臨床研究等提出・公開システム

Date of registration	Aug. 26, 2020
Last modified on	April. 01, 2022
Trial ID	jRCT2080225352

Scientific Title	Randomized, Double-Blind Study of AK1830 in Patients with low back pain
Public Title	Randomized, Double-Blind Study of AK1830 in Patients with low back pain

Completion Date or Terminated date	Jan. 31, 2022
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	No
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	ASAHI KASEI THERAPEUTICS CORPORATION
	Address
	Phone Number
	E-mail Address	ct-info@om.asahi-kasei.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	ASAHI KASEI THERAPEUTICS CORPORATION
	Address
	Phone Number
	E-mail Address	ct-info@om.asahi-kasei.co.jp

Recruitment Status	completed

Date of First Enrolment		Sept. 14, 2020
Target Sample Size		400
Study Type		Interventional
Study Design	Study Design	double-blind controlled study
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Patient with low back pain
	Exclusion Criteria	Patient has renal, hepatic, cardiac, pancreatic, or metabolic diseases or hematologic abnormality. Patients with a history or complication of malignancy within 5 years *Patient who are pregnant or may be pregnant, who wants to be pregnant during the trial period, patients who are nursing. Patient who cannot agree on proper contraception in the patient or the patient's female partner is a pregnant woman
	Minimum Age	20age old over
	Maximum Age	85age old under
	Gender	Both
Health Condition or Problem Studied		Low back pain
Intervention(s)		investigational material(s) Generic name etc : AK1830 INN of investigational material : - Therapeutic category code : 129 Other agents affecting peripheral nervous system Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Intensity of Low Back Pain
Secondary Outcome		safety Adverse events

Primary Sponsor	ASAHI KASEI THERAPEUTICS CORPORATION
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Adachi Kyosai Hospital Institutional Review Board
Address of IRB	1-36-8, Yanagihara, Adachi-ku, Tokyo, Japan
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	July. 20, 2020

Secondary ID No.	JapicCTI-205448
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	April. 01, 2022	(this page)	Changes
3	Nov. 16, 2021	Detail	Changes
2	Oct. 02, 2020	Detail	Changes
1	Aug. 31, 2020	Detail

List of change history