Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain
|ClinicalTrials.gov Identifier: NCT01584947|
Recruitment Status : Terminated (Because of a very slow patient recruitment.)
First Posted : April 25, 2012
Last Update Posted : February 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Bupivacaine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||April 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||August 2014|
Placebo Comparator: Placebo lozenge
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.
Placebo lozenge taken three times a day for two weeks
Active Comparator: Bupivacaine lozenge
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.
Bupivacaine lozenge taken 3 times a day for two weeks
- Assessment of oral pain on the Visual Analog Scale [ 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. ]
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
- Measure the inflammation markers in blood, saliva and tissue [ 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. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584947
|Department of Odontology, University of Copenhagen|
|Copenhagen, Denmark, DK-2200|
|Principal Investigator:||Anne Marie L Pedersen, Ph.d.||Department of Odontology, University of Copenhagen|