UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A trial on the effects of gastric-acid inhibiting drug on treatment of sleep bruxism
Title of the study (Brief title)	A trial on the effects of gastric-acid inhibiting drug on treatment of sleep bruxism
Region	Japan

Condition
Condition	Sleep Bruxism
Classification by specialty	Gastroenterology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the effect of gastric-acid inhibiting drug on treatment of sleep bruxism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	1. Frequency of sleep bruxism episodes 2. Masticatory muscle activity during sleep
Key secondary outcomes	1. Frequency of tooth grinding noises 2. Sleep-stage distribution 3. Frequency of micro-arousals

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1. Rabeprazole administration (10mg, 7-days, once a day, before dinner) 2. Washout period 3. Placebo administration (7-days, once a day, before dinner)
Interventions/Control_2	1. Placebo administration (7-days, once a day, before dinner) 2. Washout period 3. Rabeprazole administration (10mg, 7-days, once a day, before dinner)
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Patient with sleep bruxism
Key exclusion criteria	1. Individual with secondary sleep bruxism 2. Individual with sleep disorder except sleep bruxism 3. Individual with severe gastro-intestinal disease 4. Individual with any medication within three months
Target sample size	20

Research contact person
Name of lead principal investigator	Shouichi Miyawaki
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Orthodontics
Address	8-35-1, Sakuragaoka, Kagoshima, Japan
TEL	099-275-6252
Email	miyawaki@dent.kagoshima-u.ac.jp

Public contact
Name of contact person	Shouichi Miyawaki
Organization	Kagoshima University, Graduate School of Medical and Dental Sciences
Division name	Department of Orthodontics
Address	8-35-1, Sakuragaoka, Kagoshima, Japan
TEL	099-275-6252
Homepage URL
Email	miyawaki@dent.kagoshima-u.ac.jp

Sponsor
Institute	Department of Orthodontics, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Osaka City University

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	鹿児島大学医学部・歯学部附属病院(鹿児島県）

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 18 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 08 Month 01 Day
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2010 Year 11 Month 17 Day
Last modified on	2016 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005465