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Clinical Trials/EUCTR2006-003327-36-GB
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.

Registry
who.int
Start Date
January 5, 2007
End Date
January 13, 2011
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Guy's & St Thomas' NHS Foundation Trust

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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