A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain

Study Overview
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Brief Summary
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This study is to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic pain.

Official Title
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A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain

Conditions
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Neuropathic Pain, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: pregabalin sustained release tablet
* Drug: pregabalin immediate release capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 19 years, < 75 years VAS score for diabetic peripheral neuropathy pain ≥ 30 Patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeks Type II DM patient and HbA1c ≤ 10 % Written informed consent Exclusion Criteria: Patient with hypersensitivity to pregabalin Patient on anti-epileptic drugs Patients with pain caused by other factors than diabetic peripheral neuropathy Patients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screening AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease Drug-abusing patient Severe depression or uncontrolled abnormal mood and behavioral changes Pregnant and breast-feeding woman Patients who participated in other clinical trials for investigational products within 30 days of screening Patients deemed to be ineligible to participate in the trial by investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 74 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pregabalin sustained release tablet<br>pregabalin sustained release tablet 150mg qd for 8weeks | Drug: pregabalin sustained release tablet<br>* pregabalin sustained release tablet 150mg qd for 8weeks<br>|
| Active Comparator: pregabalin immediate release capsule<br>pregabalin immediate release capsule 75mg bid for 8weeks | Drug: pregabalin immediate release capsule<br>* pregabalin immediate release capsule 75mg bid for 8weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 8 in Visual Analogue Scale(VAS) |  | Baseline/Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 8 in Quality of Life(EQ-5D) |  | Baseline/Week 8 | 
| Change from baseline to week 8 in Patients Global Impression of Change(PGIC) |  | Baseline/Week 8 | 
| Change from baseline to week 8 in Clinician Global Impression of Change(CGIC) |  | Baseline/Week 8 | 
| Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS) |  | Baseline/Week 8 | 
| Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8) |  | Baseline/Week 8 | 
| Dose and frequency of Rescue medication(Acetaminophen) |  | Baseline/Week 8 | 
| Number and proportion of subjects with adverse event |  | Baseline/Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregabalin sustained release tablet