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Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000032412
Date of registration:	27/04/2018
Prospective Registration:	No
Primary sponsor:	Sapporo Medical University Hospital
Public title:	Multicenter clinical trial: treatment effect of lansoprazole on non-traumatic osteonecrosis of the femoral head
Scientific title:	Multicenter clinical trial: treatment effect of lansoprazole on non-traumatic osteonecrosis of the femoral head - Clinical trial for treatment effect of non-traumatic osteonecrosis of the femoral head
Date of first enrolment:	2016/08/21
Target sample size:	100
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036964
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Phase II

Countries of recruitment
Japan

Contacts

Name:	Ima Kosukegawa
Address:	South 1 West 16 Chuo-Ku Sapporo 060-8543, Japan
Telephone:	+81-011-611-2111(33330)
Email:	imakosukegawa@gmail.com
Affiliation:	Sapporo Medical University Dept. of Orthopedic Surgery

Name:	Ima Kosukegawa
Address:	South 1 West 16 Chuo-Ku Sapporo 060-8543, Japan
Telephone:	+81-11-611-2111(33330)
Email:	imakosukegawa@gmail.com
Affiliation:	Sapporo Medical University Dept. of Orthopedic Surgery

Key inclusion & exclusion criteria

Inclusion criteria:
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).

Age minimum: 18years-old
Age maximum: 75years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

idiopathic osteonecrosis of the femoral head

Intervention(s)

Lansoprazole 30mg orally once a day for one year
No administration

Primary Outcome(s)

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

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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