UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007830 |
|---|---|
| Receipt number | R000009229 |
| Scientific Title | Efficacy and safety of One-day transdermal fentanyl switching from immediately-release oxycodone in advanced breast cancer patients. |
| Date of disclosure of the study information | 2012/04/25 |
| Last modified on | 2017/11/30 18:08:36 |
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Basic information
Public title
Efficacy and safety of One-day transdermal fentanyl switching from immediately-release oxycodone in advanced breast cancer patients.
Acronym
Efficacy and safety of One-day transdermal fentanyl switching from immediately-release oxycodone in advanced breast cancer patients.
Scientific Title
Efficacy and safety of One-day transdermal fentanyl switching from immediately-release oxycodone in advanced breast cancer patients.
Scientific Title:Acronym
Efficacy and safety of One-day transdermal fentanyl switching from immediately-release oxycodone in advanced breast cancer patients.
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Hematology and clinical oncology |
| Surgery in general | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the of Efficacy and safety of One-day transdermal fentanyl switching from immediately-release oxycodone in advanced breast cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient satisfaction at day 14 and day 28
Key secondary outcomes
Physician satisfaction at day 28
Pain degree at day 14 and day 28
4-level evaluation of Nausea, Vommiting, constipation, daytime drowsiness at day 14 and day 28
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Advanced breast cancer patients with moderate to severe pain
Key exclusion criteria
Oxnorm Contraindications
1)Severe respiratory depression, severe COPD
2)During acute attack of bronchial asthma
3)Secondary cardiac failure of chronic pulmonary diseases
4)During convulsive state
5)Paralytic ileus
6)Hypersensitivity to a group of opium alkaloids
7)Hemorrhagic colitis
8)Bacterial diarrhea
OneDuro Patch Contraindication
1)hypersensitivity to any of the ingredients of the product
Careful Administration
2)Respiratory dysfunctions such as chronic lung diseases
3)Asthma
4)Severe bradyarrhythmia
5)Severe hepatic or renal dysfunction
6)Organic brain disorders such as intracranial hypertension, disturbed consciousness, coma or brain cancer
7)Skin diseases such as atopic dermatitis ieczema on adhesive site
8)40dgree or more fever
9)History of drug dependence
10)Pregnancy, nursing women
11)Within next 2 days before using Fentanyl patch, antagonists of opioid receptor such as Pentazocine or Buprenorphine etc. are administered or planned to administer
12)below the age of 20
13)Attending doctors judgement
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazushige Futsuhara |
Organization
Saitama Medical Center Jichi medical Univercity
Division name
Depertment of Surgery
Zip code
Address
1-847,Amanuma-cho,Omiya-kuSaitama-shiSaitama,Japan 330-0834
TEL
048-647-2111
kazushige666@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Kai |
Organization
Shintoshin Ladies' Mammoclinic
Division name
Surgery
Zip code
Address
3F Capital Building 4-261-1 Kishikicho, Oomiya-ku, Saitama-shi, Saitama, Japan 330-0843
TEL
048-600-1722
Homepage URL
http://www.sbccsg.org/
toshikai@sbccsg.org
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group
Institute
Department
Personal name
Funding Source
Organization
none
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
自治医大さいたま医療センター，埼玉県立がんセンター，さいたま赤十字病院，赤心堂病院，三井病院，春日部市立病院，埼玉社会保険病院，川口市立医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Patient satisfaction at day 14 and day 28
Physician satisfaction at day 28
Pain degree at day 14 and day 28
4-level evaluation of Nausea, Vommiting, constipation, daytime drowsiness at day 14 and day 28
Management information
Registered date
| 2012 | Year | 04 | Month | 24 | Day |
Last modified on
| 2017 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009229
| 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 |
