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

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetic Neuropathy, Painful

Intervention / Treatment
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* Drug: pregabalin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pregabalin<br> | Drug: pregabalin<br>* Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 53 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | From baseline to 52 weeks or study discontinuation (Study Endpoint) | 
| Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | 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. | From baseline to 52 weeks or study discontinuation (Study Endpoint) |