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Recruitment status Terminated
Unique ID issued by UMIN UMIN000032412
Receipt No. R000036964
Scientific Title Multicenter clinical trial: treatment effect of lansoprazole on non-traumatic osteonecrosis of the femoral head
Date of disclosure of the study information 2018/04/27
Last modified on 2019/03/01

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Basic information
Public title Multicenter clinical trial: treatment effect of lansoprazole on non-traumatic osteonecrosis of the femoral head
Acronym Clinical trial for treatment effect of non-traumatic osteonecrosis of the femoral head
Scientific Title Multicenter clinical trial: treatment effect of lansoprazole on non-traumatic osteonecrosis of the femoral head
Scientific Title:Acronym Clinical trial for treatment effect of non-traumatic osteonecrosis of the femoral head
Region
Japan

Condition
Condition idiopathic osteonecrosis of the femoral head
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the treatment effect of lansoprazole in the patients with osteonecrosis of the femoral head compare with control group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes The reduction rate of non-traumatic osteonecrosis of the femoral head by MRI after 6 months and 1 year.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lansoprazole 30mg orally once a day for one year
Interventions/Control_2 No administration
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 1. Japanese patients diagnosed with non-traumatic osteonecrosis of the femoral head.
2. Osteonecrosis of the femoral head meets the diagnosis criteria for that condition and is Stage I or II and Type A-C2.
Key exclusion criteria 1. Patients with pain suggesting femoral head collapse (Stage III).
2. Patients underwent hip surgery.
3.Patients with alcohol-abuse or dementia
4. Past allergy to lansoprazole.
5. Patients treatment with atazanavir sulfate (Reyataz).
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ima Kosukegawa
Organization Sapporo Medical University
Division name Dept. of Orthopedic Surgery
Zip code
Address South 1 West 16 Chuo-Ku Sapporo 060-8543, Japan
TEL +81-011-611-2111(33330)
Email imakosukegawa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Ima Kosukegawa
Organization Sapporo Medical University
Division name Dept. of Orthopedic Surgery
Zip code
Address South 1 West 16 Chuo-Ku Sapporo 060-8543, Japan
TEL +81-11-611-2111(33330)
Homepage URL
Email imakosukegawa@gmail.com

Sponsor
Institute Sapporo Medical University Hospital
Institute
Department

Funding Source
Organization Dept. of Musculoskeletal Biomechanics and Surgical Devlopment, Sapporo Medical University
The Osaka Medical Research Foundation for Intractable Diseases
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
Email

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 札幌医科大学附属病院  Sapporo Medical University Hospital

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 27 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
2016 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 27 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036964

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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