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Trial record 22 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

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

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ClinicalTrials.gov Identifier: NCT02597257
Recruitment Status : Unknown
Verified November 2015 by Yong Chul Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 5, 2015
Last Update Posted : November 5, 2015
Sponsor:
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by (Responsible Party):
Yong Chul Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Postherpetic Neuralgia Diabetic Polyneuropathy Peripheral Neuropathy Drug: Lidocaine HCl Drug: Normal saline Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain: Randomized, Controlled, Comparative Study
Study Start Date : August 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Normal Saline
  • normal saline
  • total 250 ml
  • once a week
  • 4 times
Drug: Normal saline
Normal saline continuous infusion
Other Name: 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 Name: 183903BIJ, Lidocaine HCl inj. 2% DAEHAN PHARM. CO., LTD.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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]

  2. 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)

  3. 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

  4. 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)

  5. 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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02597257


Contacts
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Contact: Yong Chul Kim +82-2-2072-3289 pain@snu.ac.kr

Locations
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Korea, Republic of
Yong Chul Kim Recruiting
Seoul, Korea, Republic of
Contact: Yong Chul Kim, PhD    +82-2-2072-3289    pain@snu.ac.kr   
Sub-Investigator: Jee Youn Moon, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Food and Drug Safety, Korea
Investigators
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Principal Investigator: Yong Chul Kim, PhD Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yong Chul Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02597257     History of Changes
Other Study ID Numbers: 1720150047
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: November 2015
Keywords provided by Yong Chul Kim, Seoul National University Hospital:
Lidocaine infusion therapy
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Neuralgia
Peripheral Nervous System Diseases
Polyneuropathies
Neuralgia, Postherpetic
Diabetic Neuropathies
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action