UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032281 |
|---|---|
| Receipt number | R000036812 |
| Scientific Title | Multi-center randomized controlled blind study of LC-4308 in Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed |
| Date of disclosure of the study information | 2018/04/17 |
| Last modified on | 2019/07/31 14:22:06 |
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Basic information
Public title
Multi-center randomized controlled blind study of LC-4308 in Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed
Acronym
Multi-center randomized controlled blind study of LC-4308
Scientific Title
Multi-center randomized controlled blind study of LC-4308 in Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed
Scientific Title:Acronym
Multi-center randomized controlled blind study of LC-4308
Region
| Japan |
Condition
Condition
Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate Safety and Efficacy of LC-4308 compared with Standard of care group for Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adhesion at locking plate removal
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
LC-4308 (Adhesion Barrier System)
Interventions/Control_2
Standard of care
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)Patients provided written informed consent
(2)Patients aged 20 years or older at the time of informed consent
(3)Patients who are diagnosed A2, A3, C1 or C2 by AO classification
(4)Patients who are able to keep splint for 1 week
(5)Patients who are scheduled to be removed locking plate
(6)Patients who are able to be tested according to the plan
(7)Patients who have surgery within 2 weeks after injury
Key exclusion criteria
(1)Patients with an open fracture in the target site
(2)Patients complicated by other site fractures which may influence the evaluation of end points
(3)Patients with the possibility of the rupture of tendon, main nerve, or blood vessels in the target site
(4)Patients with the possibility of the combination of Artificial bones
(5)Patients with the possibility of the placement of the locking plate beyond the watershed line
(6)Patients unable to follow the instruction of rehabilitation
(7)Patients who have limited range of motion of either one or both thumbs
(8)Patients with high risk of fracture from the continuous treatment of oral steroids
(9)Patients with serious Cardiovascular diseases, Liver diseases, Respiratory diseases, Malignancy or Immunodeficiency at registration
(10)Patients with a history of severe drug allergies
(11)Patients with a history of Biodegradable plastic allergies
(12)Uncontrollable Diabetes mellitus
(13)Patients with pregnancy or possible pregnancy, patients who are breast-feeding, and patients who cannot prevent pregnancy properly until locking plate removal after informed consent
(14)Patients with Rheumatoid arthritis
(15)Patients who are continuing to undergo or have not yet finished their tests or other clinical studies under informed consent
(16)Others, patients who are judged as inadequately by principal investigator or sub-investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Matsushita |
Organization
Kawasaki Municipal Tama Hospital
Division name
Orthopedics
Zip code
Address
1-30-37 Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa-ken
TEL
044-933-8111
k2matsu@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Namoto |
Organization
JMS CO.,LTD.
Division name
Clinical Research Section Regulatory Affairs and Quality Assurance Division
Zip code
Address
12-17 Kako-machi, Naka-ku, Hiroshima-shi, Hiroshima-ken
TEL
082-243-6033
Homepage URL
s-namoto@jms.cc
Sponsor or person
Institute
JMS CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
JMS CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2018 | Year | 04 | Month | 17 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 17 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036812
