臨床研究等提出・公開システム

Date of registration	Sept. 06, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221563

Scientific Title	Confirmatory study of HFT-290 in patients with chronic pain
Public Title	Phase III clinical 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, randomized, double-blind study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients with persistent chronic pain for 12 weeks or longer before obtaining informed consent.
	Exclusion Criteria	- Patients with abnormalities at the application site. - Patient with serious cardiac, hepatic, or renal dysfunction, serious respiratory disorders, serious respiratory depression, and other serious complications. - Patients undergoing elective surgery that may have an effect on evaluation of pain.
	Minimum Age	20age old over
	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-111603
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Mar. 11, 2013	Detail	Changes
3	Mar. 07, 2013	Detail	Changes
2	Sept. 06, 2011	Detail	Changes
1	Sept. 06, 2011	Detail

List of change history