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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010710
Receipt No. R000012517
Scientific Title Effective treatment of rebamipide on xerostomia in Sjogrens syndrome patients:a pilot study -a double-blind placebo-controlled trial-
Date of disclosure of the study information 2013/05/15
Last modified on 2016/12/03

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Basic information
Public title Effective treatment of rebamipide on xerostomia in Sjogrens syndrome patients:a pilot study -a double-blind placebo-controlled trial-
Acronym Effective treatment of rebamipide on xerostomia
Scientific Title Effective treatment of rebamipide on xerostomia in Sjogrens syndrome patients:a pilot study -a double-blind placebo-controlled trial-
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Iwabuchi
Organization Tochigi medical center
Division name Department of Dentistry and Oral Surgery
Zip code
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
1st name
Middle name
Last name Hiroshi Iwabuchi
Organization Tochigi medical center
Division name Department of Dentistry and Oral Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 02 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000012517

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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