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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03691038

Enrollment

Registered

2018-10-01

Start date

2018-10-10

Completion date

2019-10-30

Last updated

2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Neuropathic

Brief 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

Interventions

DRUGPregabalin 25mg, 50mg

Through the study period, Incremental protocol follows the new dose regimen starting pregabalin 25mg, 50mg

DRUGPregabalin 75mg bid

Through the study period, Incremental protocol follows the conventional dose regimen starting pregabaline 75mg bid.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
discontinuation of medication	After 7 weeks of prescription	the portion of patients discontinuing medication

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026