UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018838 |
|---|---|
| Receipt number | R000021788 |
| Scientific Title | The effect of Lansoprazole in the prevention of osteonecrosis of the femoral head in patients with immune diseases treated corticosteroid |
| Date of disclosure of the study information | 2015/08/28 |
| Last modified on | 2019/09/08 10:21:42 |
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Basic information
Public title
The effect of Lansoprazole in the prevention of osteonecrosis of the femoral head in patients with immune diseases treated corticosteroid
Acronym
The effect of Lansoprazole in the prevention of osteonecrosis of the femoral head in patients with immune diseases treated corticosteroid
Scientific Title
The effect of Lansoprazole in the prevention of osteonecrosis of the femoral head in patients with immune diseases treated corticosteroid
Scientific Title:Acronym
The effect of Lansoprazole in the prevention of osteonecrosis of the femoral head in patients with immune diseases treated corticosteroid
Region
| Japan |
Condition
Condition
non-traumatic osteonecrosis of the femoral head
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of non-traumatic osteonecrosis of the femoral head
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of prevention efficacy of Lansoprazole using MRI at 3 and 6 months after corticosteroid treatment.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Takepron intravenous 30mg intravenously a total of 10 times (once the night before corticosteroid treatment started, and thereafter twice a day). Subsequently, Takepron OD 30mg orally once a day for 23 days.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary orticosteroid dose of 35 mg/day or more.
Key exclusion criteria
Current ONFH; hip joint disease requiring surgery; alcohol-abuse; dementia; past allergy to LPZ; treatment with atazanavir sulfate.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ima Kosukegawa |
Organization
Sapporo Medical University
Division name
Department of Orthopedic Surgery
Zip code
Address
S1W17, Chuo-ku, Sapporo, Hokkaido
TEL
+81116112111
imakosukegawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ima Kosukegawa |
Organization
Sapporo Medical University
Division name
Department of Orthopedic Surgery
Zip code
Address
S1W17, Chuo-ku, Sapporo, Hokkaido
TEL
+81116112111
Homepage URL
imakosukegawa@gmail.com
Sponsor or person
Institute
Sapporo Medical University hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Musculoskeletal Biomechanics and Surgical Development, Sapporo Medical University
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
| 2015 | Year | 08 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 28 | Day |
Last modified on
| 2019 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021788
