UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022397 |
|---|---|
| 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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical trial of efficacy and safety as a pilot study in pachydermoperiostosis
Acronym
A pilot study in PDP
Scientific Title
Clinical trial of efficacy and safety as a pilot study in pachydermoperiostosis
Scientific Title:Acronym
A pilot study in PDP
Region
| Japan |
Condition
Condition
pachydermoperiostosis
Classification by specialty
| Gastroenterology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Nephrology | Clinical immunology | Gastrointestinal surgery |
| Pediatrics | Dermatology | Orthopedics |
| Plastic surgery | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
clinical symptoms and signs
Key secondary outcomes
serum/urinary PGE2 content
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Medicine A 200 mg, twice daily, for 1 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(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.
Key exclusion criteria
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.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironori Niizeki |
Organization
National Center for Child Health and Development
Division name
Division of Dermatology, Department of Surgical Specialties
Zip code
Address
2-10-1, Okura, Setagaya-ku, Tokyo, Japan
TEL
+81-3-3416-0181
niizeki-h@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Sako |
Organization
National Center for Child Health and Development
Division name
Division for Clinical Trials
Zip code
Address
2-10-1, Okura, Setagaya-ku, Tokyo, Japan
TEL
+81-3-3416-0181
Homepage URL
sako-m@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 11 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 21 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 21 | Day |
Last modified on
| 2017 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025620
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
