Trial record 12 of 12 for:    "Burning mouth syndrome"

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

This study is currently recruiting participants.
Verified February 2013 by Hvidovre University Hospital
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: February 21, 2013
Last verified: February 2013
  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 or Sjögrens syndrome.


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 and Sjögrens Syndrome.

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Reduction of oral pain in burning mouth syndrome or Sjögrens syndrome after treatment with a bupivacaine lozenge [ Time Frame: The patients fill out a diary for a total of four weeks where they are in treatment where they assess VAS for pain, dryness of the mouth and irrigularity of taste ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in inflammation markers in blood, saliva and tissue after treatment with bupivacaine lozenges [ Time Frame: Blood- and saliva samples will be taken regularly over a periode of five weeks. Tissue samples will be taken before the first treatment period starts and when the final treatment period is finished. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (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 or Sjögrens syndrome
  • 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
  • Non smoker

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

Contacts
Contact: Ove Andersen, Ph.d., MD +45 38623335 ove.andersen@hvh.regionh.dk
Contact: Charlotte Treldal, Cand.pharm +45 38626077 sugetablet@gmail.com

Locations
Denmark
Department of Odontology, University of Copenhagen Recruiting
Copenhagen, Denmark, DK-2200
Contact: Anne Marie L. Pedersen, Ph.d.    +45 35326729    amlp@sund.ku.dk   
Principal Investigator: Anne Marie L Pedersen, Ph.d.         
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: February 21, 2013
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Burning Mouth Syndrome
Mouth Diseases
Stomatognathic Diseases
Anesthetics, Local
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014