UMIN-CTR Clinical Trial

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
Last 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
Email	kazukatayama827@gmail.com

Public contact
1st 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
Email	kazukatayama827@gmail.com

Sponsor
Institute	ISESAKI MUNICIPAL HOSPITAL
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009263