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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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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201207000396219 |
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Date of registration:
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19/07/2012 |
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Primary sponsor: |
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Public title:
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Adjuvant topical 5fluorouracil (5FU) for ocular surface squamous neoplasia
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Scientific title:
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A double-masked randomised placebo-controlled trial of adjuvant topical 5-fluorouracil (5FU) treatment following surgical excision of ocular surface squamous neoplasia. |
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Date of first enrolment:
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2012-08-03 |
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Target sample size:
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504 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201207000396219 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Simple randomisation using a radomisation table created by STATA software,
Numbered eyedrop bottles,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Stephen
Gichuhi |
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Address:
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PO Box 347
00202
Nairobi
Kenya |
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Telephone:
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+2540-722873059 |
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Email:
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sgichuhi@uonbi.ac.ke |
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Affiliation:
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Senior Lecturer & Consultant Ophthalmologist |
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Name:
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Stephen
Gichuhi |
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Address:
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PO Box 347
00202
Nairobi
Kenya |
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Telephone:
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+2540-722873059 |
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Email:
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sgichuhi@uonbi.ac.ke |
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Affiliation:
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Senior Lecturer & Consultant Ophthalmologist |
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Key inclusion & exclusion criteria
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Inclusion criteria: (i) Histologically proven ocular surface squamous neoplasia (OSSN)
(ii) Healed excision site.
(iii) At least 18 years of age.
Exclusion criteria: (i) Prior treatment with topical or subconjunctival antimetabolite drugs such as 5FU, Mitomycin C (MMC) to the same eye or systemic cytotoxic drugs.
(ii) Patients who may need more radical surgery than a simple excision eg. features suggestive of metastasis.
(iii) Pregnant or breastfeeding mothers.
Age minimum:
18 Year
Age maximum:
85 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ocular surface squamous neoplasia (OSSN)
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Primary Outcome(s)
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Development of histopathologically confirmed recurrent OSSN anytime during the first year after the primary surgery.
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Secondary Outcome(s)
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Adverse effects of using topical 5-FU 1% four times daily for one month.
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Secondary ID(s)
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6097
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ECCT/12/04/01
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P459/11/2011
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Source(s) of Monetary Support
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British Council for Prevention of Blindness (BCPB)
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