Status:
COMPLETED
Clinical Trial With Bupivacaine Lozenges as Local Anaesthesia Under Upper Gastrointestinal Endoscopy
Lead Sponsor:
Ove Andersen
Collaborating Sponsors:
Oracain II Aps
Conditions:
Application Site Discomfort
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
In this project the investigators want to compare a new anaesthetic method during upper gastroscopic endoscopy, compared to the traditional used method in a private clinic. The new method is a lozenge...
Detailed Description
The research group has previously conducted a clinical study with patients who underwent an UGE at the Department of Gastroenterology, Hvidovre University Hospital, Denmark, where the effect of a new ...
Eligibility Criteria
Inclusion
- Referral from personal doctor for the upper gastroscopic endoscopy
- Age between 18 and 80 year
- Able to speak, read and understand the danish language
- Must be informed orally and released a written consent and a signed authorization statement
Exclusion
- Known allergy to bupivacaine or other local anesthetics of the amide type.
- Pregnancy - the patient will be asked if she uses sufficient contraception. When in doubt a pregnancy test will be performed.
- Breastfeeding
- Use of other medicine before the examination besides the experimental medicine.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01832675
Start Date
March 1 2012
End Date
January 1 2013
Last Update
April 16 2013
Active Locations (1)
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1
Kirurgisk Klinik Hvidovre
Hvidovre, Denmark, 2650