UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005276 |
|---|---|
| Receipt number | R000006195 |
| Scientific Title | Efficacy and safety of Oral pirocarpin for xerostomia patients. |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2015/03/18 10:08:33 |
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Basic information
Public title
Efficacy and safety of Oral pirocarpin for xerostomia patients.
Acronym
Study on xerostomia patients.
Scientific Title
Efficacy and safety of Oral pirocarpin for xerostomia patients.
Scientific Title:Acronym
Study on xerostomia patients.
Region
| Japan |
Condition
Condition
xerostomia
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of the study is to investigate efficacy and safety of oral pilocarpine for xerostomia patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantity of the stimulated saliva
Level of oral moisture measured by a moisture checker
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
5mg of oral pilocarpine
three times daily
24 weeks follow up
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
xerostomia patients
Key exclusion criteria
Contraindication to oral pilocarpine.
Pregnancy or women with suspected pregnancy.
The patients who could not be provided with informed consent.
Unsuitability for the trial based on clinical judgement.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumiko Ohbayashi |
Organization
Kagawa University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture
TEL
087-891-2227
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko Ohbayashi |
Organization
Kagawa University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture
TEL
087-891-2227
Homepage URL
Sponsor or person
Institute
Faculty of Medicine, Kagawa University
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
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
香川大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | 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
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
stimulated whole saliva
oral misture
Management information
Registered date
| 2011 | Year | 03 | Month | 18 | Day |
Last modified on
| 2015 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006195
