UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007830
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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/
Email toshikai@sbccsg.org

Sponsor
Institute Saitama Breast Cancer Clinical Study Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009229

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.