UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000997 |
|---|---|
| Receipt number | 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 17:26:29 |
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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
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
hiwabuch@tochi.hosp.go.jp
Sponsor or person
Institute
Department of Dentistry and Oral Surgery, Tochigi National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001176
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