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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005660
Receipt No. R000006689
Scientific Title Efficacy of the sodium hydrogen carbonate and sugar ointment for inflammation around enteral nutrition through percutaneous endoscopic gastrostomy
Date of disclosure of the study information 2011/06/01
Last modified on 2014/03/19

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Basic information
Public title Efficacy of the sodium hydrogen carbonate and sugar ointment for inflammation around enteral nutrition through percutaneous endoscopic gastrostomy
Acronym Efficacy of the sodium hydrogen carbonate and sugar ointment for inflammation around enteral nutrition through percutaneous endoscopic gastrostomy
Scientific Title Efficacy of the sodium hydrogen carbonate and sugar ointment for inflammation around enteral nutrition through percutaneous endoscopic gastrostomy
Scientific Title:Acronym Efficacy of the sodium hydrogen carbonate and sugar ointment for inflammation around enteral nutrition through percutaneous endoscopic gastrostomy
Region
Japan

Condition
Condition inflammation around enteral
nutrition through percutaneous endoscopic gastrostomy
Classification by specialty
Gastroenterology Geriatrics Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of the sodium hydrogen carbonate and sugar ointment for inflammation caused by the acid leak in patients placed
enteral nutrition through percutaneous endoscopic gastrostomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes At 0, 1, 2, 3 and 4weeks after treatment.
Inflammation area
Red color scale
Improvement in inflammation
Improvement in pain
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The sodium hydrogen carbonate and sugar ointment group:
Apply sodium hydrogen carbonate and sugar ointment 0.1g/1cm^2 to the inflammatory area for 4 weeks. It is applied at least 2g/day and more than two times/day.
Interventions/Control_2 Control group
Continue present treatment for 4 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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who can be checked once a week in hospitals, outpatients, at home and in institutions.
2. Inflammation caused by leak.
3. Leak fluid indicate acid (=<pH6) twice (intervals over one day)
4. Over 60 years old
5. Subjects who understood the requirements of the study and signed the informed consent forms.
Key exclusion criteria 1. Patient with dermatitis around enteral nutrition through percutaneous endoscopic gastrostomy
2. Patients judged inappropriate by the doctor.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayo Komoda
Organization Tokyo University of Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL 04-7121-4134
Email komo1207@rs.noda.tus.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayo Komoda
Organization Tokyo University of Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL 04-7121-4134
Homepage URL
Email komo1207@rs.noda.tus.ac.jp

Sponsor
Institute Laboratory of medical safety management, Tokyo University of Science
Institute
Department

Funding Source
Organization Faculty of Pharmaceutical Sciences, Tokyo University of Science
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
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 医療法人社団寿光会 栗源病院(千葉県) 
医療法人社団富家会 富家千葉病院(千葉県)
医療法人おもと会  大浜第二病院(沖縄県)
医療法人 知命堂病院(新潟県)
医療法人 富田浜病院(三重県)
医療法人 友康会 行徳中央病院(千葉県)
医療法人 友康会 行徳中央クリニック(千葉県)
国民健康保険 富士吉田市立病院(山梨県)
庄内医療生活協同組合 鶴岡協立病院(山形県)
独立行政法人国立病院機構 七尾病院(石川県)
日吉台病院(千葉県)
医療法人社団 誠馨会 セコメディック病院(千葉県)
千葉・柏リハビリテーション病院(千葉県)
勝田台病院(千葉県)
中通リハビリテーション病院(秋田県)
皆川病院(栃木県)

Other administrative information
Date of disclosure of the study information
2011 Year 06 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 05 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2014 Year 01 Month 31 Day
Date of closure to data entry
2014 Year 01 Month 31 Day
Date trial data considered complete
2014 Year 01 Month 31 Day
Date analysis concluded
2014 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 05 Month 27 Day
Last modified on
2014 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006689

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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