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Clinical Trials/EUCTR2011-006196-19-DK
EUCTR2011-006196-19-DK
Active, not recruiting
Phase 1

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

Clinical Research Centre, Hvidovre University Hospital0 sites60 target enrollmentJanuary 30, 2012

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Clinical Research Centre, Hvidovre University Hospital
Enrollment
60
Status
Active, not recruiting
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 30, 2012
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Clinical Research Centre, Hvidovre University Hospital

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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