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

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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

Tracking Information
First Submitted Date  ICMJE April 23, 2012
First Posted Date  ICMJE April 25, 2012
Last Update Posted Date February 19, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2012)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2012)
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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain
Official Title  ICMJE Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Oral Mucosal Pain in Burning Mouth Syndrome, Sjögrens Syndrome and Lichen Planus.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: Bupivacaine
    Bupivacaine lozenge taken 3 times a day for two weeks
  • Drug: Placebo
    Placebo lozenge taken three times a day for two weeks
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 8, 2014)
31
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2012)
60
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01584947
Other Study ID Numbers  ICMJE 2011-006196-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Anne Marie Lynge Pedersen, University of Copenhagen
Original Responsible Party Anne Marie Lynge Pedersen, University of Copenhagen, Ph.d.
Current Study Sponsor  ICMJE Hvidovre University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Oracain II Aps
Investigators  ICMJE
Principal Investigator: Anne Marie L Pedersen, Ph.d. Department of Odontology, University of Copenhagen
PRS Account Hvidovre University Hospital
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP