Back to resultsClinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain
Primary Purpose
Chronic Pain
Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Bupivacaine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Oral pain, Local anesthetic, Bupivacaine hydrochloride
Eligibility 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
Sites / Locations
- Department of Odontology, University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo lozenge
Bupivacaine lozenge
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01584947
First Posted
April 23, 2012
Last Updated
February 17, 2016
Sponsor
Hvidovre University Hospital
Collaborators
Oracain II Aps
1. Study Identification
Unique Protocol Identification Number
NCT01584947
Brief Title
Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Because of a very slow patient recruitment.
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Oracain II Aps
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Oral pain, Local anesthetic, Bupivacaine hydrochloride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo lozenge
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Bupivacaine lozenge
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Bupivacaine lozenge taken 3 times a day for two weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo lozenge taken three times a day for two weeks
Primary Outcome Measure Information:
Title
Assessment of oral pain on the Visual Analog Scale
Description
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
Time Frame
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 Outcome Measure Information:
Title
Measure the inflammation markers in blood, saliva and tissue
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Marie L Pedersen, Ph.d.
Organizational Affiliation
Department of Odontology, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Odontology, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
DK-2200
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain
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