Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

NCT03691038 | Terminated

• 1 other identifier: 2018-08-013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Neuropathic

Outcome Measures

Primary Outcomes (1)

• discontinuation of medication

  the portion of patients discontinuing medication

  After 7 weeks of prescription

Study Arms (2)

Pregabalin 75mg bid

ACTIVE COMPARATOR

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

Drug: Pregabalin 75mg bid

pregabalin 25mg,50mg

EXPERIMENTAL

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

Drug: Pregabalin 25mg, 50mg

Interventions

Pregabalin 75mg bid DRUG

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

Also known as: Conventional regimen

Pregabalin 75mg bid

Pregabalin 25mg, 50mg DRUG

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

Also known as: New regimen

pregabalin 25mg,50mg

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin; BID protein, human

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sung Hyun Lee, MD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 1, 2018
• Study Start: October 10, 2018
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)