Trial with lozenges as local pain treatment for head and neck cancer patients with oral inflammation

Clinical trial with lozenges as local pain treatment for head and neck cancer patients with oral mucostis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002346-42-DK

Enrollment

Unknown

Registered

2014-07-14

Start date

2014-09-12

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral pain due to oral mucositis in head and neck cancer patients which are undergoing radiation therapy MedDRA version: 17.1 Level: LLT Classification code 10028130 Term: Mucositis oral System Organ Class: 100000004856 MedDRA version: 17.1 Level: PT Classification code 10037763 Term: Radiation mucositis System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Product Name: Bupizenge Product Code: BUPI25 Pharmaceutical Form: Lozenge INN or Proposed INN: Bupivacaine CAS Number: 38396-39-3 Current Sponsor code: BUPI25 Other descriptive name: BUPIVACAINE HYDR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosed with head and neck cancer and scheduled for radiation therapy - Age between 18 and 80 - Be able to speak, read and understand danish - Be able to give informed written consent - Be able to use an electronic media with a touch screen, such as a smart phone or a tablet PC 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Known allergy to bupivacaine or other local analgesia of the amid type - Pregnancy - Breast feeding women - Use of opioid pain treatment before start of radiation treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if bupivacaine lozenges are an effective and patient friendly pain treatment for oral pain in head and neck cancer patients with oral mucositis and thereby reduce the need for opioids as pain treatment in this patient group compared to standard pain treatment.;Secondary Objective: Reduction of the use of opioids as additional pain treatment in the lozenge group compared to standard treatment group;Primary end point(s): Measurement of the oral pain on a visual analogue scale from 0-100 mm, where 0 = no pain and 100 = worst thinkable oral pain ;Timepoint(s) of evaluation of this end point: The patient has to measure VAS before administration of each bupivacaine lozenge and 60 minutes after. In the control group will VAS be measured every 2 hours.	—

Measure

Time frame

Main Objective: To investigate if bupivacaine lozenges are an effective and patient friendly pain treatment for oral pain in head and neck cancer patients with oral mucositis and thereby reduce the need for opioids as pain treatment in this patient group compared to standard pain treatment.;Secondary Objective: Reduction of the use of opioids as additional pain treatment in the lozenge group compared to standard treatment group;Primary end point(s): Measurement of the oral pain on a visual analogue scale from 0-100 mm, where 0 = no pain and 100 = worst thinkable oral pain ;Timepoint(s) of evaluation of this end point: The patient has to measure VAS before administration of each bupivacaine lozenge and 60 minutes after. In the control group will VAS be measured every 2 hours.

—

Secondary

Measure	Time frame
Secondary end point(s): - Reduction of the patient’s opioid use in the lozenge group compared to the opioid use in the control group measured in mg/day - Reduction in days on opiods in the trial period for the lozenge group compared to the control group. ;Timepoint(s) of evaluation of this end point: End of trial	—

Countries

Denmark

Contacts

Public ContactStine Mogensen

Copenhagen University Hospital, Hvidovre

sugetablet@gmail.com+4538626077

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 9, 2026