UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000027257
Receipt No. R000031223
Scientific Title The assessment of synergistic effect of STFX and a-PDT to MRONJ
Date of disclosure of the study information 2017/05/08
Last modified on 2019/06/02 (Ver. 5)

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Basic information
Public title The assessment of synergistic effect of STFX and a-PDT to MRONJ
Acronym synergistic effect of STFX and a-PDT to MRONJ
Scientific Title The assessment of synergistic effect of STFX and a-PDT to MRONJ
Scientific Title:Acronym synergistic effect of STFX and a-PDT to MRONJ
Region
Japan

Condition
Condition MRONJ
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the treatment effect of STFX and a-PDT for MRONJ.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the term until improvement of symptoms of infection.
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 STFX 100mg/day 4weeks
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 MRONJ
Key exclusion criteria hepatic or kidney disoeder
allergy
pregnant
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name Seigo
Middle name
Last name Ohba
Organization Nagasaki University
Division name Regenerative Oral Surgery
Zip code 852-8588
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7704
Email sohba@nagasaki-u.ac.jp

Public contact
1st name of contact person
1st name Seigo
Middle name
Last name Ohba
Organization Nagasaki Uiversity
Division name Regenerative Oral Surgery
Zip code 852-8588
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7704
Homepage URL
Email sohba@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
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 Nagasaki University
Address 1-7-1 Sakamoto, Nagasaki
Tel 096-819-7704
Email sohba@nagasaki-u.ac.jp

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
2017 Year 05 Month 08 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 12
Results 
Only 2 patients who underwent this protocol treatment, were followed up and the progress of both of them was good.
Results date posted
2019 Year 06 Month 02 Day
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
2015 Year 07 Month 01 Day
Date of IRB
2015 Year 07 Month 01 Day
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information These 2 case reports would be published in near future.

Management information
Registered date
2017 Year 05 Month 06 Day
Last modified on
2019 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031223