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

• ClinicalTrials.gov Identifier: NCT01584947
• Recruitment Status: Terminated
• First Posted: April 25, 2012
• Last Update Posted: February 19, 2016
• Sponsor: Hvidovre University Hospital
• Collaborator: Oracain II Aps
• Information provided by (Responsible Party): Anne Marie Lynge Pedersen, University of Copenhagen

Tracking Information

• First Submitted Date: April 23, 2012
• First Posted Date: April 25, 2012
• Last Update Posted Date: February 19, 2016
• Study Start Date: April 2012
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain
• 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.
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Pain

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 8, 2014): 31
• Original Estimated Enrollment (submitted: April 24, 2012): 60
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01584947
• Other Study ID Numbers: 2011-006196-19
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Hvidovre University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Oracain II Aps

Investigators

• Principal Investigator: Anne Marie L Pedersen, Ph.d.; Department of Odontology, University of Copenhagen

• PRS Account: Hvidovre University Hospital
• Verification Date: February 2016