:

Drug: pregabalin