UMIN-CTR Clinical Trial

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

Cancer Pain

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Gastrointestinal surgery
Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Pain Relief Rate

Key secondary outcomes

Adverse Effect
Quality of life
Patient Satisfaction
Compliance

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tohoku University Graduate School of Medicine Division of Integrated Surgery and Oncology

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Miyagi HBPCOG

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

04

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

04

Month

25

Day

Last modified on

2016

Year

12

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006117