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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT01238185 |
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Date of registration:
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09/11/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Aspirin Mouthwash in Treating Patients With Oral Leukoplakia
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Scientific title:
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Oral Topical Cyclooxygenase Inhibitor (Aspirin) Mouthwash for Treatment of Oral Dysplasia |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01238185 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Hisham Mehanna, 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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Institute of Head and Neck Studies and Education, United Kingdom |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Clinically diagnosed oral leukoplakia requiring a tissue biopsy for histological
diagnosis
- Attending the outpatient clinic
PATIENT CHARACTERISTICS:
- Not nursing
- No known or suspected sensitivity to aspirin or other nonsteroidal anti-inflammatory
drugs
- No diagnosis of asthma or angioedema
- No contraindications, including any of the following:
- Active peptic ulceration or a history of peptic ulceration
- Hemophilia or a history of bleeding disorders
- Gout or a history of gout
PRIOR CONCURRENT THERAPY:
- No concurrent regular use of aspirin for heart disease or other reasons
- No other concurrent nonsteroidal anti-inflammatory drugs
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Precancerous Condition
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Intervention(s)
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Other: laboratory biomarker analysis
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Drug: acetylsalicylic acid
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Genetic: gene expression analysis
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Other: questionnaire administration
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Procedure: biopsy
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Genetic: protein expression analysis
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Primary Outcome(s)
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COX-1 and COX-2 mRNA as assessed by qRT-PCR
[Time Frame: No]
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COX-1 and COX-2 protein expression as assessed by immunohistochemistry and quantified by immunoblotting to determine whether COX inhibition in oral dysplasia tissues is actually possible by use of the mouthwash formulation
[Time Frame: No]
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PGE2 levels as assessed by enzyme immunosorbent assay
[Time Frame: No]
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Secondary Outcome(s)
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Tolerability and possible oral and other adverse effects using a questionnaire
[Time Frame: Yes]
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Global gene response of dysplastic tissue as assessed by Affymetrix gene expression microarrays
[Time Frame: No]
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Protein expression as assessed by ELISA and immunohistochemistry for VEGFA
[Time Frame: No]
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Comparison of WHO histological grade and clinical size of dysplastic lesions before and after treatment and assessment of proliferating cell nuclear antigen
[Time Frame: No]
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VEGF mRNA expression as assessed by qRT-PCR
[Time Frame: No]
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Secondary ID(s)
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INHANSE-ASPOD
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EU-21083
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CDR0000688122
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ISRCTN31503555
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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