UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015214 |
|---|---|
| Receipt number | R000017691 |
| Scientific Title | Controlling Herpes Zoster-Associated Pain Using EpiStim Catheter, a Specific Drug Delivery Device :A pilot study |
| Date of disclosure of the study information | 2014/09/21 |
| Last modified on | 2014/09/20 17:30:27 |
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Basic information
Public title
Controlling Herpes Zoster-Associated Pain Using EpiStim Catheter, a Specific Drug Delivery Device :A pilot study
Acronym
Controlling Herpes Zoster-Associated Pain Using EpiStim Catheter :A pilot study
Scientific Title
Controlling Herpes Zoster-Associated Pain Using EpiStim Catheter, a Specific Drug Delivery Device :A pilot study
Scientific Title:Acronym
Controlling Herpes Zoster-Associated Pain Using EpiStim Catheter :A pilot study
Region
| Asia(except Japan) |
Condition
Condition
herpes zoster patient
Classification by specialty
| Medicine in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether Epistim catheter, a specific drug delivery device, is effective for herpes zoster patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relief of VAS(visual analog pain scale) score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1. Affected spinal segment through electrical stimulation can be found using Epistim
2. We inject the drug to lesion precisely
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. herpetic eruption accompanied skin rash with multiple grouped vesicle of less than 1 month duration
or
2. chronic herpes zoster-associated pain patient more than 1 month duration
Key exclusion criteria
1) For those suffering other cancer
2) For those suffering meningitis or pneumonia
3) Pregnant or Lactating women
4) For those suffering inflammation
5) For those suffering liver dysfunction
6) For those suffering myelo -suppression
7) For those suffering kidney dysfunction
8) For those having bleeding tendency or undertaking anti-coagulation or anti-platelet therapy
9) For those suffering psychiatric disorder
10) For those suffering uncontrolled Diabetes mellius
11) For those who have history of cardiac infarction in the last three months, or suffering angina pectoralis
12) For those having history of Idiopathic pulmonary fibrosis or interstitial pneumonia
13) For those who refuse
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sang sik Choi |
Organization
Korea University Guro Hospital
Division name
Department of Anesthesiology and Pain medicine
Zip code
Address
Korea University Guro Hospital, Guro 2-dong, Guro-gu, Seoul, Republic of Korea 152-703
TEL
82-10-8270-3725
clonidine@empas.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jung eun Kim |
Organization
Korea University Guro Hospital
Division name
Department of Anesthesiology and Pain medicine
Zip code
Address
Korea University Guro Hospital, Guro 2-dong, Guro-gu, Seoul, Republic of Korea 152-703
TEL
82-10-7271-5391
Homepage URL
geri200@gmail.com
Sponsor or person
Institute
Korea University Guro Hospital, Department of Anesthesiology and Pain medicine
Institute
Department
Personal name
Funding Source
Organization
Korea University Guro Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 20 | Day |
Last modified on
| 2014 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017691
