UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014622 |
|---|---|
| Receipt number | R000017013 |
| Scientific Title | Study of the efficacy and safety of fentanyl plasters in constipation symptoms associated with cancer pain treatment |
| Date of disclosure of the study information | 2014/07/23 |
| Last modified on | 2022/01/27 09:19:43 |
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Basic information
Public title
Study of the efficacy and safety of fentanyl plasters in constipation symptoms associated with cancer pain treatment
Acronym
fentanyl plasters study
Scientific Title
Study of the efficacy and safety of fentanyl plasters in constipation symptoms associated with cancer pain treatment
Scientific Title:Acronym
fentanyl plasters study
Region
| Japan |
Condition
Condition
digestive cancer patients
breast cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effect on the constipation of fentanyl plasters
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scoring of pain and constipation
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
Oxycodone/Fentanile
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Gastrointestinal cancer, breast cancer patients with cancer pain
Key exclusion criteria
Patients with respiratory depression
Patients with asthma
Patients with heart failure
Patients with convulsions, ileus
The patients with hypersensitivity to the opium alkaloids
Patients with hemorrhagic colitis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Tanaka |
Organization
Gifu University
Division name
Surgical Oncology
Zip code
501-1194
Address
1-1 Yanagido Gifu City
TEL
0582306235
yoshihirotana11@hotmail.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Tanaka |
Organization
Gifu University
Division name
Surgical Oncology
Zip code
501-1194
Address
1-1 Yanagido Gifu City
TEL
09054578954
Homepage URL
yoshihirotana11@hotmail.com
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Gifu University
Address
1-1 Yanagido, Gifu City
Tel
09054578954
yoshihirotana11@hotmail.com
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 23 | 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
10
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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 23 | Day |
Last modified on
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017013
