UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010156 |
|---|---|
| Receipt number | R000011330 |
| Scientific Title | Therapy for salivary fistula and sialocele after parotid surgery using minocycline hydrochloric acid solution |
| Date of disclosure of the study information | 2013/03/03 |
| Last modified on | 2021/09/08 10:43:48 |
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Basic information
Public title
Therapy for salivary fistula and sialocele after parotid surgery using minocycline hydrochloric acid solution
Acronym
Therapy for salivary fistula and sialocele using minocycline
Scientific Title
Therapy for salivary fistula and sialocele after parotid surgery using minocycline hydrochloric acid solution
Scientific Title:Acronym
Therapy for salivary fistula and sialocele using minocycline
Region
| Japan |
Condition
Condition
salivary fistula and sialocele after parotid surgery
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To treat the salivary fistula and sialocele after parotid surgery using minocycline hydrochloric acid solution quickly and easily
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine the effect of the treatment on salivary fistula and sialocele and to assess complications of the treatment
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
Minocycline hydrochloric acid solution is injected into the salivary fistula and sialocele
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients without severe complications.
The patients who are fully explained about this therapy using the consent document and other documents by the study physician or study investigator and voluntarily agreed to this therapy in writing.
Key exclusion criteria
Those who are considered as inappropriate to register by attendant physician(s) because of the past history and/or complication(s).
Those who are know complications such as hypersensitivity to antibiotics including minocycline.
Pregnant or breast feeding females.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Iwai |
Organization
Kansai Medical University, Takii Hospital
Division name
Department of Otolaryngology
Zip code
570-8507
Address
10-15 Fumizonocho, Moriguchi city, Osaka, Japan
TEL
06-6992-1001
iwai@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Iwai |
Organization
Kansai Medical University, Takii Hospital
Division name
Department of Otolaryngology
Zip code
570-8507
Address
+81-6-6992-1001
TEL
06-6992-1001
Homepage URL
iwai@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University, Takii Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University, Takii Hospital
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
Takii Hospital, Kansai Medical University
Address
2-5-1 Shimmachi, Hirakata, Osaka
Tel
06-6992-1001
iwai@hirakata.kmu.ac.jp
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 | 03 | Month | 03 | 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
5
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 | 03 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 03 | Day |
Last modified on
| 2021 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011330
