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

Chronic Pain Clinical Trial

Official title:

Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Oral Mucosal Pain in Burning Mouth Syndrome, Sjögrens Syndrome and Lichen Planus.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01584947
• Other study ID #: 2011-006196-19
• Status: Terminated
• Phase: Phase 2
• First received: April 23, 2012
• Last updated: February 17, 2016
• Start date: April 2012
• Est. completion date: August 2014

Study information

• Verified date: February 2016
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: August 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Bupivacaine
Bupivacaine lozenge taken 3 times a day for two weeks
• Placebo
Placebo lozenge taken three times a day for two weeks

Locations

Country	Name	City	State
Denmark	Department of Odontology, University of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Oracain II Aps

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of oral pain on the Visual Analog Scale	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	The patients assess their oral pain when they attend the four examinations and they fill in a diary for a total of four weeks.	No
Secondary	Measure the inflammation markers in blood, saliva and tissue	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.	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.	No