臨床研究等提出・公開システム

Date of registration	Nov. 16, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221311

Scientific Title	Long-term study of HFT-290 in patients with chronic pain.
Public Title	Long-term phase III study in patients with chronic pain.

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	Hisamitsu Pharmaceutical Co., Inc.
	Address	sodanshitsu@hisamitsu.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Multicenter, open-label, uncontrolled
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients with chronic pain persisting for at least 12 weeks before obtaining informed consent
	Exclusion Criteria	- Patients with abnormalities at the site of application - Patients in whom the primary cause of chronic pain (the target of evaluation) is considered to be persistent somatoform pain disorder - Patients who are scheduled to undergo an operation with a potential influence on the evaluation of pain for at least 7 days before starting administration of the investigational drug
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Chronic pain
Intervention(s)		investigational material(s) Generic name etc : HFT-290 (fentanyl citrate patch) INN of investigational material : Therapeutic category code : 821 Synthetic narcotics Dosage and Administration for Investigational material : Transdermal, once daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy, safety
Secondary Outcome

Primary Sponsor	Hisamitsu Pharmaceutical Co., Inc.
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-101348
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Mar. 07, 2013	Detail	Changes
3	Mar. 07, 2013	Detail	Changes
2	Nov. 16, 2010	Detail	Changes
1	Nov. 16, 2010	Detail

List of change history