Overview

Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain

Status:
Terminated
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of the project is to do a fase two trial, where the effect of a local anesthetic lozenge will be tested in regard to oral pain, dryness of the mouth, irregularity of taste as well as investigate a potential antiinflammatory effect in patients with burning mouth syndrome, Sjögrens syndrome and lichen planus.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hvidovre University Hospital
Collaborator:
Oracain II Aps
Treatments:
Anesthetics
Anesthetics, Local
Bupivacaine
Criteria
Inclusion Criteria:

- Diagnosed with burning mouth syndrome, Sjögrens syndrome or lichen planus

- All fertile women need to use save contraception

- Age between 18 and 75 years

- Able to speak, read and understand the danish language

- Must be informed orally and release a written consent and a signed authorization
statement

Exclusion Criteria:

- Pregnant or breastfeeding women

- Known allergy to bupivacaine or other local anesthetics of the amide type

- Active infection which requires antibiotic treatment

- Patients in immune suppressive treatment