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

Phase 2

Terminated

• Conditions: Chronic Pain
• Interventions: Drug: Placebo; Drug: Bupivacaine

• Registration Number: NCT01584947
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-25
• Primary Completion: 2014-01
• Study Completion: 2014-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo lozenge	Placebo	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.
Bupivacaine lozenge	Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Assessment of oral pain on the Visual Analog Scale	The patients assess their oral pain when they attend the four examinations and they fill in a diary for a total of four weeks.	Assessment of oral pain in patients with burning mouth syndrome, Sjögrens syndrome or lichen planus after treatment with a bupivacaine lozenge or a placebo lozenge.; The patient assess their oral pain on the visual analog scale when they attend the four examinations. The patients also fill in a diary for a total of four weeks where they are in treatment where they assess VAS for pain, dryness of the mouth and irregularity of taste

Secondary Outcome Measures

Name	Time	Method
Measure the inflammation markers in blood, saliva and tissue	Blood- and saliva samples are taken the four times the patient attend the examinations. They are taken over a periode of five weeks. Tissue samples are taken before the first treatment period starts and when the final treatment period is finished.	The inflammation markers in blood, saliva and tissue will be analyzed to investigate if there are changes in the level in patients with chronic oral pain.

Trial Locations

Locations (1)

Department of Odontology, University of Copenhagen; 🇩🇰 Copenhagen, Denmark