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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001262
Receipt No. R000001525
Scientific Title Post-marketing clinical study of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in vernal keratoconjunctivitis
Date of disclosure of the study information 2008/09/01
Last modified on 2009/07/22

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Basic information
Public title Post-marketing clinical study of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in vernal keratoconjunctivitis
Acronym Post-marketing clinical study of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in vernal keratoconjunctivitis
Scientific Title Post-marketing clinical study of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in vernal keratoconjunctivitis
Scientific Title:Acronym Post-marketing clinical study of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in vernal keratoconjunctivitis
Region
Japan

Condition
Condition Vernal keratoconjunctivitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and the safety of TALYMUS ophthalmic suspension 0.1% in patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Blood levels of tacrolimus
Mean change in the total score of objective clinical signs
Key secondary outcomes Change of 10 objective clinical signs
Change of 6 subjective symptoms

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TALYMUS Ophthalmic Suspension 0.1%(tacrolimus)
Twice daily for 12 weeks
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Vernal keratoconjunctivitis patients who have giant papillae despite the prior treatment with anti-allergic agents
Key exclusion criteria Subjects are ineligible to participate in this study, if they:
1. have a known hypersensitivity to tacrolimus hydrate or to any component of this drug
2. Are suffering from infectious eye disease
3. Are pregnant or may possibly be pregnant
4. Have used ocular tacrolimus hydrate(including clinical trials)
5. Need to take tacrolymus capsules, granules and/or injection(Prograf)
6. Need to wear contact lenses during treatment period
7. Have participated in any other clinical trials within 3 months prior to enrollment, or will be enrolled in any other clinical trials during the study period
8. Were judged an inadequate subject to enrollment by a medical doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Ohashi
Organization Ehime University, School of Medicine
Division name Department of Ophthalmology
Zip code
Address Shitsukawa, Touon-city, Ehime,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Senju Pharmaceutical Co., Ltd
Division name Post Marketing Surveillance Department
Zip code
Address
TEL
Homepage URL
Email t-suenobu@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
2008 Year 09 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
2008 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2009 Year 05 Month 01 Day
Date of closure to data entry
2009 Year 07 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2009 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 07 Month 22 Day
Last modified on
2009 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001525

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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