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

Phase 3

Completed

• Conditions: Diabetic Neuropathy, Painful
• Interventions: Drug: pregabalin

• Registration Number: NCT00553280
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-04
• Study Start: 2008-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2010-12-07
• Results First Submitted QC: 2010-12-07
• Results First Posted: 2011-01-05
• Status Verified: 2011-04
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pregabalin	pregabalin	-

Primary Outcome Measures

Name	Time	Method
Summary of Adverse Events	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 Outcome Measures

Name	Time	Method
Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores	From baseline to 52 weeks or study discontinuation (Study Endpoint)	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.
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores	From baseline to 52 weeks or study discontinuation (Study Endpoint)	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.
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores	From baseline to 52 weeks or study discontinuation (Study Endpoint)	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.
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores	From baseline to 52 weeks or study discontinuation (Study Endpoint)	The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores	From baseline to 52 weeks or study discontinuation (Study Endpoint)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Tokushima, Japan