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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010818
Receipt No. R000012664
Scientific Title Evaluation of combinational effect of Aprepitant and Dxamethasone on nausea and vomiting induced by high-emetic-risk chemotherapy in patients.
Date of disclosure of the study information 2013/05/28
Last modified on 2018/06/04

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Basic information
Public title Evaluation of combinational effect of Aprepitant and Dxamethasone on nausea and vomiting induced by high-emetic-risk chemotherapy in patients.
Acronym PROEMEND
Scientific Title Evaluation of combinational effect of Aprepitant and Dxamethasone on nausea and vomiting induced by high-emetic-risk chemotherapy in patients.
Scientific Title:Acronym PROEMEND
Region
Japan

Condition
Condition Patient who has high-emetic-risk chemotherapy as first-ilne
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate combinational effect of Aprepitant and Dxamethasone on nausea and vomiting induced by high-risk-chemotherapy in patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes *Severity of nausea
Key secondary outcomes *Severity of nausea
*Grading of appetite
*Used amount of per-request medication
*weariness
*hiccough

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A:
*1st course: Conventional therapy (Palonosetron 0.75mg i.v. on 1st day + Dexamathasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day) plus phosAprepitant (150mg i.v. on 1st day)
* 2nd course: Conventional therapy ((Palonosetron 0.75mg i.v. on 1st day + Dexamathasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day) plus phosAprepitant (150mg i.v. on 1st day)
Interventions/Control_2 Group B:
* 1st course: Conventional therapy (Palonosetron 0.75mg i.v. on 1st day + Dexamathasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day) plus phosAprepitant (150mg i.v. on 1st day)
* 2nd course: Conventional therapy ((Palonosetron 0.75mg i.v. on 1st day + Dexamathasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day) plus phosAprepitant (150mg i.v. on 1st day)
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)Patients who has high-emetic-risk chemotherapy as first line.
(2)Performance Status (ECOG)=0-2
Key exclusion criteria (1)Patients during pimozide administration
(2)Patients who has severe liver failure or renal failure
(3)Patients who enforced high- or moderate-emetic-risk chemotherapy in the past
(4)Patients who has vomited or provoed nausea in the 24 hours prior to start of chemotherapy
(5)Patients who is considered inappropriate as a target patient by a physician-in-charge
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashiro Goto
Organization Osaka Medical College Hospital
Division name Chemotherapy Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL 072-683-1221
Email in2030@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Goto
Organization Osaka Medical College Hospital
Division name Chemotherapy Cancter
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL 072-683-1221
Homepage URL
Email in2030@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College Hospital
Institute
Department

Funding Source
Organization Osaka Medical College Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 大阪医科大学附属病院(大阪府)
Osaka Medical College Hospital(Osaka Prefecture)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 28 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 No longer recruiting
Date of protocol fixation
2012 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 17 Day
Last follow-up date
2015 Year 12 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 28 Day
Last modified on
2018 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012664

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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