Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

Pain, Neuropathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03691038
• Other study ID #: 2018-08-013
• Status: Terminated
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: September 2020
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Pain, Neuropathic

Intervention

Drug:
• Pregabalin 75mg bid
Through the study period, Incremental protocol follows the conventional dose regimen starting pregabaline 75mg bid.
• Pregabalin 25mg, 50mg
Through the study period, Incremental protocol follows the new dose regimen starting pregabalin 25mg, 50mg

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	discontinuation of medication	the portion of patients discontinuing medication	After 7 weeks of prescription