UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation for efficacy and safety of Irsogladine maleate for oral lichen planus
Title of the study (Brief title)	Evaluation for efficacy of Irsogladine maleate for oral lichen planus
Region	Japan

Condition
Condition	oral lichen planus
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	efficacy and safety
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	pain area location
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	irsogladine maleate
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)patients with oral lichen planus 2)untreated patients 3)Patients who can discontinue use of any medication at least 2 weeks prior to admission to the study 4)outpatients 5)Signed informed consent forms are obtained by the patients
Key exclusion criteria	1)Contraindication toirsogladine maleate. 2)Pregnancy or women with suspected pregnancy. 3)Serious cardiac disease, serious hepatic disorder , renal disease. 4)The patients who could not be provided with informed consent. 5)Unsuitability for the trial based on clinical judgement.
Target sample size	40

Research contact person
Name of lead principal investigator	Yumiko OHBAYASHI
Organization	Kagawa University
Division name	Department of Oral and Maxillofacial Surgery, Faculty of Medicine
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture 761-0793, Japan
TEL	087-891-2227
Email

Public contact
Name of contact person	Yumiko OHBAYASHI
Organization	Kagawa University
Division name	Department of Oral and Maxillofacial Surgery, Faculty of Medicine
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture
TEL	087-891-2227
Homepage URL
Email	yumiko@med.kagawa-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Kagawa University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	香川大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 12 Day
Anticipated trial start date	2012 Year 06 Month 12 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 20 Day
Last modified on	2017 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010260