UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007863 |
|---|---|
| Receipt number | R000009263 |
| Scientific Title | A second phase study for the cancer pain: Drug Rotation from Oral Opioid to Daily type Transdermal Fentanyl tape. |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2019/05/05 11:40:54 |
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Basic information
Public title
A second phase study for the cancer pain: Drug Rotation from Oral Opioid to Daily type Transdermal Fentanyl tape.
Acronym
PROOF study
Scientific Title
A second phase study for the cancer pain: Drug Rotation from Oral Opioid to Daily type Transdermal Fentanyl tape.
Scientific Title:Acronym
PROOF study
Region
| Japan |
Condition
Condition
cancer pain
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation on efficacy, QOL and safety of earlier drug rotation from oral opioid to daily type transdermal fentanyl tape for cancer pain patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of pain reduction
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
from oral opioid to transdermal fentanyl tape
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
1. Patients with moderate-severe cancer-related pain
2. In-patients and out-patients
3. Patients without a problem clear in cognitive ability
4. Age: = or >20
5. Patients who has received the notice to cancer
6. Patients considered as appropriate for the treatment of opioid by investigators
7. Patients who are provided informed, written consent for participation
Key exclusion criteria
1. Patients with serious hepatic, renal, heart or respiratory dysfunctions
2. Patients with medical history of psychiatry disease
3. Pregnant or nursing patients and patients who may be pregnant
4. Patients with disturbed consciousness
5. Contraindication to opioid
6. Patients who has received narcotic antagonist analgesic
7. Patients who is evaluated as in appropriate for this study by investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Katayama |
Organization
ISESAKI MUNICIPAL HOSPITAL
Division name
Department of Surgery
Zip code
Address
12-1, Tsunatorihonmachi, Isesaki-shi, Gunma, Japan
TEL
0270-25-5022
kazukatayama827@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Katayama |
Organization
ISESAKI MUNICIPAL HOSPITAL
Division name
Department of Surgery
Zip code
Address
12-1, Tsunatorihonmachi, Isesaki-shi, Gunma, Japan
TEL
0270-25-5022
Homepage URL
kazukatayama827@gmail.com
Sponsor or person
Institute
ISESAKI MUNICIPAL HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
ISESAKI MUNICIPAL HOSPITAL
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 01 | 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
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 29 | Day |
Last modified on
| 2019 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009263
