臨床研究等提出・公開システム

Date of registration	Sept. 30, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222615

Scientific Title	DS-7113b extended-release (ER) tablet phase III study-A randomized double-blind comparison study with extended-release oxycodone in opioid-naive patients with cancer pain-
Public Title	DS-7113b extended-release tablet phase III study

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHISANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	A multicenter, active controlled, randomized, double-blind, parallel-group study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients receiving non-opioid analgesics for cancer pain, who have not been receiving opioid analgesics 2) Patients whose VAS is  35 mm and judged necessary to be treated with strong opioid analgesics 3) Patients with an ECOG Performance Status (PS) is 3, etc.
	Exclusion Criteria	Patients with symptom(s)/finding(s) falling under the contraindications or relative contraindications stated in the package insert for oral oxycodone hydrochloride and morphine hydrochloride, etc.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Moderate to severe cancer pain
Intervention(s)		investigational material(s) Generic name etc : DS-7113b ER tablet INN of investigational material : Hydromorphone hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration for Investigational material : Each patient will be administered 1 doses a day orally for 7 days. control material(s) Generic name etc : Oxycodone hydrochloride tablet INN of investigational material : Oxycodone Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration for Investigational material : Each patient will be administered 2 doses a day orally for 7 days.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Change of VAS between pre-treatment and end of treatment
Secondary Outcome		Response rate at end of treatment (analgesia improvement rate), efficacy and safety

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-142666
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Mar. 26, 2018	Detail	Changes
7	Mar. 26, 2018	Detail	Changes
6	Feb. 05, 2016	Detail	Changes
5	Feb. 05, 2016	Detail	Changes
4	Oct. 15, 2015	Detail	Changes
3	Oct. 15, 2015	Detail	Changes
2	Sept. 30, 2014	Detail	Changes
1	Sept. 30, 2014	Detail

List of change history