UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017664 |
|---|---|
| Receipt number | 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 11:32:18 |
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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
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
nagaoka3taro@gmail.com
Sponsor or person
Institute
Non-profit Organization Japanese Organisation for Reserch and Treatment of Cancer (JORTC)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020450
