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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01003613 |
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Date of registration:
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28/10/2009 |
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Primary sponsor: |
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Public title:
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Evaluation of Tranilast to Treat Pterygium Before Excision
TPS |
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Scientific title:
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Evaluation of Tranilast as Adjunctive Therapy Before Primary Pterygium Excision Compared With Conjunctival Autograft |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01003613 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Acacio AS Lima Filho, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of São Paulo |
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Name:
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Reinaldo Azoubel, Prof Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Prof Dr |
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Name:
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Gildasio C Almeida Jr, Prof Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sao Jose do Rio Preto University |
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Name:
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Vinicius Tadeu NS Nascimento, Student |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sao Jose do Rio Preto University |
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Name:
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Sidney JF Sousa, Prof Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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USP - Ribeirão Preto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Primary pterygium
Exclusion Criteria:
- Keratoconjunctivitis sicca
- Sjögren disease
- Vernal keratoconjunctivitis
- Acne rosacea
- Neurotrophic keratopathy
- Severe dysfunction of the meibomius glands
- Use of any immunosuppressive drug, through systemic and topical route
- Aged under 18 years of age and vulnerable groups
- Glaucoma and use of ocular hipotensor
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pterygium
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Intervention(s)
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Drug: Tranilast, and Tissucol
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Other: Beriplast P
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Primary Outcome(s)
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Recurrence rate at months six and twelve months Immunohistochemical and cell morphology analysis at the end of study, 12 months
[Time Frame: 6 and 12 months]
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Secondary Outcome(s)
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Patient discomfort at day one, six and twelve months Safety of Tranilast
[Time Frame: one day, 6 and 12 months]
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Secondary ID(s)
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3049/2009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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