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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009292
Receipt No. R000010522
Scientific Title Efficacy and safety of acetaminophen in the treatment of patients with head and neck cancer
Date of disclosure of the study information 2012/11/08
Last modified on 2019/08/22

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Basic information
Public title Efficacy and safety of acetaminophen in the treatment of patients with head and neck cancer
Acronym Acetaminophen in the treatment of patients with head and neck cancer
Scientific Title Efficacy and safety of acetaminophen in the treatment of patients with head and neck cancer
Scientific Title:Acronym Acetaminophen in the treatment of patients with head and neck cancer
Region
Japan

Condition
Condition Head and neck cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of acetaminophen and etodolac in pain management of Japanese patients with head and neck cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain scores while eating
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Acetaminophen
Interventions/Control_2 Etodolac
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 Japanese patients who
1.were diagnosed as having head and neck cancer.
2.are undergoing chemoratiotherapy.
3.are complaining of pain (NRS1-6) caused by mucositis.
4.have not taken analgesic agents yet.
5.are thought to be relieved by non-opioid analgesics.
6.can take analgesic agents orally.
7.can give written informed consent.
Key exclusion criteria 1.Patients with peptic ulcer
2.Patients with severe blood disorder
3.Patients with severe liver dysfunction
4.Patients with severe renal dysfunction
5.Patients with severe cardiac dysfunction
6.Patients with known hypersensitivity to acetaminophen or etodolac
7.Female patients who are pregnant, lactating or possibly pregnant
8.Patients who are judged inappropriate for the clinical trial by attending physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken-ichi Kaneko
Organization Nagasaki University Hospital
Division name Department of Otolaryngology
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-801-7711
Email kkaneko@ba2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken-ichi Kaneko
Organization Nagasaki University Hospital
Division name Department of Otolaryngology
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-801-7711
Homepage URL
Email kkaneko@ba2.so-net.ne.jp

Sponsor
Institute Department of Otolaryngology, Nagasaki University Hospital
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 08 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
2012 Year 09 Month 25 Day
Date of IRB
2012 Year 05 Month 01 Day
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2014 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 08 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010522

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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