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

This study has been terminated.
(Because of a very slow patient recruitment.)
Sponsor:
Collaborator:
Oracain II Aps
Information provided by (Responsible Party):
Anne Marie Lynge Pedersen, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01584947
First received: April 23, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Chronic Pain
Drug: Bupivacaine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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 [ 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: April 2012
Estimated Study Completion Date: August 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584947

Locations
Denmark
Department of Odontology, University of Copenhagen
Copenhagen, Denmark, DK-2200
Sponsors and Collaborators
Hvidovre University Hospital
Oracain II Aps
Investigators
Principal Investigator: Anne Marie L Pedersen, Ph.d. Department of Odontology, University of Copenhagen
  More Information

No publications provided

Responsible Party: Anne Marie Lynge Pedersen, Dentist, PhD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01584947     History of Changes
Other Study ID Numbers: 2011-006196-19
Study First Received: April 23, 2012
Last Updated: July 8, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Hvidovre University Hospital:
Oral pain
Local anesthetic
Bupivacaine hydrochloride

Additional relevant MeSH terms:
Burning Mouth Syndrome
Chronic Pain
Sjogren's Syndrome
Mouth Diseases
Stomatognathic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anesthetics, Local
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014