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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023254
Receipt No. R000025394
Scientific Title PhaseI/II prospective multi-center clinical trial of intra-arterial infusion of imipenem/cilastatin sodium particle for type1 complex regional pain syndrome in forward arm and hand
Date of disclosure of the study information 2016/07/25
Last modified on 2016/07/20

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Basic information
Public title PhaseI/II prospective multi-center clinical trial of intra-arterial infusion of imipenem/cilastatin sodium particle for type1 complex regional pain syndrome in forward arm and hand
Acronym PhaseI/II study of intra-arterial infusion for CRPS1 in forward arm and hand
Scientific Title PhaseI/II prospective multi-center clinical trial of intra-arterial infusion of imipenem/cilastatin sodium particle for type1 complex regional pain syndrome in forward arm and hand
Scientific Title:Acronym PhaseI/II study of intra-arterial infusion for CRPS1 in forward arm and hand
Region
Japan

Condition
Condition Type1 complex regional pain syndrome in forward arm and hand
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the safety and effectiveness of intra-arterial infusion therapy for CRPS type1 occured in forward arm and hand
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Clinical response rate of pain relief at 4months after first treatment
Key secondary outcomes Complication profile and its grade
Change of BPI score
Change of VAS score
Grip power
Quantity and frequency of other treatments
Change of ROM
Change of Quick Dash score
Change of skin temperature

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
Maneuver
Interventions/Control_1 Intra-arterial infusion using Imipenem/cilastatin sodium suspension
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
80 years-old >
Gender Male and Female
Key inclusion criteria Type1 CRPS in forward arm and hand
with allodynia
BPI average >5
Key exclusion criteria passed more than 12months from onset
severe arteriosclerosis
HbA1C>8.5
the history of allergy to contrast enhance
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Okuno
Organization Edogawa Hospital
Division name Musculoskeletal Intervention Center
Zip code
Address 2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL 03-3673-1221
Email okuno@edogawa.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Okuno
Organization Edogawa Hospital
Division name Musculoskeletal Intervention Center
Zip code
Address 2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL 03-3673-1221
Homepage URL
Email okuno@edogawa.or.jp

Sponsor
Institute Edogawa Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 07 Month 25 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
Date of protocol fixation
2016 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 25 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
2016 Year 07 Month 20 Day
Last modified on
2016 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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