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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014433
Receipt No. 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

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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
Email 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
Email chiken@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016792

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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