UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004231 |
|---|---|
| Receipt number | R000005086 |
| Scientific Title | A randomized, open-label, crossover, prospective study to investigate utility of a new 24-hour application of transdermal fentanyl patch compared to 72-hour application of transdermal fentanyl patch. |
| Date of disclosure of the study information | 2010/09/21 |
| Last modified on | 2011/03/22 18:34:24 |
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Basic information
Public title
A randomized, open-label, crossover, prospective study to investigate utility of a new 24-hour application of transdermal fentanyl patch compared to 72-hour application of transdermal fentanyl patch.
Acronym
A randomized, open-label, crossover, prospective study to investigate utility of a new 24-hour application of transdermal fentanyl patch compared to 72-hour application of transdermal fentanyl patch.
Scientific Title
A randomized, open-label, crossover, prospective study to investigate utility of a new 24-hour application of transdermal fentanyl patch compared to 72-hour application of transdermal fentanyl patch.
Scientific Title:Acronym
A randomized, open-label, crossover, prospective study to investigate utility of a new 24-hour application of transdermal fentanyl patch compared to 72-hour application of transdermal fentanyl patch.
Region
| Japan |
Condition
Condition
Pain
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate efficacy, safety and degree of satisfaction such as availability about Fentos tape.
Clarify the clinical advantage of Fentos tape compared to Durotep MT patch.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Pain intensity daily
2.Adverse events daily
3.Result of questionnaire investigation about utility of each transdermal fentanyl patch
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.Fentos Tape
2.Durotep MT Patch
Duration of treatment periods:9 days
Interventions/Control_2
1.Durotep MT Patch
2.Fentos Tape
Duration of treatment periods:9 days
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
1.In-patient of Kitasato institute Hospital
2.Patient who have moderate or severe cancer-related pain
3.Patient who treated with strong opioids for pain management and score change of his/her face pain scale within 1
4.patient who is judged to change to transdermal fentanyl patch from other opioids
5.Patients who are provided informed, written consent for participation
Key exclusion criteria
1.Patient who have hypersensitivity to opioids
2.Patient who have history of opioid abuse
3.Patient who have skin disease (eczema or psoriasis) on the upper arms, flat surface of the upper torso or crural area
4.A body temperature higher than 40 degrees
5.Preganat or nursing patients and patients who may be pregnant
6.After application of fentanyl patch within two days, patient who is treated by opioid receptor antagonists such as pentazocine and buprenorphine or will be treated
7.Surgery in the preceding 7 days or scheduled
8.Patient under 20 years old
9.Patient who have a life expectancy of less than 1 month
10.Patient who judges that the primary physician is inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichiro Atsuda |
Organization
Kitasato Institute Hospital
Division name
Department of Pharmacy
Zip code
Address
5-9-1,SHIROKANE,MINATO-KU,TOKYO,108-8642,JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masatoshi saito |
Organization
Kitasato Institute Hospital
Division name
Department of Pharmacy
Zip code
Address
5-9-1,SHIROKANE,MINATO-KU,TOKYO,108-8642,JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Department of Pharmacy, Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
北里研究所病院 （東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 18 | Day |
Last modified on
| 2011 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005086
