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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029001
Receipt No. R000032945
Scientific Title A phase I clinical pharmacology study of SJP-0135
Date of disclosure of the study information 2017/10/01
Last modified on 2018/03/07

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Basic information
Public title A phase I clinical pharmacology study of SJP-0135
Acronym A phase I clinical pharmacology study of SJP-0135
Scientific Title A phase I clinical pharmacology study of SJP-0135
Scientific Title:Acronym A phase I clinical pharmacology study of SJP-0135
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the pharmacokinetics and safety of SJP-0135 compared to 0.1% brimonidine tartrate or 0.5% timolol ophthalmic solution administered one drop twice daily for 7 days to healthy subjects
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics on Day 7
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 One drop of SJP-0135 is instilled into each eye twice-daily (in the morning and in the evening) for 7 days.
Interventions/Control_2 One drop of 0.1% brimonidine tartrate ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 7 days.
Interventions/Control_3 One drop of 0.5% timolol ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 7 days.
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
20 years-old <=
Age-upper limit
35 years-old >=
Gender Male and Female
Key inclusion criteria 1) Written informed consent obtained after adequate explanation on participating the study
2) Japanese male or female aged 20 to 35 years at consent
3) Able and willing to adhere the study instructions to the subjects defined in the protocol and the study schedule
4) IOP >= 10 mmHg and =< 20 mmHg in each eye, and asymmetry of IOP not greater than 5 mmHg
Key exclusion criteria 1) Presence of any disease irrespective of receiving medical treatment
2) History of a serious systemic disease
3) History of a serious psychiatric disorder
4) History of bronchial asthma
5) History of ocular surgery or history of ocular injury considered to be inappropriate to participate in the study
6) History of drug allergy
7) Use of any drugs within 14 days prior to the start of the study treatment
8) Males or females who made blood donation of 400 mL or more within 84 days or 112 days, respectively, prior to the start of the study treatment
9) Participated in any other clinical trial within past 90 days and received any other investigational drug or plans to participate in any other clinical trial during the study
10) Presence of abnormal ophthalmologic findings
11) Anticipated wearing of any contact lenses
12) Best corrected acuity <1.0
13) Body mass index < 18.5 or >= 25.0
14) Females who are pregnant, breastfeeding, or potentially pregnant. Or females who desire to be pregnant or males whose partners desire to be pregnant, or males or females who do not intend to use a reliable means of contraception from consent to the end of the study
15) Prior ocular instillation of SJP-0135
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Araie
Organization Kanto Central Hospital
Division name -
Zip code
Address 6-25-1, Kamiyoga, Setagaya-ku, Tokyo, 158-8531 Japan
TEL 03-3429-1171
Email araie-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Takuro Sekiya
Organization Senju Pharmaceutical Co.,Ltd.
Division name Clinical Development
Zip code
Address 2-5-8, Hirano-machi, Chuo-ku, Osaka, Japan
TEL 06-6201-9605
Homepage URL
Email t-sekiya@senju.co.jp

Sponsor
Institute Senju Pharmaceutical Co.,Ltd.
Institute
Department

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
2017 Year 10 Month 01 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
2017 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 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
2017 Year 09 Month 05 Day
Last modified on
2018 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032945

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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