NCT02597257

Brief Summary

The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

September 18, 2015

Last Update Submit

November 3, 2015

Conditions

Postherpetic NeuralgiaDiabetic PolyneuropathyPeripheral Neuropathy

Keywords

Lidocaine infusion therapy

Outcome Measures

Primary Outcomes (1)

  • 11-point Numeric Rating Scale

    Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain

    1 week after the end of intervention

Secondary Outcomes (5)

  • Brief Pain Inventory Short Form

    at the end of intervention and 4 weeks after the end of intervention

  • Shot Form McGill Pain Questionnaire

    at the end of intervention and 4 weeks after the end of intervention

  • Patient Global Impression of Change

    at the end of intervention and 4 weeks after the end of intervention

  • Number of patients with grade 3 through grade 5 adverse events that are related to study drug, graded according to NCI CTCAE version 4.0

    through the study completion (7 weeks)

  • 11-point Numeric Rating Scale

    4 weeks after the end of intervention

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

* normal saline * total 250 ml * once a week * 4 times

Drug: Normal saline

Lidocaine HCl

ACTIVE COMPARATOR

* lidocaine 3 mg/kg mixed in normal saline * total 250 ml * once a week * 4 times

Drug: Lidocaine HCl

Interventions

Lidocaine HClDRUG

lidocaine continuous infusion

Also known as: 183903BIJ, Lidocaine HCl inj. 2% DAEHAN PHARM. CO., LTD.
Lidocaine HCl
Normal salineDRUG

Normal saline continuous infusion

Also known as: 228714BIJ, ISOTONIC SODIUM CHLORIDE DAEHAN PHARM. CO., LTD.
Normal Saline

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postherpetic neuralgia, diabetic polyneuropathy, peripheral neuropathy
  • NRS score \> 4
  • stable oral medication during the 1 month trial period
  • volunteers with informed consent

You may not qualify if:

  • pregnancy, breastfeeding, possibility of pregnancy
  • pain from causes other than upper 3 indications
  • hypersensitivity to lidocaine or other local anesthetics
  • important disease of heart, kidney, liver or incurable disease that may affect the assessment of adverse effects, or may interfere with the completion of study
  • severe conduction block
  • history of other interventions that may affect the study
  • Enrollment in other clinical trials within 30 days
  • otherwise not suitable to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yong Chul Kim

Seoul, South Korea

RECRUITING

Related Publications (1)

  • Kim YC, Castaneda AM, Lee CS, Jin HS, Park KS, Moon JY. Efficacy and Safety of Lidocaine Infusion Treatment for Neuropathic Pain: A Randomized, Double-Blind, and Placebo-Controlled Study. Reg Anesth Pain Med. 2018 May;43(4):415-424. doi: 10.1097/AAP.0000000000000741.

    PMID: 29381569DERIVED

MeSH Terms

Conditions

Neuralgia, PostherpeticDiabetic NeuropathiesPeripheral Nervous System Diseases

Interventions

LidocaineLong-Term Synaptic DepressionSaline Solution

Condition Hierarchy (Ancestors)

NeuralgiaNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yong Chul Kim, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Chul Kim

CONTACT

+82-2-2072-3289pain@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2015

First Posted

November 5, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

KR(1)