An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country123 target enrollmentFebruary 2008

ConditionsDiabetic Neuropathy, Painful

Interventionspregabalin

Drugspregabalin

Overview

Phase: Phase 3
Intervention: pregabalin
Conditions: Diabetic Neuropathy, Painful
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 123
Locations: 1
Primary Endpoint: Summary of Adverse Events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

January 2010

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A
•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)

Arms & Interventions

pregabalin

Intervention: pregabalin

Outcomes

Primary Outcomes

Summary of Adverse Events

Time Frame: 53 weeks

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.

Secondary Outcomes

Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores(From baseline to 52 weeks or study discontinuation (Study Endpoint))
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores(From baseline to 52 weeks or study discontinuation (Study Endpoint))
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores(From baseline to 52 weeks or study discontinuation (Study Endpoint))
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores(From baseline to 52 weeks or study discontinuation (Study Endpoint))
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores(From baseline to 52 weeks or study discontinuation (Study Endpoint))