UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010710 |
|---|---|
| Receipt number | 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 21:38:17 |
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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
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
hiwabuch@tochi.hosp.go.jp
Sponsor or person
Institute
Tochigi medical center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012517
