臨床研究等提出・公開システム

Date of registration	Oct. 29, 2021
Last modified on	Feb. 05, 2022
Trial ID	jRCT2032210400

Scientific Title	Examination of the safety and the efficacy for patients using NP037 with chronic pain
Public Title	Examination of the safety and the efficacy for patients using NP037 with chronic pain

Contact for Scientific Queries	Name	Kondo Masako
	Affiliation	Nipro Corporation
	Address	3023, Nojicho, Kusatsu, Shiga, JAPAN
	Telephone	+81-77-564-0500
	E-mail	kondo-masako@nipro.co.jp
Contact for Public Queries	Name	Kondo Masako
	Affiliation	Nipro Corporation
	Address	3023, Nojicho, Kusatsu, Shiga, JAPAN
	Telephone	+81-77-564-0500
	E-mail	kondo-masako@nipro.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 01, 2021
Actual date of first enrollment		Nov. 08, 2021
Target sample size		50
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients aged >=20 years at the time of consent, etc.
	Exclusion Criteria	Patients whom an investigator or a sub-investigator judged to have difficulty in trial enforcement, etc.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic pain
Intervention(s)		Put on a probe of NP037 in the pain site and treatment.
Primary Outcome(s)		Changes in VAS from first use to the end of the first use

Primary Sponsor	Nipro Corporation

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Telephone	+81-3-5123-0028
E-Mail	soudan@hurecs.org
Approval Status	Approval
Date of approval	Oct. 29, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 05, 2022	(this page)	Changes
2	Dec. 01, 2021	Detail	Changes
1	Oct. 29, 2021	Detail

List of change history