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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004495
Receipt No. R000005316
Scientific Title Investigation of the efficacy of an antiemetic, aprepitant and its drug interaction with prednisolone in CHOP or R-CHOP therapy
Date of disclosure of the study information 2010/11/03
Last modified on 2013/12/03

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Basic information
Public title Investigation of the efficacy of an antiemetic, aprepitant and its drug interaction with prednisolone in CHOP or R-CHOP therapy
Acronym Investigation of the efficacy of aprepitant and its drug interaction with prednisolone in (R-)CHOP therapy
Scientific Title Investigation of the efficacy of an antiemetic, aprepitant and its drug interaction with prednisolone in CHOP or R-CHOP therapy
Scientific Title:Acronym Investigation of the efficacy of aprepitant and its drug interaction with prednisolone in (R-)CHOP therapy
Region
Japan

Condition
Condition non-Hodgkin lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate drug interaction of aprepitant and prednisolone by measurement of blood prednisolone concentration in combination with or without aprepitant in the patients treated by CHOP or R-CHOP, which is highly emetic chemotherapy and contains prednisolone.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Pharmacokinetics of prednisolone (and its metabolites). They are measured from day 3 to day 4 in the first (without aprepitant) and the second (with aprepitant) courses of (R-) CHOP therapy in every patient.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Antiemesis therapy with granisetron is performed on day 1 in the 1st course of (R-) CHOP therapy. In the 2nd course, 125 mg of aprepitant per os in a single administration, and 60 mg per os in a single administration on day 2 and 3, are added to the antiemesis therapy with granisetron.
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 A patient with non-Hodgkin lymphoma who is to be treated with (R-)CHOP therapy for the first time. Performance status (ECOG) grade 0 - 2, with estimated life expectancy of 3 months or more, and with sufficient blood count, liver and renal function.
Key exclusion criteria The use of drugs which affect metabolism of aprepitant and prednisolone, the use of antiemetics or drugs with antiemetic effect which is not prescribed within 48 hours before (R-)CHOP initiation, irradiation to the abdomen or pelvis within 6 days before (R-)CHOP initiation, the onset of vomitting or dry vomiting within 24 hours before (R-)CHOP initiation, symptomatic brain metastasis, beeing pregnant or lactating, the possibility of pregnancy, using oral contraceptive, previous use of aprepitant, diabetes mellitus with drug treatment, HbA1c >= 6.5 %, fasting blood glucose >= 126 mg/dl, psychiatric disorder, a patients who is considered as ineligible by the attending doctor.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Chiba
Organization University of Tsukuba
Division name Division of Hematology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Okoshi
Organization University of Tsukuba
Division name Division of Hematology
Zip code
Address
TEL 029-853-3127
Homepage URL
Email yokoshi@md.tsukuba.ac.jp

Sponsor
Institute Division of Hematology, University of Tsukuba
Institute
Department

Funding Source
Organization Division of Hematology, University of Tsukuba
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 筑波大学附属病院(茨城県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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
2010 Year 11 Month 01 Day
Last modified on
2013 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005316

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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