Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

Not Applicable

Terminated

• Conditions: Pain, Neuropathic
• Interventions: Drug: Pregabalin 75mg bid; Drug: Pregabalin 25mg, 50mg

• Registration Number: NCT03691038
• Lead Sponsor: Kangbuk Samsung Hospital

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

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Study Start: 2018-10-10
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin 75mg bid	Pregabalin 75mg bid	The patients who were prescribed according to the conventional flexible dose regimen
pregabalin 25mg,50mg	Pregabalin 25mg, 50mg	The patients who were prescribed according to the new flexible dose regimen.

Primary Outcome Measures

Name	Time	Method
discontinuation of medication	After 7 weeks of prescription	the portion of patients discontinuing medication

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of