UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005660 |
|---|---|
| Receipt number | 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 09:52:26 |
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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
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
komo1207@rs.noda.tus.ac.jp
Sponsor or person
Institute
Laboratory of medical safety management, Tokyo University of Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006689
