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
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
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
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
