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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000019348 |
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Date of registration:
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14/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Approved calcium channel blocker in the treatment of fibrodysplasia ossificans progressiva (FOP)
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Scientific title:
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Approved calcium channel blocker in the treatment of fibrodysplasia ossificans progressiva (FOP) - Perhexiline maleate treatment for FOP |
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Date of first enrolment:
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2010/07/01 |
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Target sample size:
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5 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022377 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase I,II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hiroshi Kitoh |
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Address:
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65 Tsurumai, Nagoya, Aichi
Japan |
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Telephone:
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052-741-2111 |
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Email:
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hkitoh@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya University Graduate School of Medicine Orthopaedic Surgery |
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Name:
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Hiroshi Kitoh |
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Address:
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65 Tsurumai, Nagoya, Aichi
Japan |
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Telephone:
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052-741-2111 |
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Email:
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hkitoh@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya University Graduate School of Medicine Orthopaedic Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Skeletally immature patients
Age minimum:
15years-old
Age maximum:
65years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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fibrodysplasia ossificans progressiva
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Intervention(s)
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oral administration of perhexiline maleate for one year
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Primary Outcome(s)
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Total bone volume before the intervention, at the end of medication, and at the end of the study
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Secondary Outcome(s)
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serum alkaline phosphatase and osteocalsin concentration
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Source(s) of Monetary Support
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Ministry of Health, Labour and Welfare
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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