UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004655 |
|---|---|
| Receipt number | R000005543 |
| Scientific Title | Bone regenerative therapy by octacalcium phosphate (OCP) collagen composites |
| Date of disclosure of the study information | 2010/12/11 |
| Last modified on | 2013/06/05 11:36:21 |
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Basic information
Public title
Bone regenerative therapy by octacalcium phosphate (OCP) collagen composites
Acronym
Bone regenerative therapy by octacalcium phosphate (OCP) collagen composites
Scientific Title
Bone regenerative therapy by octacalcium phosphate (OCP) collagen composites
Scientific Title:Acronym
Bone regenerative therapy by octacalcium phosphate (OCP) collagen composites
Region
| Japan |
Condition
Condition
Tooth extraction socket, Cyst hole
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety assessment by clinical examination and adverse event
Key secondary outcomes
Radiographic examination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implantation of OCP collagen composites into bone defects affected with cystectomy or tooth extraction
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inpatient/Outpatient: no specification
Disease/ Severity: A cyst below 5 cm in longest diameters of radiographic examination
Affected period: no specification
Treatment period: no specification
Patients who can provide written informed consent
Key exclusion criteria
Patient suffering severe hepatopathy, renal disorders, and heart disease who would affect safety evaluation of this trial
Patient who has an allergy drug
Patient who is pregnant, possibly pregnant, nursing or considering pregnancy Patient who participated other clinical trial program within 3 months prior to the study entry
Others, patient who is unfit for the study as determined by the principal investigator or sub-investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji KAMAKURA |
Organization
Tohoku University
Division name
Bone Regenerative Engineering Laboratory, Graduate School of Biomedical Engineering
Zip code
Address
2-1 Seiryo-Machi, Aoba-Ku, Sendai 980-8574, JAPAN
TEL
022-717-8235
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji KAMAKURA |
Organization
Tohoku University
Division name
Bone Regenerative Engineering Laboratory, Graduate School of Biomedical Engineering
Zip code
Address
2-1 Seiryo-Machi, Aoba-Ku, Sendai 980-8574, JAPAN
TEL
022-717-8235
Homepage URL
kamakura@bme.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 11 | 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
| 2010 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 02 | Day |
Last modified on
| 2013 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005543
