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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005507
Receipt No. R000006117
Scientific Title Evaluation on an introduction method of fentanyl patch by using short-acting opioid for cancer pain management in the outpatient setting.
Date of disclosure of the study information 2011/04/26
Last modified on 2016/12/18

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Basic information
Public title Evaluation on an introduction method of fentanyl patch by using short-acting opioid for cancer pain management in the outpatient setting.
Acronym Evaluation on an introduction method of fentanyl patch by using short-acting opioid for cancer pain management in the outpatient setting.(Miyagi-HBPCOG 008)
Scientific Title Evaluation on an introduction method of fentanyl patch by using short-acting opioid for cancer pain management in the outpatient setting.
Scientific Title:Acronym Evaluation on an introduction method of fentanyl patch by using short-acting opioid for cancer pain management in the outpatient setting.(Miyagi-HBPCOG 008)
Region
Japan

Condition
Condition Cancer Pain
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation on efficacy and safety of the introduction method by using short-acting opioid for cancer pain patients in the outpatient setting.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain Relief Rate
Key secondary outcomes Adverse Effect
Quality of life
Patient Satisfaction
Compliance

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 introduction method of fentanyl patch by using short-acting opioid for cancer pain management
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 Cancer pain patients with various
malignant tumors.
Patient with 20 years of age or more at
the date of consent agreement.
Patients considered as appropriate for
the treatment of opioid by investigators.
Key exclusion criteria Patients with hypersensitivity to opioid
Patients with medical history of opiod
addiction
Patients considered necessary for
titration inpatient setting
Patients with respiratory dysfunctions
such as chronic lung disease
Patients with asthma
Patients with serious heart dysfunction
Patients with serious hepatic or renal
dysfunction
Patients with intracranial hypertension
and disturbed consciousness
Patients with skin disease such as
eczema and atopy at the attached site
Patients with 40 degree or more fever Homeostatically
Pregnant patients and patients who may possibly be pregnant.
Patients treated with opioid antagonists
such as pentazocine and buprenorphine
within 2 days prior to fentanyl patch
attachment.
Patients under the age of 20
Patients considered as inappropriate for
study by investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Unno
Organization Tohoku University Graduate School of Medicine
Division name Division of Hepato-Biliary Pancreatic Surgery Department of Surgery
Zip code
Address 1-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi, 980-8574 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kei Nakagawa
Organization Tohoku University Graduate School of Medicine
Division name Division of Integrated Surgery and Oncology
Zip code
Address
TEL 022-717-7205
Homepage URL
Email kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine Division of Integrated Surgery and Oncology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Miyagi HBPCOG
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

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 26 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 No longer recruiting
Date of protocol fixation
2011 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2014 Year 03 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
2011 Year 04 Month 25 Day
Last modified on
2016 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006117

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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