UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A quasi-randomized clinical trial of tapentadol versus oxycodone for initial control of moderate cancer-related pain
Title of the study (Brief title)	A comparison of tapentadol and oxycodone for cancer pain
Region	Japan

Condition
Condition	Malignant neoplasm
Classification by specialty	Not applicable Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This prospective study aims to investing the safety and efficacy of tapentadol and oxycodone for moderate 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 after 2-4weeks later (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	YES
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	Oral tapentadol (50-200 mg/day) was given until the initial sign of signify analgesia was detected by patients.
Interventions/Control_2	Oxycodone (10-40 mg) was given until the initial signs of signify analgesia was detected by patients.
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with moderate cancer-related pain (NRS 3-8 and STAS-J 2-3) Patients who agreed to participate in the study and signed informed consent form
Key exclusion criteria	Patients with previously receiving strong opioid analgesic administration. Patient with severe cancer-related pain (NRS 9-10 and/or STAS-J 4)
Target sample size	54

Research contact person
Name of lead principal investigator	Yasuro Kato
Organization	Kansai Electric Power Hospital
Division name	Department of Palliative Medicine
Address	2-1-7, Fukusima, Fukusima-ku, Osaka city, Osaka, 553-0003 Japan
TEL	06-6458-5821
Email	kato.yasuro@d5.kepco.co.jp

Public contact
Name of contact person	Yasuro Kato
Organization	Kansai Electric Power Hospital
Division name	Department of Palliative Medicine
Address	2-1-7, Fukusima, Fukusima-ku, Osaka city, Osaka, 553-0003 Japan
TEL	06-6458-5821
Homepage URL
Email	kato.yasuro@d5.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	None
Name of secondary funｄer(s)	None

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 09 Month 09 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 06 Month 16 Day
Anticipated trial start date	2015 Year 09 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 09 Day
Last modified on	2017 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021931