Postherpetic NeuralgiaPhase 2NCT02597257
Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain
A Phase 2 study testing Lidocaine HCl and Normal saline in people with Postherpetic Neuralgia and Diabetic Polyneuropathy, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Postherpetic Neuralgia, Diabetic Polyneuropathy, Peripheral Neuropathy
- What is being tested?
- Lidocaine HCl and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postherpetic neuralgia, diabetic polyneuropathy, peripheral neuropathy
- NRS score > 4
- stable oral medication during the 1 month trial period
- volunteers with informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yong Chul Kim
Seoul
Yong Chul Kim, PhD, +82-2-2072-3289, pain@snu.ac.kr
Jee Youn Moon, PhD
About this study
Official title: 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.
Read the detailed description
The investigators expect pain improvement after treatment with 3 mg/kg of lidocaine, continuously infused in normal saline 250 ml.
- Being tested
- Lidocaine HCl, Normal saline
- Keywords
- Lidocaine infusion therapy
- Medical subject headings
- Neuralgia, Postherpetic, Diabetic Neuropathies, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HClDrug
Also called 183903BIJ, Lidocaine HCl inj. 2% DAEHAN PHARM. CO., LTD.
lidocaine continuous infusion
Normal salineDrug
Also called 228714BIJ, ISOTONIC SODIUM CHLORIDE DAEHAN PHARM. CO., LTD.
Normal saline continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | * normal saline
* total 250 ml
* once a week
* 4 times Receives: Drug: Normal saline |
| Lidocaine HCl | Active comparator | * lidocaine 3 mg/kg mixed in normal saline
* total 250 ml
* once a week
* 4 times Receives: Drug: Lidocaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
11-point Numeric Rating Scale
Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain
Measured: 1 week after the end of intervention
Secondary outcomes (5)
Brief Pain Inventory Short Form
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]
Measured: at the end of intervention and 4 weeks after the end of intervention
Shot Form McGill Pain Questionnaire
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)
Measured: at the end of intervention and 4 weeks after the end of intervention
Patient Global Impression of Change
7-point scale from very much improved to very much worse
Measured: 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
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)
Measured: through the study completion (7 weeks)
11-point Numeric Rating Scale
Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain
Measured: 4 weeks after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Responsible party
- Principal investigator, Yong Chul Kim, Seoul National University Hospital
- Investigators
- Yong Chul Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597257
- Sponsor's protocol ID
- 1720150047
- Status last verified
- Nov 2015
- First submitted
- 18 Sep 2015
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29381569
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain: Randomized, Controlled, Comparative Study
- ClinicalTrials.gov ID
- NCT02597257
- Acronym / sponsor ID
- 1720150047
- Keywords
- Lidocaine infusion therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators expect pain improvement after treatment with 3 mg/kg of lidocaine, continuously infused in normal saline 250 ml.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: Normal saline* normal saline * total 250 ml * once a week * 4 times |
| Lidocaine HCl | Active comparator | Drug: Lidocaine HCl* lidocaine 3 mg/kg mixed in normal saline * total 250 ml * once a week * 4 times |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- postherpetic neuralgia, diabetic polyneuropathy, peripheral neuropathy
- NRS score > 4
- stable oral medication during the 1 month trial period
- volunteers with informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine HClAlso: 183903BIJ, Lidocaine HCl inj. 2% DAEHAN PHARM. CO., LTD.lidocaine continuous infusion | Drug | Lidocaine HCl |
| Normal salineAlso: 228714BIJ, ISOTONIC SODIUM CHLORIDE DAEHAN PHARM. CO., LTD.Normal saline continuous infusion | Drug | Normal Saline |
Primary outcome
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
5 secondary outcomes
Brief Pain Inventory Short Form
Time frame: 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
Patient Global Impression of Change
Time frame: 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)
11-point Numeric Rating Scale
Time frame: 4 weeks after the end of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Derived from this study: PubMed 29381569Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Chul Kim, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine HCl and Normal saline in people with Postherpetic Neuralgia and Diabetic Polyneuropathy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Chul Kim (+82-2-2072-3289, pain@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11-point Numeric Rating Scale (time frame: 1 week after the end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.