UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation on an introduction method of fentanyl patch by using short-acting opioid for cancer pain management in the outpatient setting.
Title of the study (Brief title)	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	Michiaki Unno
Organization	Tohoku University Graduate School of Medicine
Division name	Division of Hepato-Biliary Pancreatic Surgery Department of Surgery
Address	1-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi, 980-8574 Japan
TEL
Email

Public contact
Name of contact person	Kei Nakagawa
Organization	Tohoku University Graduate School of Medicine
Division name	Division of Integrated Surgery and Oncology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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