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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.123 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Diabetic Neuropathy, Painful

Interventions

pregabalinDRUG

Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (27)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Outcomes

Primary Outcomes

Summary of Adverse Events

Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.

Time frame: 53 weeks

Secondary Outcomes

Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.

Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.

Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.

Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.

Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.