NCT03691038

Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Kangbuk Samsung Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Pain, Neuropathic

Interventions

Type	Name	Description
DRUG	Pregabalin 75mg bid	Through the study period, Incremental protocol follows the conventional dose regimen starting pregabaline 75mg bid.
DRUG	Pregabalin 25mg, 50mg	Through the study period, Incremental protocol follows the new dose regimen starting pregabalin 25mg, 50mg

Timeline

• Start date: 2018-10-10
• Primary completion: 2019-10-30
• Completion: 2019-10-30
• First posted: 2018-10-01
• Last updated: 2020-09-04

Locations

1 site across 1 country: South Korea