EUCTR2011-006196-19-DK
Active, not recruiting
Phase 1
Clinical Trials with lozenge as local anaesthesia as treatment of oral pain in burning mouth syndrome and Sjögrens syndrome - SB Lozenge
Clinical Research Centre, Hvidovre University Hospital0 sites60 target enrollmentJanuary 30, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Clinical Research Centre, Hvidovre University Hospital
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Diagnosed with burning mouth syndrome, Sjögren's syndrome or lichen planus
- •\- Women of child bearing potential using contraception
- •\- Age between 18 and 75 years
- •\- Ability to speak and understand danish
- •\- Ability to give oral and written consent
- •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 40
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\- Pregnant and breastfeeding women
- •\- Known allergy to bupivacaine or other lokal anaesthetics of the amide type
- •\- Active infection requiring antibiotic treatment
- •\- Patients in immunsuppressive treatment
Outcomes
Primary Outcomes
Not specified
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