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Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691038
Recruitment Status : Terminated (Participants couldn't be enrolled due to complain of frequent visit.)
First Posted : October 1, 2018
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Kyoung-Ho Ryu, MD, Kangbuk Samsung Hospital

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.

Condition or disease Intervention/treatment Phase
Pain, Neuropathic Drug: Pregabalin 75mg bid Drug: Pregabalin 25mg, 50mg Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Conventional Flexible Dose Regimen of Pregabalin and New Flexible Dose Regimen of Pregabalin Using Low Dose: A Randomized Controlled Trial
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: Pregabalin 75mg bid
The patients who were prescribed according to the conventional flexible dose regimen
Drug: Pregabalin 75mg bid
Through the study period, Incremental protocol follows the conventional dose regimen starting pregabaline 75mg bid.
Other Name: Conventional regimen

Experimental: pregabalin 25mg,50mg
The patients who were prescribed according to the new flexible dose regimen.
Drug: Pregabalin 25mg, 50mg
Through the study period, Incremental protocol follows the new dose regimen starting pregabalin 25mg, 50mg
Other Name: New regimen




Primary Outcome Measures :
  1. discontinuation of medication [ Time Frame: After 7 weeks of prescription ]
    the portion of patients discontinuing medication



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691038


Locations
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Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Sponsors and Collaborators
Kangbuk Samsung Hospital
Investigators
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Principal Investigator: Sung Hyun Lee, MD Kangbuk Samsung Hospital
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Responsible Party: Kyoung-Ho Ryu, MD, Assistant Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT03691038    
Other Study ID Numbers: 2018-08-013
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs