Unique ID issued by UMIN | UMIN000022397 |
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Receipt number | R000025620 |
Scientific Title | Clinical trial of efficacy and safety as a pilot study in pachydermoperiostosis |
Date of disclosure of the study information | 2016/05/21 |
Last modified on | 2017/11/27 12:46:19 |
Clinical trial of efficacy and safety as a pilot study in pachydermoperiostosis
A pilot study in PDP
Clinical trial of efficacy and safety as a pilot study in pachydermoperiostosis
A pilot study in PDP
Japan |
pachydermoperiostosis
Gastroenterology | Endocrinology and Metabolism | Hematology and clinical oncology |
Nephrology | Clinical immunology | Gastrointestinal surgery |
Pediatrics | Dermatology | Orthopedics |
Plastic surgery | Adult | Child |
Others
NO
The purpose of the study is to determine an efficacy and safety of Medicine A to prevent progression in pachydermia, arthropathy, and urinary contents of prostaglangin E2 of pachydermoperisotosis.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
clinical symptoms and signs
serum/urinary PGE2 content
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
1
Treatment
Medicine |
Medicine A 200 mg, twice daily, for 1 year
20 | years-old | <= |
Not applicable |
Male and Female
(1)A patient having clinical triad and excluded the following conditions: secondary hypertrophic osteoarthropathy, systemic bone diseases, acromegaly, Graves' disease-associated osteoarthropathy (thyroid acropachy, EMO syndrome)
(2)A patient who was found to have gene mutations in the HPGD or SLCO2A1 gene
(3)A patient who MR imaging in brain and legs and X-ray photograph in extremities were taken.
Patients who met the following conditions were excluded:
(1)allergy to Medicine A,
(2)history of asthma,
(3)history of gastrointestinal ulcer or bleeding,
(4)renal diseases (serum creatinine concentration more than 1.2 mg/dl, including having a history of dialysis),
(5)liver dysfunction (serum alanine or aspartate transaminase concentrations more than 3 times the upper limit of normal range),
(6)heart failure or myocardial infarction,
(7)body weight less than 40 kg.
3
1st name | |
Middle name | |
Last name | Hironori Niizeki |
National Center for Child Health and Development
Division of Dermatology, Department of Surgical Specialties
2-10-1, Okura, Setagaya-ku, Tokyo, Japan
+81-3-3416-0181
niizeki-h@ncchd.go.jp
1st name | |
Middle name | |
Last name | Mayumi Sako |
National Center for Child Health and Development
Division for Clinical Trials
2-10-1, Okura, Setagaya-ku, Tokyo, Japan
+81-3-3416-0181
sako-m@ncchd.go.jp
National Center for Child Health and Development
National Center for Child Health and Development
Other
Japan
NO
国立成育医療研究センター(東京都)
2016 | Year | 05 | Month | 21 | Day |
Unpublished
No longer recruiting
2016 | Year | 01 | Month | 18 | Day |
2016 | Year | 01 | Month | 18 | Day |
2017 | Year | 05 | Month | 11 | Day |
2017 | Year | 09 | Month | 21 | Day |
2016 | Year | 05 | Month | 21 | Day |
2017 | Year | 11 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025620
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