Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

Study Overview
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Brief Summary
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The purpose of this study is to propose a new flexible dose regimen starting from 75mg using the low dose pregabalin 25 mg and 50 mg comparing the side effect and compliance with the conventional flexible dose regimen staring from 150mg using the pregabalin 75mg.

Detailed Description
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Pregabalin has been shown to be effective as a first-line medication for neuropathic pain but it appears to have several side effects such as dizziness, drowsiness, and edema, which lowers compliance with medications. A way to reduce side effects is the flexible dose regimen, which reaches the target dose to treat the drug. The proposed flexible dose regimen is a regimen that begins with twice the prevalence of 75 mg. However, dizziness is the most common side effect up to 20% in conventional flexible dose regimen. Therefore, the aim of this study was to propose a new flexible regimen starting at a dose less than the existing dose and to compare compliance with pregabaline according to both methods

Official Title
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Comparison of Conventional Flexible Dose Regimen of Pregabalin and New Flexible Dose Regimen of Pregabalin Using Low Dose: A Randomized Controlled Trial

Conditions
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Pain, Neuropathic

Intervention / Treatment
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* Drug: Pregabalin 75mg bid
* Drug: Pregabalin 25mg, 50mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain score NRS ≥3 Patients complaining of neuropathic pain (except neuropathic pain due to chemotherapy) Adult patients aged 19 to 85 years Patients who pre-agreed to the study Exclusion Criteria: Patients complaining of severe pain (NRS ≥ 8) Creatinine clearance of <30 mL / min, the liver was more than 3 times normal Patients complaining of dizziness, patients with definite orthostatic hypotension Pregnant or lactating patients Patients who previously experienced side effects after administration pregabalin.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregabalin 75mg bid<br>The patients who were prescribed according to the conventional flexible dose regimen | Drug: Pregabalin 75mg bid<br>* Through the study period, Incremental protocol follows the conventional dose regimen starting pregabaline 75mg bid.<br>* Other names: Conventional regimen;|
| Experimental: pregabalin 25mg,50mg<br>The patients who were prescribed according to the new flexible dose regimen. | Drug: Pregabalin 25mg, 50mg<br>* Through the study period, Incremental protocol follows the new dose regimen starting pregabalin 25mg, 50mg<br>* Other names: New regimen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discontinuation of medication | the portion of patients discontinuing medication | After 7 weeks of prescription |