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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031741
Receipt No. R000036014
Scientific Title Feasibility study of opioid-induced nausea and vomiting
Date of disclosure of the study information 2018/03/15
Last modified on 2019/08/12

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Basic information
Public title Feasibility study of opioid-induced nausea and vomiting
Acronym Feasibility study of opioid-induced nausea and vomiting
Scientific Title Feasibility study of opioid-induced nausea and vomiting
Scientific Title:Acronym Feasibility study of opioid-induced nausea and vomiting
Region
Japan

Condition
Condition Opioid-induced nausea and vomiting (OINV)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore impacts of dexamethasone for improving general condition of cancer patients on OINV for planning a clinical trial of OINV.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete response rate at 72 hour after initiation of opioids
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dexamethasone
Interventions/Control_2
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) Histologically or clinically confirmed malignant disease
2) Age >= 20 years
3) Planned regular doses of morphine, oxycodone, hydromorphone, codeine or tramadol >= 15mg/day MEDD
4) No prior opioid use within 21 days
5) No prior systemic steroid >5 mg PSL equivalent within 7 days
6) No nausea or vomiting within 7 days
7) No regular use of antiemetics, peristaltic enhancer or antipsychotics
8) Laboratory tests within 14 days meet criteria
9) Orally ingestible
10) Clear consciousness
11) Ability to fill out patient diary
12) Written informed consent
Key exclusion criteria 1) Brain metastasis with edema or meningeal carcinomatosis
2) Peritoneal dissemination, intestinal obstruction or intestinal stenosis with intestinal dilation
3) Constipation >= Grade 3
4) History of diabetes requiring medication
5) Administration of antineoplastic agents with high or moderate emetic risk within 21 days
6) Administration of antineoplastic agents with low emetic risk within 7 days
7) Abdominal surgery within 21 days
8) Infection requiring systemic treatment
9) Active peptic ulcer
10) History of HBV infection
11) Delirium within 1 year
12) History of steroid psychosis
13) Allergy to dexamethasone
14) Other conditions inappropriate for participating in the study
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Etsuko Aruga / Nobuhiko Seki
Organization Teikyo University School of Medicine
Division name Dpt. Palliative Medicine / Oncology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL 03-3964-1211
Email earuga@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Takagi
Organization Teikyo University School of Medicine
Division name Dpt. Palliative Medicine
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL 03-3964-1211
Homepage URL
Email ytakagi@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Self-funding
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 帝京大学病院(東京都)、がん・感染症センター都立駒込病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 15 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 15
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
2017 Year 03 Month 05 Day
Date of IRB
2017 Year 03 Month 14 Day
Anticipated trial start date
2017 Year 03 Month 26 Day
Last follow-up date
2019 Year 05 Month 15 Day
Date of closure to data entry
2019 Year 05 Month 15 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 15 Day
Last modified on
2019 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036014

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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