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

Clinical Trials with bupivacain lozenge as local anaesthesia under upper gastrointestinal endoscopy - UGE lozenge

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005622-21-DK

Enrollment

Unknown

Registered

2011-12-08

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

Discomfort during upper gastrointestinal endoscopy

Interventions

Product Name: Bupizenge Product Code: BUPI25 Pharmaceutical Form: Lozenge INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE CAS Number: 18010-40-7 Current Sponsor code: BUPI25 Other descriptive name: Bup

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Reduction of discomfort for the patient during upper gastrointestinal endoscopy with administration of bupivacain lozenge compared to lidocaine spray. ;Secondary Objective: Improved patientrating of taste and texture when administrating the bupivacain lozenge.;Primary end point(s): Reduction of discomfort for the patient during upper gastrointestinal endoscopy with administration of bupivacain lozenge compared to lidocaine spray. The patient rates the gag reflexes and discomfort by: - Visual Analog Scale (VAS) 0-10, where 0=no discomfort and 10=extreme discomfort. - 4-point scale (no discomfort, easy discomfort, moderate discomfort and difficult discomfort);Timepoint(s) of evaluation of this end point: It is evaluated right after the performing of the upper gastrointestinal endoscopy.	—

Measure

Time frame

Main Objective: Reduction of discomfort for the patient during upper gastrointestinal endoscopy with administration of bupivacain lozenge compared to lidocaine spray. ;Secondary Objective: Improved patientrating of taste and texture when administrating the bupivacain lozenge.;Primary end point(s): Reduction of discomfort for the patient during upper gastrointestinal endoscopy with administration of bupivacain lozenge compared to lidocaine spray. The patient rates the gag reflexes and discomfort by: - Visual Analog Scale (VAS) 0-10, where 0=no discomfort and 10=extreme discomfort. - 4-point scale (no discomfort, easy discomfort, moderate discomfort and difficult discomfort);Timepoint(s) of evaluation of this end point: It is evaluated right after the performing of the upper gastrointestinal endoscopy.

—

Secondary

Measure	Time frame
Secondary end point(s): Improved patientratings of the taste and texture by administration of bupivacain lozenge.;Timepoint(s) of evaluation of this end point: It is evaluated right after the performing of the upper gastrointestinal endoscopy.	—

Countries

Denmark

Contacts

Public ContactStine Mogensen

Clinical Research Centre, Hvidovre Hospital

sugetablet@gmail.com0045 38 62 60 77

Outcome results

None listed

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