臨床研究等提出・公開システム

Date of registration	April. 23, 2019
Last modified on	May. 12, 2022
Trial ID	jRCT2080224658

Scientific Title	ENT103 Phase 3 Clinical Study in Patients with Suppurative Otitis Media with Persistent or Prolonged Otorrhea
Public Title	ENT103 Phase 3 Clinical Study in Patients with Suppurative Otitis Media with Persistent or Prolonged Otorrhea

Completion Date or Terminated date	Sept. 30, 2021
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	CEOLIA Pharma Co. Ltd
	Address	Yanagiya Taiyo Building 4-3-16, Nihonbashi-Muromachi, Chuo-ku, Tokyo 103-0022, Japan
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	CEOLIA Pharma Co. Ltd
	Address	Yanagiya Taiyo Building 4-3-16, Nihonbashi-Muromachi, Chuo-ku, Tokyo 103-0022, Japan
	Phone Number
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		May. 10, 2019
Target Sample Size		200
Study Type		Interventional
Study Design	Study Design	Multicenter, placebo-controlled, randomized, double-blind comparison study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients who are diagnosed with acute otitis media or perforated chronic otitis media caused by an infection. (2) Patients who have clinically persistent suppurative otorrhea. (3) Patients who obtained a written informed consent on the participation in this clinical study.
	Exclusion Criteria	(1) Patients who received antibiotic treatment for acute otitis media, exudative otitis media or perforated chronic otitis media within 3 months prior to enrollment. (2) Patients who are diagnosed as eosinophilic otitis media, cholesteatoma otitis media, exudative otitis media or anti-neutrophil cytoplasmic antibody (ANCA) with associated vasculitis not to be treated by anti-microbial medication. (3) Patients who have a trend on otitis media of fungal or tubercle bacillus infection (including infection to the tympanic membrane). (4) Patients with otitis media with signs of viral infection (including infection to the tympanic membrane). (5) Patients who have a mastoiditis. (6) Patients who are observed to increase threshold of progressive pure sound bone conduction. (7) Patients who are equipped with implantable otologic medical devices such as cochlear implants. (8) Patients who have experienced inner ear dizziness within 3 months prior to enrollment. (9) Patients who have infections that require systemic treatment with antibiotics.
	Minimum Age	15age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Otitis media
Intervention(s)		investigational material(s) Generic name etc : ENT103 INN of investigational material : - Therapeutic category code : 132 Agents for otic and nasal use Dosage and Administration for Investigational material : Six to ten drops are instilled into the affected ear twice daily in the morning and evening. After instilled, the solution is kept in the ear for 10 minutes. control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Six to ten drops are instilled into the affected ear twice daily in the morning and evening. After instilled, the solution is kept in the ear for 10 minutes.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Clinical efficacy on elimination of inflammation at middle ear and tympanic membrane
Secondary Outcome		efficacy Duration until stopping otorrhea efficacy Bacteriological effects (bacterial loss rate, MIC for causative bacteria) efficacy Properties on otorrhea

Primary Sponsor	CEOLIA Pharma Co. Ltd
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	IRB of Okayama University Hospital
Address of IRB	2-5-1 Shikata-cho, Kita-ku,Okayama-city, Okayama, 700-8558, JAPAN
Phone Number of IRB	+81-86-235-7534
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Feb. 19, 2019

Secondary ID No.	JapicCTI-194730
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
2	May. 12, 2022	(this page)	Changes
1	May. 07, 2019	Detail

List of change history