UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008640 |
|---|---|
| Receipt number | R000010153 |
| Scientific Title | Use-results surveillance of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in severe allergic keratoconjunctivitis. |
| Date of disclosure of the study information | 2012/08/11 |
| Last modified on | 2012/08/07 19:04:44 |
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Basic information
Public title
Use-results surveillance of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in severe allergic keratoconjunctivitis.
Acronym
Use-results surveillance of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in severe allergic keratoconjunctivitis.
Scientific Title
Use-results surveillance of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in severe allergic keratoconjunctivitis.
Scientific Title:Acronym
Use-results surveillance of TALYMUS ophthalmic suspension 0.1% (tacrolimus) in severe allergic keratoconjunctivitis.
Region
| Japan |
Condition
Condition
Severe allergic 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 severe allergic keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean change in the total score of objective clinical signs
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Severe allergic keratoconjunctivitis patients whom the prior treatment with anti-allergic agents had been ineffective
Key exclusion criteria
Subjects are ineligible to participate in this surveillance, 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
Target sample size
1000
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
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
t-suenobu@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
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
| 2012 | Year | 08 | Month | 11 | 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 | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
*TALYMUS Ophthalmic Suspension 0.1%
Twice daily for 24 weeks
*Ten objective clinical signs are
observated for 24 weeks
Management information
Registered date
| 2012 | Year | 08 | Month | 07 | Day |
Last modified on
| 2012 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010153
