NCT01584947

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2 chronic-pain

Timeline
Completed

Started Apr 2012

Typical duration for phase_2 chronic-pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

April 23, 2012

Last Update Submit

February 17, 2016

Conditions

Chronic Pain

Keywords

Oral painLocal anestheticBupivacaine hydrochloride

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • 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.

Study Arms (2)

Placebo lozenge

PLACEBO COMPARATOR

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.

Drug: Placebo

Bupivacaine lozenge

ACTIVE COMPARATOR

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.

Drug: Bupivacaine

Interventions

BupivacaineDRUG

Bupivacaine lozenge taken 3 times a day for two weeks

Bupivacaine lozenge
PlaceboDRUG

Placebo lozenge taken three times a day for two weeks

Placebo lozenge

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Odontology, University of Copenhagen

Copenhagen, DK-2200, Denmark

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Anne Marie L Pedersen, Ph.d.

    Department of Odontology, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist, PhD

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 25, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2014

Study Completion

August 1, 2014

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

DK(1)