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Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

K

Kangbuk Samsung Hospital

Status

Terminated

Conditions

Pain, Neuropathic

Treatments

Drug: Pregabalin 25mg, 50mg
Drug: Pregabalin 75mg bid

Study type

Interventional

Funder types

Other

Identifiers

NCT03691038
2018-08-013

Details and patient eligibility

About

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.

Full 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

Enrollment

10 patients

Sex

All

Ages

19 to 85 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

10 participants in 2 patient groups

Pregabalin 75mg bid
Active Comparator group
Description:
The patients who were prescribed according to the conventional flexible dose regimen
Treatment:
Drug: Pregabalin 75mg bid
pregabalin 25mg,50mg
Experimental group
Description:
The patients who were prescribed according to the new flexible dose regimen.
Treatment:
Drug: Pregabalin 25mg, 50mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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