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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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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2006-003327-36-GB |
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Date of registration:
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05/01/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of the efficacy of colchicine with and without betamethasone mouthwash in the management of recurrent aphthous stomatitis - ART1
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Scientific title:
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Evaluation of the efficacy of colchicine with and without betamethasone mouthwash in the management of recurrent aphthous stomatitis - ART1 |
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Date of first enrolment:
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08/01/2007 |
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Target sample size:
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192 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003327-36 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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.
11.Patients who are debilitated in any way.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Recurrent aphthous stomatitis (RAS)
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Intervention(s)
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Trade Name: Colchicine Tablets BP 0.5mg
Product Name: Colchichine Tablet BP 0.5mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Colchicine Tablets BP 0.5mg
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Trade Name: Betnesol Tablets
Pharmaceutical Form: Soluble tablet
INN or Proposed INN: BETAMETHASONE SODIUM PHOSPHATE
CAS Number: 151735
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
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Primary Outcome(s)
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Secondary Objective: To assess the effect of therapy on specific immunological markers to determine the mode of action of the drug
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Primary end point(s): The primary outcome measure is the Ulcer Severity Score as recorded on the final visit from the clinical history and examination and patient's diary.
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Main Objective: To assess the efficacy of topical steroid and Colchicine, individually and combined, in the treatment of RAS.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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