UMIN-CTR Clinical Trial

Basic information
Public title	Indomethacin oral spray for the analgesic effect of pain reduction in patient with oral mucositis due to cancer therapy: Randomized, double-blind, placebo-controlled phase II trial
Acronym	Indomethacin oral spray for the analgesic effect of pain reduction in patient with oral mucositis due to cancer therapy: Randomized, double-blind, placebo-controlled phase II trial
Scientific Title	Indomethacin oral spray for the analgesic effect of pain reduction in patient with oral mucositis due to cancer therapy: Randomized, double-blind, placebo-controlled phase II trial
Scientific Title:Acronym	Indomethacin oral spray for the analgesic effect of pain reduction in patient with oral mucositis due to cancer therapy: Randomized, double-blind, placebo-controlled phase II trial
Region	Japan

Condition
Condition	Patients with oral mucisitis due to cancer therapy
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Oto-rhino-laryngology Radiology Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the analgesic effect of indomethacin oral spray for cancer patients with oral mucisitis due to cancer therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brief Pain Inventry(BPI)- item6 change between before(0min) and after IOS treatment(30min).
Key secondary outcomes	1)Area Under the Curve of BPI-item6 after IOS teatment(0min,15min,60min,120min,180min and 240min) 2)BPI (item3,4,5,6,8) cange between before(0min) and after IOS treatment(24hours) 3)Global impression 4)Minimal clinically important difference 5)Adverse effect

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	IOS(0.8mg)is orally adminstered by spray after lunch.4hours later, IOS is administered before each meal and when pain appears.Treatment ends after 24hours from the initiation.
Interventions/Control_2	Placebo(0.8mg)is orally adminstered by spray after lunch.4hours later, IOS is administered before each meal and when pain appears.Treatment ends after 24hours from the initiation.
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)Able to give written informed consent 2)Patients aged 20 or above at the time of obtaining informed consent 3)Histologically confirmed diagnosis of cancer 4)Hospitalized patients with oral mucositis due to chemotherapy and/or radiotherapy 5)Patients with oral mucositis CTCAE(Ver. 4) Grade <=3 and received oral care 6)Patients with oral mucositis pain(BPI item5) >=4 7)Patients with expected survival of 1month or longer 8)Patients who can take oral drugs
Key exclusion criteria	1)Patients who have experience of IOS 2)Patients who have other important disorder that needs to be prioritized the treatment 3)Allergy due to NSAIDS 4)Patients who are judged to be inappropriate by the physician
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroka Nagaoka
Organization	University of Tsukuba Hospital
Division name	General Medicine and Primary Care, Team for Palliative Care
Zip code
Address	2-1-1 Amakubo,Tsukuba,Ibaraki 305-8576,Japan
TEL	029-853-3900
Email	nagaoka3taro@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Hiroka Nagaoka
Organization	Universiyy of Tsukuba Hospital
Division name	General Medicine and Primary Care, Team for Palliative Care
Zip code
Address	2-1-1 Amakubo,Tsukuba,Ibaraki 305-8576,Japan
TEL	029-853-3900
Homepage URL
Email	nagaoka3taro@gmail.com

Sponsor
Institute	Non-profit Organization Japanese Organisation for Reserch and Treatment of Cancer (JORTC)
Institute
Department

Funding Source
Organization	Japanese Society for Palliative Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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IRB Contact (For public release)
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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	筑波大学附属病院（茨城県）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
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Results
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Results Delayed
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Baseline Characteristics
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Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date
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Date trial data considered complete
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Other
Other related information

Management information
Registered date	2015 Year 05 Month 25 Day
Last modified on	2017 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020450

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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