UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018144 |
|---|---|
| Receipt number | R000021015 |
| Scientific Title | A study for the new regimen of pilocarpine hydrochloride in patients with xerostomia |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/07/01 13:16:23 |
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Basic information
Public title
A study for the new regimen of pilocarpine hydrochloride in patients with xerostomia
Acronym
A study of pilocarpine hydrochloride in patients with xerostomia
Scientific Title
A study for the new regimen of pilocarpine hydrochloride in patients with xerostomia
Scientific Title:Acronym
A study of pilocarpine hydrochloride in patients with xerostomia
Region
| Japan |
Condition
Condition
xerostomia
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the improvement of oral environment, continuity, and side effect using pilocarpine hydrochloride mouthwash.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)dry mouth questionnaire with the visual analog scale (VAS)
2)total amount of saliva production
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After pilocaripine hydrochloride (5mg, increscent) is orally administered three times daily for 8 weeks, the granules of pilocaripine hydrochloride (0.5%) as mouthwash is administered three times daily for 8 weeks.
Interventions/Control_2
After the granules of pilocaripine hydrochloride (0.5%) as mouthwash is administered three times daily for 8 weeks, pilocaripine hydrochloride (5mg, increscent) is orally administered three times daily 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with xerostomia
2)Patients with obtained the informed consent in writing
Key exclusion criteria
patients who have contraindication to pilocarpine hydrochloride.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Kawase-Koga |
Organization
Tokyo Medical University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
6-7-1, Nishishinjuku, Shinjukuku, Tokyo160-0023, Japan
TEL
81-3-3342-6111
kogay@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Kawase-Koga |
Organization
Tokyo Medical University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
6-7-1, Nishishinjuku, Shinjukuku, Tokyo160-0023, Japan
TEL
81-3-3342-6111
Homepage URL
kogay@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 01 | Day |
Last modified on
| 2015 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021015
