E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Oral pain caused by the illnesses burning mouth syndrome, Sjögren's syndrome and lichen planus |
Smerter i mundhulen forårsaget af lidelserne burning mouth syndrome, Sjögrens syndrom og lichen planus |
|
E.1.1.1 | Medical condition in easily understood language |
Oral pain caused by the illnesses burning mouth syndrome, Sjögren's syndrome and lichen planus |
Smerter i mundhulen forårsaget af lidelserne burning mouth syndrome, Sjögrens syndrom og lichen planus |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
Effekten af behandling med hhv. bupivacain- og placebosugetablet på subjektive symptomer ved burning mouth syndrome, Sjögrens syndrom og lichen planus som brændende smerter i mundslimhinden, mundtørhed og smagsforstyrrelser |
|
E.2.2 | Secondary objectives of the trial |
- 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 |
- Analyse af evt. inflammationsmarkører i blod og spyt, samt vurdering af en evt. effekt af bupivacain på inflammationsmarkørerne - Histologisk undersøgelse af bukkale mukosa med henblik på forekomst af inflammatoriske forandringer samt immunhistokemisk karakteristik af cytokiner/kemokiner og neuropeptider - Vurdering af bivirkninger i forbindelse med behandlingen med bupivacainsugetablet |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
- Diagnosticeret burning mouth syndrome, Sjögrens syndrom eller lichen planus - Alle fertile kvinder skal bruge sikker antikonception, i form af p-piller, spiral, depotinjektion af gestagen, subdermal implantation, hormonal vaginalring eller transdermal depotplaster - Alder mellem 18 og 75 år - Skal være i stand til at tale og forstå dansk -Skal kunne afgive informeret samtykke |
|
E.4 | Principal 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
|
- Gravide eller ammende kvinder - Kendt overfølsomhed overfor bupivacain eller andre lokalanalgetika af amidtypen - Aktiv infektion som kræver antibiotisk behandling - Patienter i behandling med immunsuppressiv behandling |
|
E.5 End points |
E.5.1 | 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 |
Effekten af behandling med hhv. bupivacain- og placebosugetablet på subjektive symptomer ved burning mouth syndrome, Sjögrens syndrom og lichen planus som brændende smerter i mundslimhinden, mundtørhed og smagsforstyrrelser |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The patients evaluate their symptoms continuously
|
Patienterne vurderer deres symptomer løbende
|
|
E.5.2 | 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 |
- Analyse af evt. inflammationsmarkører i blod og spyt, samt vurdering af en evt. effekt af bupivacain på inflammationsmarkørerne - Histologisk undersøgelse af bukkale mukosa med henblik på forekomst af inflammatoriske forandringer samt immunhistokemisk karakteristik af cytokiner/kemokiner og neuropeptider - Vurdering af bivirkninger i forbindelse med behandlingen med bupivacainsugetablet |
|
E.5.2.1 | 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
|
Prøverne vil blive taget før og efter behandlingsperioderne og materialet vil blive analyseret løbende
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Effect on inflammatory markers |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The trial ends September 2014 |
Forsøget afsluttes i september 2014 |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |