UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019348 |
|---|---|
| Receipt number | R000022377 |
| Scientific Title | Approved calcium channel blocker in the treatment of fibrodysplasia ossificans progressiva (FOP) |
| Date of disclosure of the study information | 2015/10/14 |
| Last modified on | 2015/10/14 19:30:20 |
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Basic information
Public title
Approved calcium channel blocker in the treatment of fibrodysplasia ossificans progressiva (FOP)
Acronym
Perhexiline maleate treatment for FOP
Scientific Title
Approved calcium channel blocker in the treatment of fibrodysplasia ossificans progressiva (FOP)
Scientific Title:Acronym
Perhexiline maleate treatment for FOP
Region
| Japan |
Condition
Condition
fibrodysplasia ossificans progressiva
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of perhexiline maleate in the treatment of fibrodysplasia ossificans progressiva
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Total bone volume before the intervention, at the end of medication, and at the end of the study
Key secondary outcomes
serum alkaline phosphatase and osteocalsin concentration
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
| Medicine |
Interventions/Control_1
oral administration of perhexiline maleate for one year
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who presents classic features of FOP, and who have R206H mutation in the ACVR1/ALK2 gene.
Key exclusion criteria
Skeletally immature patients
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitoh |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
65 Tsurumai, Nagoya, Aichi
TEL
052-741-2111
hkitoh@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitoh |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
65 Tsurumai, Nagoya, Aichi
TEL
052-741-2111
Homepage URL
hkitoh@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding 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
| 2015 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | 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
| 2015 | Year | 10 | Month | 14 | Day |
Last modified on
| 2015 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022377
