臨床研究等提出・公開システム

Date of registration	Dec. 22, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222702

Scientific Title	An otorhinolaryngological tissue penetration study of T-4288 in patients scheduled for surgery
Public Title	An otorhinolaryngological tissue penetration study of T-4288

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	FUJIFILM Toyama Chemical Co., Ltd.
	Address	https://www.fujifilm.co.jp/form/fftc/en/general/input.php?id=FFTCClinicalEn
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Multi-center, Open-labeled study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	1. Age: 20 years of age and older 2. Gender : Both 3. Other
	Exclusion Criteria	1.Have a presence of severe renal dysfunction, serious cardiovascular disorder or significant hepatic disorder 2.Have a history of allergy to macrolide antibiotics 3.Others
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		chronic sinusitis, chronic otitis media, chronic tonsillitis or palatine tonsil hypertrophy
Intervention(s)		investigational material(s) Generic name etc : T-4288 INN of investigational material : solithromycin Therapeutic category code : 614 Antibiotic preparations acting mainly on gram-positive bacteria and mycoplasma Dosage and Administration for Investigational material : Oral Single Dose
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety and pharmacokinetic profile
Secondary Outcome

Primary Sponsor	Toyama Chemical Co., Ltd.(Current FUJIFILM Toyama Chemical Co., 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-142754
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Oct. 02, 2018	Detail	Changes
5	Oct. 02, 2018	Detail	Changes
4	Jan. 11, 2017	Detail	Changes
3	Jan. 11, 2017	Detail	Changes
2	Dec. 22, 2014	Detail	Changes
1	Dec. 22, 2014	Detail

List of change history