Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

NCT ID: NCT03691038

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2019-10-30

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

Conditions

Pain, Neuropathic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pregabalin 75mg bid

The patients who were prescribed according to the conventional flexible dose regimen

Group Type: ACTIVE_COMPARATOR

Pregabalin 75mg bid

Intervention Type: DRUG

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

pregabalin 25mg,50mg

The patients who were prescribed according to the new flexible dose regimen.

Group Type: EXPERIMENTAL

Pregabalin 25mg, 50mg

Intervention Type: DRUG

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

Interventions

Pregabalin 75mg bid

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

Intervention Type: DRUG

Pregabalin 25mg, 50mg

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

Intervention Type: DRUG

Other Intervention Names

Conventional regimen; New regimen

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kangbuk Samsung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyoung-Ho Ryu, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung Hyun Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

Kangbuk Samsung Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2018-08-013

Identifier Type: -

Identifier Source: org_study_id