UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019877
Receipt number R000022965
Scientific Title Phase I study of SJP-0118 in healthy elderly (once a daily and twice a daily dosing study)
Date of disclosure of the study information 2015/12/21
Last modified on 2016/07/28 09:17:43

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Basic information

Public title

Phase I study of SJP-0118 in healthy elderly (once a daily and twice a daily dosing study)

Acronym

Clinical efficacy study of SJP-0118

Scientific Title

Phase I study of SJP-0118 in healthy elderly (once a daily and twice a daily dosing study)

Scientific Title:Acronym

Clinical efficacy study of SJP-0118

Region

Japan


Condition

Condition

Healthy Elderly

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to determine the safety and the effect on external ocular surface bacterial flora of SJP-0118 in healthy elderly.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety evaluation (Clinical examination, Vital sign, Ophthalmic examination, Adverse event) will be assessed from day 1 to 4 and eradiation rates at day 4

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

SJP-0118 is instilled by once a day for 4 days.

Interventions/Control_2

SJP-0118 is instilled by twice on the first three days and once a day on the day 4.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Signature of the subject on the Informed Consent Form.
2) Male or female subject who is at least 65year of age.

Key exclusion criteria

1) Abnormal findings with ocular biomicroscopy in either eye.
2) History of recurrent corneal erosion syndrome.
3) Any corneal abnormalities (except for physiological superficial punctate keratitis) in either eye.
4) Subject with best-corrected visual acuity equal to or less than 0.3 in either eye.
5) History of ocular injury within the past 90 days.
6) Willing to use contact lens or punctual plug during the study.
7) Ocular surgery within the past 90 days in either eye.
8) Subject need to use any drugs (including over the counter drugs) within past 1 week and during the study.
9) Any cancer, clinically significant hepatic, renal, cardiovascular or endocrine system disorders.
10) Known hypersensitivity or adverse effect to azithromycin, any macrolide antibiotic, or to any of the ingredients in the study medications.
11) Participation in any other clinical study within past 90 days. Willing to participate in other clinical study during the study.
12) History of use azithromycin eye drops.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitsugu Inoue

Organization

Tottori University

Division name

Division of Ophthalmology and Visual Science, Faculty of Medicine

Zip code


Address

86 Nishi-cho,Yonago-shi,Tottori-ken, Japan

TEL

0859-33-1111

Email

yoinoue@grape.med.tottori-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshikuni Nakamura

Organization

Senju Pharmaceutical co.,ltd.

Division name

Regulatory Affairs & Medical Writing, Clinical Development

Zip code


Address

2-5-8, Hirano-machi, Chuo-ku, Osaka, Japan

TEL

06-6201-9605

Homepage URL


Email

y-nakamura@senju.co.jp


Sponsor or person

Institute

Senju Pharmaceutical co.,ltd.

Institute

Department

Personal name



Funding Source

Organization

Senju Pharmaceutical co.,ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 11 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 20 Day

Last modified on

2016 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022965


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name