UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001262 |
|---|---|
| Receipt number | 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 09:41:21 |
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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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001525
