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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name