UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004495 |
|---|---|
| Receipt number | 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 17:44:01 |
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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
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
yokoshi@md.tsukuba.ac.jp
Sponsor or person
Institute
Division of Hematology, University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005316
