EUCTR2011-006196-19-DKActive, not recruitingPhase 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 enrollmentStarted: January 30, 2012Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •F.1.3.1 Number of subjects for this age range 20
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
Investigators
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