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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Oracain II Aps
Information provided by (Responsible Party):
Anne Marie Lynge Pedersen, University of Copenhagen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Bupivacaine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Placebo
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.
 Drug: Bupivacaine
Bupivacaine lozenge taken 3 times a day for two weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584947


Locations
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Denmark
Department of Odontology, University of Copenhagen
Copenhagen, Denmark, DK-2200
Sponsors and Collaborators
Hvidovre University Hospital
Oracain II Aps
Investigators
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Principal Investigator: Anne Marie L Pedersen, Ph.d. Department of Odontology, University of Copenhagen
More Information
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Responsible Party: Anne Marie Lynge Pedersen, Dentist, PhD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01584947    
Other Study ID Numbers: 2011-006196-19
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Keywords provided by Anne Marie Lynge Pedersen, University of Copenhagen:
Oral pain
Local anesthetic
Bupivacaine hydrochloride
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents