A LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY STUDY OF PREGABALIN IN THE TREATMENT OF POSTHERPETIC NEURALGIA.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.33 sites in 1 country126 target enrollmentJanuary 12, 2007

ConditionsNeuralgia, Postherpetic

Interventionspregabalin

Drugspregabalin

Overview

Phase: Phase 3
Intervention: pregabalin
Conditions: Neuralgia, Postherpetic
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 126
Locations: 33
Primary Endpoint: Summary of Adverse Events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the safety of the long-term use of pregabalin.

Registry

clinicaltrials.gov

Start Date

January 12, 2007

End Date

August 19, 2008

Last Updated

4 years ago

Study Type

Interventional

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 postherpetic neuralgia 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 (A0081120) 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 (A0081120)

Arms & Interventions

pregabalin

Intervention: pregabalin

Outcomes

Primary Outcomes

Summary of Adverse Events

Time Frame: 52 weeks

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

Secondary Outcomes

Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score(52 weeks)
Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale(52 weeks)
Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score(52 weeks)
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score(52 weeks)
Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity(52 weeks)