Clinical Trials with bupivacaine lozenge as local anaesthesia under upper gastrointestinal endoscopy

Phase 1

• Conditions: Discomfort during upper gastrointestinal endoscopy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-005622-21-DK
• Lead Sponsor: Clinical Research Centre, Hvidovre University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-08
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Patients undergoing upper gastrointestinal endoscopy.
- Age between 18 and 80 years.
- Ability to speak, read 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) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Known allergy to bupivacain.
- Pregnancy - if in doubt a pregnancy test will be made.
- Breatfeeding.
- Use of other medications in addition to the stydy medication in the endoscopy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified