Clinical Trials with lozenge as local anaesthesia as treatment for oral pain of patients with burning mouth syndrome and Sjögrens syndrom

Clinical Trials with lozenge as local anaesthesia as treatment of oral pain in burning mouth syndrome and Sjögrens syndrome - SB Lozenge

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006196-19-DK

Enrollment

Registered

2012-01-30

Start date

2012-02-28

Completion date

Unknown

Last updated

2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral pain caused by the illnesses burning mouth syndrome, Sjögren's syndrome and lichen planus

Interventions

Product Name: Bupizenge Product Code: BUPI5 Pharmaceutical Form: Lozenge INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE CAS Number: 18010-40-7 Concentration unit: IU/mg international unit(s)/milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosed with burning mouth syndrome, Sjögren's syndrome or lichen planus - Women of child bearing potential using contraception - Age between 18 and 75 years - Ability to speak and understand danish - Ability to give oral and written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Pregnant and breastfeeding women - Known allergy to bupivacaine or other lokal anaesthetics of the amide type - Active infection requiring antibiotic treatment - Patients in immunsuppressive treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: The effect of the treatment with respectively bupivacaine- and placebo lozenges on subjective symptoms in burning mouth syndrome, Sjögren's syndrome and lichen planus such as pain in the oral mucosa, oral dryness and taste disturbances;Secondary Objective: - Analysis of possible inflammation markers in blood og saliva and examination of a possible effect of bupivacaine on the inflammation markers - Histological examination of buccal mucosa regarding inflammatory changes and characteristics of cytokines/kemokines and neuropeptides - Examination of side effects i connection with the treatment with bupivacaine lozenges;Primary end point(s): The effect of the treatment with respectively bupivacaine- and placebo lozenges on subjective symptoms in burning mouth syndrome, Sjögren's syndrome and lichen planus such as pain in the oral mucosa, oral dryness and taste disturbances;Timepoint(s) of evaluation of this end point: The patients evaluate their symptoms continuously	—

Measure

Time frame

Main Objective: The effect of the treatment with respectively bupivacaine- and placebo lozenges on subjective symptoms in burning mouth syndrome, Sjögren's syndrome and lichen planus such as pain in the oral mucosa, oral dryness and taste disturbances;Secondary Objective: - Analysis of possible inflammation markers in blood og saliva and examination of a possible effect of bupivacaine on the inflammation markers - Histological examination of buccal mucosa regarding inflammatory changes and characteristics of cytokines/kemokines and neuropeptides - Examination of side effects i connection with the treatment with bupivacaine lozenges;Primary end point(s): The effect of the treatment with respectively bupivacaine- and placebo lozenges on subjective symptoms in burning mouth syndrome, Sjögren's syndrome and lichen planus such as pain in the oral mucosa, oral dryness and taste disturbances;Timepoint(s) of evaluation of this end point: The patients evaluate their symptoms continuously

—

Secondary

Measure	Time frame
Secondary end point(s): - Analysis of possible inflammation markers in blood og saliva and examination of a possible effect of bupivacaine on the inflammation markers - Histological examination of buccal mucosa regarding inflammatory changes and characteristics of cytokines/kemokines and neuropeptides - Examination of side effects i connection with the treatment with bupivacaine lozenges;Timepoint(s) of evaluation of this end point: The tests will be taken before and after the treatment periods and the material will be analysed ongoing	—

Measure

Time frame

Secondary end point(s): - Analysis of possible inflammation markers in blood og saliva and examination of a possible effect of bupivacaine on the inflammation markers - Histological examination of buccal mucosa regarding inflammatory changes and characteristics of cytokines/kemokines and neuropeptides - Examination of side effects i connection with the treatment with bupivacaine lozenges;Timepoint(s) of evaluation of this end point: The tests will be taken before and after the treatment periods and the material will be analysed ongoing

—

Countries

Denmark

Contacts

Public ContactCharlotte Treldal

Clinical Research Centre

sugetablet@gmail.com004538626077

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026