Clinical Trials with lozenge as local anaesthesia as treatment for oral pain of patients with burning mouth syndrome and Sjögrens syndrom

Phase 1

• Conditions: Oral pain caused by the illnesses burning mouth syndrome, Sjögren's syndrome and lichen planus; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-006196-19-DK
• Lead Sponsor: Clinical Research Centre, Hvidovre University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-30
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified