UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effective treatment of rebamipide on xerostomia in Sjogrens syndrome patients:a pilot study -a double-blind placebo-controlled trial-
Title of the study (Brief title)	Effective treatment of rebamipide on xerostomia
Region	Japan

Condition
Condition	Xerostomia in Sjogrens syndrome
Classification by specialty	Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We precede it if we perform randomized controlled trial to inspect preeminence of rebamipide, size of effect size for control medicine, size of a change between subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Amount of increase in the unstimulated whole saliva secretion after administration 8W
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rebamipide was administered orally at 100 mg each time three times a day after meals for 8 weeks.
Interventions/Control_2	Placebo was administered orally three times a day after meals for 8 weeks.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients was given Cevimeline hydrochloride hydrate or oral pilocarpine more than one year. However,the effect was insufficient. Patients who could come to the outpatient clinic for at least 12 weeks. Patients with a salivary flow rate of not more than 10 mL for 10 min in the chewing gum test and having subjective symptoms of xerostomia. The person who gets mutual understanding. Patients with white cell and platelet count judged to be normal.
Key exclusion criteria	Patients with a history of treatment or currently on treatment for facial or trigeminal neuropathy. Patients with a history of treatment or currently on treatment salivary gland disorders other than SS within 6 months before start of administration. Patients with diabetes. Patients with hypersensitivity to rebamipide. Patients now taking or who took within one month previously rebamipide. Patients taking other drug for the treatment of gastritis and gastric ulcer. Patients who have or might have upper digestive tract, hepatic or biliary disease. Patients with severe hepatic dysfunction or renal dysfunction. Women who are pregnant or who might be pregnant or lactating mothers.
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroshi Iwabuchi
Organization	Tochigi medical center
Division name	Department of Dentistry and Oral Surgery
Address	1-10-37 Nakatomatsuri Utsunomiya-city Tochigi
TEL	81-28-622-5241
Email	hiwabuch@tochi.hosp.go.jp

Public contact
Name of contact person	Hiroshi Iwabuchi
Organization	Tochigi medical center
Division name	Department of Dentistry and Oral Surgery
Address	1-10-37 Nakatomatsuri Utsunomiya-city Tochigi
TEL	81-28-622-5241
Homepage URL
Email	hiwabuch@tochi.hosp.go.jp

Sponsor
Institute	Tochigi medical center
Institute
Department

Funding Source
Organization	Clinical research division of tochigi medical center
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

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 18 Day
Anticipated trial start date	2013 Year 05 Month 15 Day
Last follow-up date	2014 Year 04 Month 30 Day
Date of closure to data entry	2014 Year 05 Month 31 Day
Date trial data considered complete	2014 Year 06 Month 30 Day
Date analysis concluded	2014 Year 12 Month 31 Day

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

Management information
Registered date	2013 Year 05 Month 14 Day
Last modified on	2016 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012517