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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000997
Receipt No. R000001176
Scientific Title The non-blind test crossover controlled trial how we used a physically unimpaired person volunteer about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrate
Date of disclosure of the study information 2008/01/28
Last modified on 2013/05/19

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Basic information
Public title The non-blind test crossover controlled trial how we used a physically unimpaired person volunteer about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrate
Acronym A controlled trial about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrate
Scientific Title The non-blind test crossover controlled trial how we used a physically unimpaired person volunteer about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrate
Scientific Title:Acronym A controlled trial about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrate
Region
Japan

Condition
Condition Xerostomia due to Sjogren`s 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 gargle remedy of cevimeline hydrochloride hydrate and review the following. Propriety of contrast medicine (a false placebo), optimal time to the quantity of salivary secretion measurement after a study drug (a test drug and control medicine) gargle, 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 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes It is amount of increase in the unstimulated whole saliva secretion after gargle 90 minutes, gargle 60 minutes later, gargle 30 minutes later and gargle 15 minutes later.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 It is a gargle with a test drug(Cevimeline hydrochloride hydrate 30mg+Hachiazule(TM)gargle 2g+distilled water 50cc)for two minutes. wash out, It is a gargle with false placebo1 (Cevimeline hydrochloride hydrate 9mg+Hachiazule(TM)gargle 2g+distilled water 50cc)for two minutes. wash out, It is a gargle with false placebo2 (Hachiazule(TM)gargle2g+distilled water 50cc)for two minutes.
Interventions/Control_2 It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with a test drug for two minutes.
Interventions/Control_3 It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with a test drug for two minutes. wash out, It is a gargle with false placebo1 for two minutes.
Interventions/Control_4 It is a gargle with a test drug for two minutes. wash out, It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with false placebo1 for two minutes.
Interventions/Control_5 It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with a test drug for two minutes. wash out,It is a gargle with false placebo2 for two minutes.
Interventions/Control_6 It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with a test drug for two minutes.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria A gum test value is 10ml/10min excess.
The person who does not have a feeling of xerostomia.
The person who gets mutual understanding.
Key exclusion criteria The person that a gargle is impossible.
A person we have a history of sick treatment of facial nerve or is treating the present.
A person we have a history of sick treatment of trigeminus or is treating the present.
A person we have a history of salivary gland conditions treatment within six months before this agent administration start or is treating the present.
A person of diabetes mellitus.
A person having an extensive oral mucosa disorder.
The person who took the medicine that it was thought that we had an influence on salivary secretion during taking again within examination one month.
It is a hypersensitivity symptom and a person having contraindication in cevimeline hydrochloride hydrate and Hachiazule(TM) gargle.
The pregnancy and a woman nursing or a woman with pregnant likelihood.
In addition, the person who admitted that we were inappropriate though a study director performed the final examination.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Iwabuchi
Organization Tochigi National Hospital
Division name Department of Dentistry and Oral Surgery
Zip code
Address 1-10-37 Nakatomatsuri Utsunomiya-city Tochigi
TEL 028-622-5241
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Iwabuchi
Organization Tochigi National Hospital
Division name Department of Dentistry and Oral Surgery
Zip code
Address 1-10-37 Nakatomatsuri Utsunomiya-city Tochigi
TEL 028-622-5241
Homepage URL
Email hiwabuch@tochi.hosp.go.jp

Sponsor
Institute Department of Dentistry and Oral Surgery, Tochigi National Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Institute of Public Health
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
2008 Year 01 Month 28 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 Terminated
Date of protocol fixation
2007 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 01 Month 25 Day
Last modified on
2013 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001176

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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