UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027899 |
|---|---|
| Receipt number | R000031937 |
| Scientific Title | Investigation for safety and efficacy of a new antiseptic Olanexidine Gluconate in children |
| Date of disclosure of the study information | 2017/06/25 |
| Last modified on | 2018/09/18 22:38:49 |
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Basic information
Public title
Investigation for safety and efficacy of a new antiseptic Olanexidine Gluconate in children
Acronym
Investigation for safety and efficacy of a new antiseptic Olanexidine Gluconate in children
Scientific Title
Investigation for safety and efficacy of a new antiseptic Olanexidine Gluconate in children
Scientific Title:Acronym
Investigation for safety and efficacy of a new antiseptic Olanexidine Gluconate in children
Region
| Japan |
Condition
Condition
Patients who undergo surgery of catheter insertion or inguinal hernia
Classification by specialty
| Surgery in general | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to measure the safety and the efficacy of a new antiseptic Olanexidine gluconate in children.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome was determined to assess the rate of any adverse effect such as labo data, vital sign, subjective and objective symptom, erythema or irritation of the skin.
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
An applicator of 1.5% Olamexidine gluconate is used at surgical site.
The skin site exposed to 1.5% Olamexidine gluconate are inspected daily by the bed side nursse or physician to assess any adverse effect such as labo data, vital sign, subjective and objective symptom, erythema or irritation of the skin.
Blood concentration of 1.5% Olamexidine gluconate was measured at 0, 2, 24 hours after surgery to draw AUC curve in patients with catheter insertion.
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
| 1 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Children who undergo surgery for catheter insertion or inguinal hernia from 1 to 16 years
of age.
(2)No abnormal appearance of the skin for surgical incision.
(3)Informed concent was obtained from guardians.
Key exclusion criteria
(1)History of drug sensitivity.
(2)History of shock or hypersensitivity against Chlorhexidine gluconate.
(3)Patients having cutaneous disease
(4)Any patients who was judged as inappropriate candidate to enroll this study
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Watanabe |
Organization
National Center for Child Health and Development
Division name
Division of Surgery
Zip code
Address
2-10-1 Okura,Setagaya-ku, Tokyo 157-8535
TEL
03-3416-0181
watanabe-ts@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoko Hagino |
Organization
National Center for Child Health and Development
Division name
Division of Medical Research
Zip code
Address
2-10-1 Okura,Setagaya-ku, Tokyo 157-8535
TEL
03-3416-0181
Homepage URL
hagino-k@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 26 | 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
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031937
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
