臨床研究等提出・公開システム

Date of registration	May. 26, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222864

Scientific Title	The double blind randomized comparative study of MRQ-01 in the cancer patients with breakthrough pain.
Public Title

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	MARUISHI PHARMACEUTICAL CO.,LTD
	Address	TEL:81-6-6962-0318
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		84
Study Type		Interventional
Study Design	Study Design	Multicenter:double blind randomized placebo-controlled comparative study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	The cancer-related breakthrough pain which rescue needs
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Cancer-related breakthrough pain
Intervention(s)		investigational material(s) Generic name etc : MRQ-01 INN of investigational material : fentanyl Therapeutic category code : 821 Synthetic narcotics Dosage and Administration for Investigational material : Oral mucosa patch control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral mucosa patch
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	Maruishi Pharmaceutical 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-152916
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	April. 07, 2017	Detail	Changes
7	April. 07, 2017	Detail	Changes
6	July. 07, 2016	Detail	Changes
5	July. 07, 2016	Detail	Changes
4	June. 22, 2015	Detail	Changes
3	June. 22, 2015	Detail	Changes
2	May. 26, 2015	Detail	Changes
1	May. 26, 2015	Detail

List of change history