UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005620
Receipt number R000006640
Scientific Title Prospective study of effecacy and safety of switch from oral medicine of tramadolto fentanyl sticking medicine (dyuroteppu MT patch on the 3rd) in lung cancer and malignant pleura mesothelioma with the pain
Date of disclosure of the study information 2011/05/19
Last modified on 2014/11/04 09:00:30

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Basic information

Public title

Prospective study of effecacy and safety of switch from oral medicine of tramadolto fentanyl sticking medicine (dyuroteppu MT patch on the 3rd) in lung cancer and malignant pleura mesothelioma with the pain

Acronym

Prospective study of switch from oral medicine of tramadolto fentanyl sticking medicine in thoracic malignancy with the pain

Scientific Title

Prospective study of effecacy and safety of switch from oral medicine of tramadolto fentanyl sticking medicine (dyuroteppu MT patch on the 3rd) in lung cancer and malignant pleura mesothelioma with the pain

Scientific Title:Acronym

Prospective study of switch from oral medicine of tramadolto fentanyl sticking medicine in thoracic malignancy with the pain

Region

Japan


Condition

Condition

lung cancer, malignant mesothelioma

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Effecacy and the safety when switching from the tramadol to fentanyl sticking medcine in the third where the conversion chart based on 500:1 compared with general conversion is used in foreign countries are examined.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

(1)Effecacy
(2)Safety
(3)Patient satisfaction

Key secondary outcomes



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

Effecacy and the safety when switching from the tramadol to fentanyl sticking medcine in the third where the conversion chart based on 500:1 compared with general conversion is used in foreign countries are examined.

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

18 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1:Patient who has cancer pain in lung cancer and malignant pleura mesothelioma from which tramadol hydrochloric acid salt capsule in the following less than 300mg/day is administered
2:It is NRS(Numeric Rating Scale) in 11 stages (0-10) and it is a patient of five or less.

Key exclusion criteria

Patient who has hypersensitivity for opioid
Patient who has previous history of opioid abuse
Patient who has breath function trouble of chronic lung disorders etc.
Defective asthmatic patient to control
Patient who has serious depressed ventricular function
Patient who has serious liver and renal dysfunction
Patient who has increased intracranial pressure and impaired consciousness
Patient who has skin disorder such as eczema and atopy in experimental drug sticking part
Patient where generation of heat of 40 degree or more is admitted
Patient who has pregnant woman, breast-feeding woman or possibility of pregnancy
Patient who has scheduled patient or administering that administers pentazocine and Pius id receptor rivalry medicine of buprenorphine etc. within two days before it sticks it (The patient who executes the bronchoscope treatment excludes it).
Patient whose age is less than 18 years old

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomonori Hirashima

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Division name

Thoracic Malignancy

Zip code


Address

3-7-1 Habikino Habikino city Osaka Japan

TEL

072-957-2121

Email

moto19781205@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motohiro Tamiya

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Division name

Thoracic Malignancy

Zip code


Address

3-7-1 Habikino Habikino city Osaka Japan

TEL

+81-729-57-2121

Homepage URL


Email

moto19781205@yahoo.co.jp


Sponsor or person

Institute

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Institute

Department

Personal name



Funding Source

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

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

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases


Other administrative information

Date of disclosure of the study information

2011 Year 05 Month 19 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

Completed

Date of protocol fixation

2011 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 20 Day

Last follow-up date

2013 Year 05 Month 01 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 05 Month 19 Day

Last modified on

2014 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006640


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name