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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000422
Receipt No. 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

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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
Email

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
Email ctrdinfo@kowa.co.jp

Sponsor
Institute KOWA company, ltd.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000509

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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