臨床研究等提出・公開システム

Date of registration	Nov. 08, 2024
Last modified on	Oct. 06, 2025
Trial ID	jRCT2031240474

Scientific Title	39-301: Special Drug Use-Results Survey of DEMSER (Improvement of catecholamine hypersecretion in pheochromocytoma)
Public Title	39-301: Special Drug Use-Results Survey of DEMSER

Contact for Scientific Queries	Name	Nakao Takafumi
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	1 -5 Doshomachi 2-chome, Chuo-ku, Osaka-shi, Osaka 541-8526, Japan
	Telephone	+81-6-6222-5501
	E-mail	pms_contact_ml@ono-pharma.com
Contact for Public Queries	Name	Nakao Takafumi
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	1 -5 Doshomachi 2-chome, Chuo-ku, Osaka-shi, Osaka 541-8526, Japan
	Telephone	+81-6-6222-5501
	E-mail	pms_contact_ml@ono-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 26, 2019
Actual date of first enrollment		June. 11, 2019
Target sample size		250
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who have recieved DEMSER for improvement of catecholamine hypersecretion in pheochromocytoma
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pheochromocytoma
Primary Outcome(s)		Safety items : Occurrence of adverse drug reactions and infections, factors considered to influence the safety Efficacy items : Overall improvement, metanephrines fractionation (24-hour urine collection, spot urine, free), catecholamines 3 fractionation (24-hour urine collection, spot urine, plasma), factors considered to influence the efficacy

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	Not being included in the items required by GPSP Ordinance, a central IRB is not in place. The study is planned to conduct an IRB at the study site as needed.
Address	none, Kanagawa
Date of approval	April. 17, 2019

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 06, 2025	(this page)	Changes
1	Nov. 08, 2024	Detail

List of change history