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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010156
Receipt No. 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 2013/03/03

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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
Middle name
Last name Hiroshi Iwai
Organization Kansai Medical University, Takii Hospital
Division name Department of Otolaryngology
Zip code
Address 10-15 Fumizonocho, Moriguchi city, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kansai Medical University, Takii Hospital
Division name Department of Otolaryngology
Zip code
Address +81-6-6992-1001
TEL
Homepage URL
Email

Sponsor
Institute Takii Hospital, Kansai Medical University
Institute
Department

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
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
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
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
2013 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 04 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
2013 Year 03 Month 03 Day
Last modified on
2013 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011330

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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