Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain

November 3, 2015 updated by: Yong Chul Kim, Seoul National University Hospital

Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain: Randomized, Controlled, Comparative Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators expect pain improvement after treatment with 3 mg/kg of lidocaine, continuously infused in normal saline 250 ml.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yong Chul Kim
  • Phone Number: +82-2-2072-3289
  • Email: pain@snu.ac.kr

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yong Chul Kim
        • Contact:
          • Yong Chul Kim, PhD
          • Phone Number: +82-2-2072-3289
          • Email: pain@snu.ac.kr
        • Sub-Investigator:
          • Jee Youn Moon, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Normal Saline
  • normal saline
  • total 250 ml
  • once a week
  • 4 times
Drug: Normal saline
Normal saline continuous infusion
Other Names:
  • 228714BIJ, ISOTONIC SODIUM CHLORIDE DAEHAN PHARM. CO., LTD.
Active Comparator: Lidocaine HCl
  • lidocaine 3 mg/kg mixed in normal saline
  • total 250 ml
  • once a week
  • 4 times
Drug: Lidocaine HCl
lidocaine continuous infusion
Other Names:
  • 183903BIJ, Lidocaine HCl inj. 2% DAEHAN PHARM. CO., LTD.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
11-point Numeric Rating Scale
Time Frame: 1 week after the end of intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory Short Form
Time Frame: at the end of intervention and 4 weeks after the end of intervention
measurements of pain intensity, functionality, and impact of pain, rated on an 11-point Numerical Rating Scale (NRS) [0=no pain to 10=worst possible pain]
at the end of intervention and 4 weeks after the end of intervention
Shot Form McGill Pain Questionnaire
Time Frame: at the end of intervention and 4 weeks after the end of intervention
15 pain descriptors ranked on a 4-stage intensity scale, the Present Pain Intensity index ranked on a 6-stage intensity and VAS (100-mm scale)
at the end of intervention and 4 weeks after the end of intervention
Patient Global Impression of Change
Time Frame: at the end of intervention and 4 weeks after the end of intervention
7-point scale from very much improved to very much worse
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
Time Frame: through the study completion (7 weeks)
AEs, laboratory values, vital signs, 12-lead ECG, finding from physical examination The intensity of AEs was graded according to the NCI common terminology criteria for adverse events v 4.0 on five point scale (grade 1 to 5: mild, moderate, severe, life-threatening and Death)
through the study completion (7 weeks)
11-point Numeric Rating Scale
Time Frame: 4 weeks after the end of intervention
Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain
4 weeks after the end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Food and Drug Safety, Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yong Chul Kim, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1720150047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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