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Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

Primary Purpose

Pain, Neuropathic

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pregabalin 75mg bid
Pregabalin 25mg, 50mg
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Neuropathic

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kangbuk Samsung Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pregabalin 75mg bid

pregabalin 25mg,50mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

discontinuation of medication
the portion of patients discontinuing medication

Secondary Outcome Measures

Full Information

First Posted
September 28, 2018
Last Updated
September 2, 2020
Sponsor
Kangbuk Samsung Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03691038
Brief Title
Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin
Official Title
Comparison of Conventional Flexible Dose Regimen of Pregabalin and New Flexible Dose Regimen of Pregabalin Using Low Dose: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Participants couldn't be enrolled due to complain of frequent visit.
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin 75mg bid
Arm Type
Active Comparator
Arm Description
The patients who were prescribed according to the conventional flexible dose regimen
Arm Title
pregabalin 25mg,50mg
Arm Type
Experimental
Arm Description
The patients who were prescribed according to the new flexible dose regimen.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 75mg bid
Other Intervention Name(s)
Conventional regimen
Intervention Description
Through the study period, Incremental protocol follows the conventional dose regimen starting pregabaline 75mg bid.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 25mg, 50mg
Other Intervention Name(s)
New regimen
Intervention Description
Through the study period, Incremental protocol follows the new dose regimen starting pregabalin 25mg, 50mg
Primary Outcome Measure Information:
Title
discontinuation of medication
Description
the portion of patients discontinuing medication
Time Frame
After 7 weeks of prescription

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Hyun Lee, MD
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

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