UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009563 |
|---|---|
| Receipt number | R000011219 |
| Scientific Title | Randomized study comparing simultaneous injection with sequential injection of Fulvestrant |
| Date of disclosure of the study information | 2012/12/17 |
| Last modified on | 2015/07/13 10:39:27 |
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Basic information
Public title
Randomized study comparing simultaneous injection with sequential injection of Fulvestrant
Acronym
Randomized study of injection methods of Fulvestrant
Scientific Title
Randomized study comparing simultaneous injection with sequential injection of Fulvestrant
Scientific Title:Acronym
Randomized study of injection methods of Fulvestrant
Region
| Japan |
Condition
Condition
Postmenopausal breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether simultaneous injection of Fulvestrant improves patient satisfaction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1) Visual analog scales for simultaneous and sequential injections of Fulverant
2) Patient choice of injection method of Fulverant for 3rd time and after
Key secondary outcomes
1) Time for injections
2) Questionnaire to patients regarding each injection method
3) Questionnaire to nurses regarding each injection method
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1st time:Two shots of Fulvestrant are injected to each buttock sequentially
2nd time:Those are injected to each buttock simultaneously
3rd Time and after:Those are injected to each buttock according to patients' choice
Interventions/Control_2
1st time:Two shots of Fulvestrant are injected to each buttock simultanously
2nd time:Those are injected to each buttock sequentially
3rd Time and after:Those are injected to each buttock according to patients' choice
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Postmenopausal patients requiring Fulvastrant clinically
patients who fulfill at least one of the following as a condition of menopause;
a:50 years of age or older
b:less than 50 years old and in the range of post-menopausal estradiol and FSH
c:patients receiving ovarian submission
2)From 50- to 75-years old
3)ECOG performance status of 0-2
4)Written informed consent obtained
Key exclusion criteria
1)Patients who are impossible to be enrolled with psychological diseases or disorder
2)Inappropriate patients by investigator' decision
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Narui |
Organization
Yokohama City University Medical Center
Division name
Breast and thyroid surgery
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
nr1@gc5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutaka Narui |
Organization
Yokohama City University Medical Center
Division name
Breast and thyroid surgery
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
nr1@gc5.so-net.ne.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 17 | 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
| 2012 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 17 | Day |
Last modified on
| 2015 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011219
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
