UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014433 |
|---|---|
| Receipt number | R000016792 |
| Scientific Title | Phase I/II study of Ibuprofen gargle for chemotherapy or chemo-radiation therapy induced mucositis oral |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2019/01/02 15:27:07 |
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Basic information
Public title
Phase I/II study of Ibuprofen gargle for chemotherapy or chemo-radiation therapy induced mucositis oral
Acronym
Phase I/II study of Ibuprofen gargle for mucositis oral
Scientific Title
Phase I/II study of Ibuprofen gargle for chemotherapy or chemo-radiation therapy induced mucositis oral
Scientific Title:Acronym
Phase I/II study of Ibuprofen gargle for mucositis oral
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Oto-rhino-laryngology |
| Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To characterize the safety of ibuprofen gargle.
To assess the effect of ibuprofen gargle treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety: Adverse events and serious adverse drug reactions, abnormal changes in hematology and chemistry lab values, specifically those associated with hepatic and renal function; and assessment of physical examinations, vital signs
Key secondary outcomes
1.pain score
2.Improvement level of feeding, taking medicine, drinking water, conversation, and sleep
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
ibuprofen gargle
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with age: <= 20 years
2.Patient will provide written informed consent and authorization to release personal health information.
3.Inpatients.
Key exclusion criteria
1.No known CNS metastasis.
2.Impairment of GI function or GI disease
3.Other concurrent severe and/or uncontrolled concomitant medical conditions
4.Impaired cardiac function or clinically significant heart disease, including any one of the following:
_Angina pectoris within 3 months
_Acute myocardial infarction within 3 months
_Other clinically significant heart disease
5.No exist the aspirin-induced asthma.
6.No known hypersensitivity to any component of study regimen.
7.No use of zidovudine
8.Drug dependence disease and alcoholism
9.Patients unwilling or unable to comply with the protocol
10.No use of aspirin
11.Under the pregnancy or the nursing
12.Women of child-bearing potential who are pregnant.
13.No participate in other clinical trials.
14.Without participating in a similar examination clinical trial
15.Patients judged inappropriate for this study by physicians.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Midori Hirai |
Organization
Kobe University Hospital
Division name
Department of Hospital Pharmacy
Zip code
Address
7-5-2 kusunoki-cho Chuo-ku Kobe Hyogo 650-0017 JAPAN
TEL
078-382-6669
ioroit@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Ioroi |
Organization
Kobe University Hospital
Division name
Department of Hospital Pharmacy
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6669
Homepage URL
chiken@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University 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
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
| 2014 | Year | 07 | Month | 01 | 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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 30 | Day |
Last modified on
| 2019 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016792
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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