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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01238185
Date of registration: 09/11/2010
Prospective Registration: Yes
Primary sponsor: Institute of Head and Neck Studies and Education, United Kingdom
Public title: Aspirin Mouthwash in Treating Patients With Oral Leukoplakia
Scientific title: Oral Topical Cyclooxygenase Inhibitor (Aspirin) Mouthwash for Treatment of Oral Dysplasia
Date of first enrolment: February 2010
Target sample size: 40
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01238185
Study type:  Interventional
Study design:  Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United Kingdom
Contacts
Name:   Hisham Mehanna, MD
Address: 
Telephone:
Email:
Affiliation:  Institute of Head and Neck Studies and Education, United Kingdom
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Precancerous Condition
Intervention(s)
Drug: acetylsalicylic acid
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: biopsy
Primary Outcome(s)
COX-1 and COX-2 mRNA as assessed by qRT-PCR [Time Frame: No]
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]
PGE2 levels as assessed by enzyme immunosorbent assay [Time Frame: No]
Secondary Outcome(s)
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]
Global gene response of dysplastic tissue as assessed by Affymetrix gene expression microarrays [Time Frame: No]
Protein expression as assessed by ELISA and immunohistochemistry for VEGFA [Time Frame: No]
Tolerability and possible oral and other adverse effects using a questionnaire [Time Frame: Yes]
VEGF mRNA expression as assessed by qRT-PCR [Time Frame: No]
Secondary ID(s)
CDR0000688122
EU-21083
INHANSE-ASPOD
ISRCTN31503555
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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