UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter clinical trial: treatment effect of lansoprazole on non-traumatic osteonecrosis of the femoral head
Title of the study (Brief title)	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	Ima Kosukegawa
Organization	Sapporo Medical University
Division name	Dept. of Orthopedic Surgery
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	Ima Kosukegawa
Organization	Sapporo Medical University
Division name	Dept. of Orthopedic Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 05 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000036964