UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004231
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Department of Pharmacy, Kitasato Institute Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.