UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016048 |
|---|---|
| Receipt number | R000018652 |
| Scientific Title | Evaluation of intravenous regional block with low- dose infliximab for patients with Complex Regional Pain Syndrome |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2014/12/24 16:24:33 |
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Basic information
Public title
Evaluation of intravenous regional block with low- dose infliximab for patients with Complex Regional Pain Syndrome
Acronym
Evaluation of intravenous regional block with low- dose IFX for patients with CRPS
Scientific Title
Evaluation of intravenous regional block with low- dose infliximab for patients with Complex Regional Pain Syndrome
Scientific Title:Acronym
Evaluation of intravenous regional block with low- dose IFX for patients with CRPS
Region
| Japan |
Condition
Condition
Patients with Complex Regional Pain Syndrome
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of intravenous regional block with low- dose infliximab for patients with Complex Regional Pain Syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity
Key secondary outcomes
1 Edema
2 Serum concentration of TNF-alpha
3 Allodynia
4 Skin color change
5 Skin temperature change
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
| Medicine |
Interventions/Control_1
Intravenous regional sympathetic nerve block with low-dose infliximab
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. In-patient aged over 20 years old of Department Anesthesiology in Fukuoka University Hospital
2. Patients meet the diagnostic criteria for CRPS proposed by a working group in Ministry of Health, Labour, and Welfare.
3. Edema of diseased limb
4. Patients have unilateral diseased limb.
5. Patients meet all screening criteria for tuberculosis.
No past history of latent or active tuberculosis
No sign and symptom of active tuberculosis
Negative results of T-spot or TB skin test
No sign of active or old tuberculosis on Chest X-ray
6. Patients meet screening criteria for hepatitis.
Negative HCV antibody, HBs antigen or HBc antibody test
(HBV DNA not detected).
Key exclusion criteria
1. The following laboratory data
Hb<8.5g/microliter
WBC<3.5*1000cells/microliter Neutrophil<1.0*1000cells/microliter
PLT<5*10000cells/microliter
ALT or AST>1.5*ULN
Total Bilirubin>ULN
Cr>=2.0mg/dL
(NT-pro BNP>=125pg/ml)
2. Patients have severe, progressive or uncontrolled kidney disease, liver disease, skin disease, blood disease, digestive disease, endocrine disease, lung disease, cardiac disease, or neurological disease.
3. Patients had been hospitalized within 3 months for cardiac event(myocardial infarction or unstable angina), stroke or TIA.
4. Patients had severe infection within 2 months.
5. Patients have congestive heart failure in NYHA class 2 to 4.
6. Patients had relapse or progressive infectious disease including chronic renal infection, chronic chest infectious disease or urinary tract infection.
Patients have past history of open drainage wound or ulcer.
7. Abnormal finding of interstitial pneumonia, tuberculosis, or other diseases on chest X-ray within 3 months
8. Past history of demyelinating disease including multiple sclerosis or optic neuritis
9. Patients have past history of gastrointestinal perforation or have active diverticulitis.
10. Patients had non-tuberculous mycobacterial infection or opportunistic infection within 6 months.
11. Hepatitis C positive
12. Hepatitis B positive
13. Patients have malignant neoplasm or had it within 5 years
14. Pregnant or lactating mother
15. Patients have steroid medication.
16. Investigator considers that the enrollment in this study is not benefit for the patient or intravenous regional sympathetic nerve blocking is impossible for the patient.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiho Shibata |
Organization
Fukuoka University Hospital
Division name
Department of Anesthesiology
Zip code
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
shibatas@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiho Shibata |
Organization
Fukuoka University Hospital
Division name
Department of Anesthesiology
Zip code
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
Homepage URL
shibatas@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | 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 | 12 | Month | 24 | Day |
Last modified on
| 2014 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018652
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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