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

Hvidovre University Hospital

Status and phase: Terminated; Phase 2

Conditions: Chronic Pain

Treatments: Drug: Placebo; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01584947

2011-006196-19

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Placebo lozenge

Placebo Comparator group

Description:

The patients will be randomized to start two weeks treatment with either a bupivacaine lozenge or a placebo lozenge (taken three times a day). The two weeks treatment is followed by a week without treatment. Afterwards they start another two weeks treatment with the opposite type of lozenge from the first treatment period.

Treatment:

Drug: Placebo

Bupivacaine lozenge

Active Comparator group

Description:

The patient will be randomized to start two weeks treatment with either a bupivacaine lozenge or a placebo lozenge (taken three times a day). The two weeks treatment is followed by a week without treatment. Afterwards the patient starts another two weeks treatment with the opposite type of lozenge from the first treatment period.

Treatment:

Drug: Bupivacaine