UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009292 |
|---|---|
| Receipt number | 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 14:26:49 |
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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
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
kkaneko@ba2.so-net.ne.jp
Sponsor or person
Institute
Department of Otolaryngology, Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010522
