臨床研究等提出・公開システム

Date of registration	Sept. 07, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222960

Scientific Title	Phase II clinical study of HP-3150 in patients with low back pain.
Public Title	Phase II clinical study of HP-3150 in patients with low back 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, placebo-controlled, randomized,double-blind
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	-Patients in whom low back pain was diagnosed clinically
	Exclusion Criteria	-Patients with abnormalities at the planned application site. -Patients with a serious hematologic disorder, hepatic dysfunction, renal dysfunction, hypertension, heart failure, or another complication that is clinically problematic. -Patients who have undergone a procedure that may affect assessment of pain, including surgery, nerve block, or percutaneous laser disc decompression, within six months before giving informed consent. -Patients with pain attributable to a complication whose low back pain cannot be assessed properly.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Low back pain
Intervention(s)		investigational material(s) Generic name etc : HP-3150 INN of investigational material : Therapeutic category code : 264 Analgesics, anti-itchings, astrigents and anti-inflammatory agents Dosage and Administration for Investigational material : Transdermal control material(s) Generic name etc : HP-3150 Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Transdermal
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
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-153012
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Nov. 30, 2016	Detail	Changes
3	Nov. 30, 2016	Detail	Changes
2	Sept. 07, 2015	Detail	Changes
1	Sept. 07, 2015	Detail

List of change history