UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007466 |
|---|---|
| Receipt number | R000008802 |
| Scientific Title | The diffuse sclerosing osteomyelitis of the mandible treated by pamidronate administration |
| Date of disclosure of the study information | 2012/03/09 |
| Last modified on | 2012/03/07 17:47:37 |
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Basic information
Public title
The diffuse sclerosing osteomyelitis of the mandible treated by pamidronate administration
Acronym
The diffuse sclerosing osteomyelitis of the mandible treated by pamidronate administration
Scientific Title
The diffuse sclerosing osteomyelitis of the mandible treated by pamidronate administration
Scientific Title:Acronym
The diffuse sclerosing osteomyelitis of the mandible treated by pamidronate administration
Region
| Japan |
Condition
Condition
chronic diffuse sclerosing osteomyelitis of the mandible
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination about the effectiveness of the pamidronate for the chronic diffuse sclerosing osteomyelitis of the mandible
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the pain scale every two weeks and confirm the change of the bone with the CT image three months later
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Injection of 30mg of pamidronate per once
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The case of ineffective against standard treatment
Key exclusion criteria
The case of effective against standard treatment
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Izumi YOSHITOMI |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Clinical Oral Oncology
Zip code
Address
1-7-1Sakamoto Nagasaki Japan
TEL
095-819-7699
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Izumi YOSHITOMI |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Clinical Oral Oncology
Zip code
Address
TEL
095-819-7699
Homepage URL
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences Department of Clinical Oral Oncology
Institute
Department
Personal name
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
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
| 2012 | Year | 03 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 07 | Day |
Last modified on
| 2012 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008802
