UMIN-CTR Clinical Trial

Basic information
Public title	A clinical evaluation of safety of combination therapy with Rapid Onset Opioid and Short Acting Opioid.
Acronym	A clinical evaluation of safety of combination therapy with ROO and SAO.
Scientific Title	A clinical evaluation of safety of combination therapy with Rapid Onset Opioid and Short Acting Opioid.
Scientific Title:Acronym	A clinical evaluation of safety of combination therapy with ROO and SAO.
Region	Japan

Condition
Condition	Cancer Pain
Classification by specialty	Not applicable Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This prospective study aims to investigate the safety and efficacy of combination therapy of ROO and SAO for cancer pain.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Analgesic effects (NRS, STAS-J) Adverse effect rate
Key secondary outcomes	Efficacy rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Breakthrough pain was managed with fentanyl buccal tablet and short-acting opioid.
Interventions/Control_2	Breakthrough pain was managed with sublingual fentanyl and short-acting opioid.
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	Patients with cancer-related persistent pain who was controlled. Patients who agreed to participate in the study and signed informed consent form.
Key exclusion criteria	1. the hypersensitiveness to opioids 2. serious respiratory depression or serious chronic obstructive pulmonary disease 3. disturbance of consciousness or the lack of judgment ability 4. gastrointestinal obstruction 5. not applicable determined by the attending physician responsible for the trial.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toru Kajiyama
Organization	Kansai Electric Power Hospital
Division name	Department of Palliative Medicine
Zip code
Address	2-1-7, Fukushima, Fukushima-ku, Osaka City, Osaka, 553-0003 Japan
TEL	06-6458-5821
Email	mtkaji@live.jp

Public contact
Name of contact person	1st name Middle name Last name Motonao Kurahashi
Organization	Kansai Electric Power Hospital
Division name	Department of Pharmacy
Zip code
Address	2-1-7, Fukushima, Fukushima-ku, Osaka City, Osaka, 553-0003 Japan
TEL	06-6458-5821
Homepage URL
Email	kurahashi.motonao@c3.kepco.co.jp

Sponsor
Institute	Kansai Electric Power Hospital
Institute
Department

Funding Source
Organization	Kansai Electric Power 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	関西電力病院（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 03 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	2015 Year 02 Month 14 Day
Date of IRB	2015 Year 03 Month 23 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 03 Day
Last modified on	2020 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022217