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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017664
Receipt No. R000020450
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
Date of disclosure of the study information 2015/05/25
Last modified on 2017/11/17

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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

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 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
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
2015 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
Registered date File name

Research case data
Registered date File name


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