臨床研究等提出・公開システム

Date of registration	Nov. 19, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222298

Scientific Title	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and safety of AM-4 ointment for Post-Operative pain in Patients after Hemorrhoidectomy
Public Title

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	AMATO PHARMACEUTICAL PRODUCTS, LTD.
	Address	06-6204-2713
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multicenter
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	-Patients undergoing hemorrhoidectomy of hemorrhoids by ligation and excision -Patients whose ASA (American Society of Anesthesiologists) is 1 or 2
	Exclusion Criteria	-Patients with other serious complications -Patients with other anorectal diseases -Patients with previous or present allergic diseases and drug allergy -Patients who are pregnant, breast-feeding, and suspected pregnancy
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Post-operative pain after hemorrhoidectomy
Intervention(s)		investigational material(s) Generic name etc : AM-4 ointment INN of investigational material : Oxetacaine Therapeutic category code : 121 Local anesthetics Dosage and Administration for Investigational material : Topical application
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy and Safety Assessment of efficacy variables : Pain score Assessment of safety parameters : Adverse events
Secondary Outcome

Primary Sponsor	AMATO PHARMACEUTICAL PRODUCTS, LTD.
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-132347
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Feb. 10, 2015	Detail	Changes
3	Feb. 10, 2015	Detail	Changes
2	Nov. 19, 2013	Detail	Changes
1	Nov. 19, 2013	Detail

List of change history