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	jRCT2080222616

Scientific Title	DS-7113b extended-release (ER) tablet phase III study-A DS-7113b extended-release tablet long-term study in patients with cancer pain-
Public Title	DS-7113b 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, open-label, uncontrolled study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Cancer pain patients meeting any of following 1) Patients on opioid analgesics (oral morphine, oral oxycodone, transdermal fentanyl, or tramadol) less than 240 mg in morphine equivalent and judged effective to be treated with strong opioid analgesics 2) Patients who have not been on opioid analgesics, whose VAS is 35 mm and over and judged necessary to be treated with strong opioid analgesics 3) Patients who prefer to take DS-7113b ER tablets after completion of the study treatment of DS7113-B-J303 trial
	Exclusion Criteria	Patients with symptom(s)/finding(s) falling under the contraindications or relative contraindications stated in the package insert of 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 : Prescribe starting dosage with frequency written in study protocol. Dosing period is maximum of 84 days. Increase or decrease the dosage if necessary.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy rate (post-switch improvement and analgesia improvement ) at each visit and early termination visit
Secondary Outcome		Pain Intensity (PI), 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-142667
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Mar. 27, 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