EUCTR2006-003327-36-GB
Active, not recruiting
Phase 1
Evaluation of the efficacy of colchicine with and without betamethasone mouthwash in the management of recurrent aphthous stomatitis - ART1
Guy's & St Thomas' NHS Foundation Trust0 sites136 target enrollmentJanuary 5, 2007
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Recurrent aphthous stomatitis (RAS)
- Sponsor
- Guy's & St Thomas' NHS Foundation Trust
- Enrollment
- 136
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with RAS will be recruited from the oral medicine clinic.
- •1\.Patients aged 18\-65 years of age
- •2\.Patients are willing and able to give informed consent to the study.
- •3\.Patients will be asked if they are involved in any other research. Care will be taken to ensure that participation in multiple studies will not compromise patient safety or undermine the scientific basis of the study. The overall burden to the participants will be considered.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Patients under 18 years of age or over 65 years of age
- •2\.Patients who do not adequately understand verbal explanations or written information given in English, or who have special communication needs and unable to give informed consent.
- •3\.Patients who are pregnant or breast feeding.
- •4\.Patients are unwilling or unable to comply with the study protocol
- •5\.Patients with severe or relevant allergy history
- •6\.Patients on systemic steroids
- •7\.Patients who have been taking colchicine or betamethasone mouthwash in the previous three months.
- •8\.Patients with a history of hypersensitivity to colchicine.
- •9\.Patients with blood dyscrasias
- •10\.Patients with a current or past history of any cardiac, renal, hepatic or gastrointestinal disease.
Outcomes
Primary Outcomes
Not specified
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