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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019976
Receipt No. R000023065
Scientific Title The analgesic effect of ropivacaine eye drops on ophthalmic postherpetic neuralgia
Date of disclosure of the study information 2015/11/28
Last modified on 2015/11/28

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Basic information
Public title The analgesic effect of ropivacaine eye drops on ophthalmic postherpetic neuralgia
Acronym ropivacaine eye drops for ophthalmic postherpetic neuralgia
Scientific Title The analgesic effect of ropivacaine eye drops on ophthalmic postherpetic neuralgia
Scientific Title:Acronym ropivacaine eye drops for ophthalmic postherpetic neuralgia
Region
Japan

Condition
Condition ophthalmic postherpetic neuralgia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the analgec effect of ropivacaine eye drops on ophthalmic postherpetic neuralgia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Numerical Rating Scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ropivacaine eye drops
Interventions/Control_2 saline eye drops
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1. greater than or equal to 20 years, less than 90 years
2. greater than or equal to 4 of NRS
Key exclusion criteria 1. Patients with need for eye treatment
2. Patients with insufficient communication due to consciousness disorder, dementia, psychological diseases
3. Patients with difficult communication due to aphasia, hard of hearing, vision impairment
4. Patients with serious heart or lung diseases
5. Patients with past medical history of drug drug allergy
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Akifumi Kanai
Organization kitasato University Hospital
Division name Anesthesiology
Zip code
Address 1-15-1 Kitasato, Sagamihara, Minami-ku
TEL 042-778-8111
Email kanaiakifumi@aol.com

Public contact
1st name of contact person
1st name
Middle name
Last name Akifumi Kanai
Organization kitasato University Hospital
Division name Anesthesiology
Zip code
Address 1-15-1 Kitasato, Sagamihara, Minami-ku
TEL 042-778-8111
Homepage URL
Email kanaiakifumi@aol.com

Sponsor
Institute Aensthesiology in Kitasato Univrtsity Hospital
Institute
Department

Funding Source
Organization Kitasato Univrtsity Hospital
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 11 Month 28 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 Enrolling by invitation
Date of protocol fixation
2009 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 28 Day
Last modified on
2015 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023065

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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