UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000422 |
|---|---|
| Receipt number | R000000509 |
| Scientific Title | Randomized double blind comparative study of nipradilol, an alfa-1,beta-blocker with a nitric oxide donative action, and timolol, a non-selective beta-blocker, on the visual field in Japanese patients with normal-tension glaucoma. |
| Date of disclosure of the study information | 2006/05/25 |
| Last modified on | 2010/12/03 09:21:59 |
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Basic information
Public title
Randomized double blind comparative study of nipradilol, an alfa-1,beta-blocker with a nitric oxide donative action, and timolol, a non-selective beta-blocker, on the visual field in Japanese patients with normal-tension glaucoma.
Acronym
Japanese Normal Tension Glaucoma Treatment Study (JNTGTS)
Scientific Title
Randomized double blind comparative study of nipradilol, an alfa-1,beta-blocker with a nitric oxide donative action, and timolol, a non-selective beta-blocker, on the visual field in Japanese patients with normal-tension glaucoma.
Scientific Title:Acronym
Japanese Normal Tension Glaucoma Treatment Study (JNTGTS)
Region
| Japan |
Condition
Condition
Normal Tension Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of twice-daily instillation of 0.25% of nipradilol, an alfa-1, beta-blocker, vs. that of twice-daily instillation of 0.5% of timolol maleate, a non-selective beta-blocker, to inhibit progression of visual field defect in Japanese patients with normal-tension glaucoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
O'Brien score of each patient derived from the regression coefficient against time of mean sensitivity (MD value) by cluster measured using the Humphrey Field Analyzer C30-2
Key secondary outcomes
-Regression coefficient of MD value against time
-Regression coefficient of MD value against time by cluster
-Regression coefficient of corrected pattern standard deviation (CPSD) value against time
-Time to event of progression of visual field defect
-Intraocular pressure
-Time to occurrence of optic disc hemorrhage
-Time to occurrence of optic disc progression
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1 drop of 0.25% nipradilol ophthalmic solution is used in each eye two times a day for 3 years.
Interventions/Control_2
1 drop of 0.5% timolol ophthalmic solution is used in each eye two times a day for 3 years.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Patients with normal-tension glaucoma in one eye or both eyes who meet the following criteria:
1)Untreated intraocular pressure at visit is 18 mmHg or less
2)MD values measured using the Humphrey Field Analyzer C30-2 are -15.0 dB or higher in both eyes
3)At least one of the eyes meets the following criteria regarding the visual field:
(1)MD value is -12.0 dB or higher
(2)Meets Caprioli's criteria for "moderate"
-Male and female subjects between 20 and 60 years of age
Key exclusion criteria
Patients with
-Cataract which affects the visual field or corrected vision of <0.8
-Refraction of <-0.8D or >5.0D
-A history of invasive eye surgery
-Complication with serious retinal disease that affects the visual field
-Complications which require treatment using the following prohibited drugs:
i.e., drugs that influence intraocular pressure or blood flow, and drugs that have neuroprotective action
-Complication with diabetes mellitus
-Pulse rate of 50/min or less
-Routine systolic blood pressure of 110 mmHg or below
-Patients who are pregnant, nursing or are suspected of being pregnant
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Araie |
Organization
The University of Tokyo, Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
3-1, 7-chome, Hongo, Bunkyo-ku, Tokyo 133-8655, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
KOWA company, ltd.
Division name
Clinical Research Management Dept.Pharmaceutical Development Dept.
Zip code
Address
TEL
Homepage URL
ctrdinfo@kowa.co.jp
Sponsor or person
Institute
KOWA company, ltd.
Institute
Department
Personal name
Funding Source
Organization
KOWA company, ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2006 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/18773262?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
Number of participants that the trial has enrolled
Results
The effect of topical nipradilol and timolol on progression of visual field damage and IOP was found to be equivalent in Japanese NTG patients whose untreated IOP was 14mmHg.
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
| 2001 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 11 | Month | 01 | Day |
Other
Other related information
http://www.ncbi.nlm.nih.gov/pubmed/20700793
Management information
Registered date
| 2006 | Year | 05 | Month | 25 | Day |
Last modified on
| 2010 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000509
