A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.

NCT07672236 | Recruiting Phase 3

• 2 other identifiers: BZ0032025-524386-24-00
• Study Type: interventional
• Target: 150
• Locations: 4 countries
• Sites: 11

Brief Summary

Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain. The sores usually start in the third week of radiation and last aboutfive weeks, often continuing for two weeks after treatment ends. Current pain treatments, for instance lidocaine solution, only give short-lasting pain relief. BupiZenge is a lozenge that dissolves slowly in the mouth and contains bupivacaine. Bupivacaine is a long-acting pain-relieving medicine and has been safely used for many years for both children and adults, and its safety profile is well understood. The BupiZenge lozenge is designed to give longer and more reliable pain relief for patients with mucositis in their mouth. This study will check if BupiZenge works better to reduce pain than lidocaine, and if better pain control improves quality of life and reduces the need for strong pain medicines like opioids. The main goal is to see how much mouth pain decreases after taking BupiZenge compared to lidocaine. This is measured by asking the patients to rate their pain score on a scale from 0 (no pain) to 10 (worst possible pain). This is done at different time-points, from before the dose until three hours after dose on the last day of radiotherapy. The study will include 150 adults, both women and men, aged 18 to 80 years, who have head and neck cancer and are scheduled to receive radiotherapy, with or without chemotherapy. These patients will be randomly assigned to one of the treatment groups. The first is BupiZenge, which is a lozenge containing bupivacaine, which dissolves slowly in the mouth. The second is lidocaine, which is a liquid solution for use in the mouth that you gurgle or swish around in the mouth. The study begins with a combined screening and run-in period that can last up to five weeks. During radiotherapy, patients record their mouth pain each day using a number scale from 0 (no pain) to 10 (worst possible pain). If the pain score is at least 4 (moderate pain) and they have developed mucositis in the mouth within 5 weeks, patients are randomly assigned to receive either BupiZenge or Lidocaine. Treatment continues at least until radiotherapy is completed. If the patient has pain and mouth sores, and the treatment is working well, it may continue after radiotherapy ends, but only until the sores heal or for a maximum of six weeks in total, whichever occurs first. After treatment ends, there is a 30-day follow-up period.

Conditions

Head & Neck Cancer; Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Total pain reduction in oral cavity pain over 3 hours after taking study treatment on the last day of radiotherapy

  Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Participants will rate their pain before taking the study treatment and at several time points after dosing. These measurements will be combined to assess how pain changes over time after treatment and to compare BupiZenge with lidocaine.

  From before to 3 hours after dose, on the last day of radiotherapy

Secondary Outcomes (26)

• Total pain reduction in oral cavity pain over 3 hours after taking study treatment

  From before dose to 3 hours after dose, on Day 1 and during Weeks 1 to 3

• Proportion of patients with meaningful pain reduction over 3 hours after taking study treatment

  From before dose to 3 hours after dose, on the last day of radiotherapy and during Weeks 1 to 3

• Change in oral cavity pain 15 minutes after taking study treatment

  From before dose to 15 minutes after dose during the week before end of radiotherapy and during Weeks 1 to 3 after radiotherapy

• Change in oral cavity pain 60 minutes after taking study treatment

  From before dose to 60 minutes after dose during the week before end of radiotherapy and during Weeks 1 to 3 after radiotherapy

• Change in oral cavity pain from Day 1 before dose to later pre-dose assessments

  From before dose (Day 1) to before dose during the week before end of radiotherapy and during Weeks 1 to 3 after radiotherapy

Study Arms (2)

BupiZenge

EXPERIMENTAL

Bupivacaine hydrochloride, 25 mg lozenge

Drug: BupiZenge 25 mg

Lidocaine

ACTIVE COMPARATOR

Lidocaine hydrochloride oral topical solution, 20 mg/mL

Drug: Lidocaine viscous 2%

Interventions

BupiZenge 25 mg DRUG

1 lozenge as needed. Do not chew or swallow. Dosing interval: ≥ 3 h. Max dose/24 h: 8 lozenges.

BupiZenge

Lidocaine viscous 2% DRUG

10-15 mL as needed. Hold the solution in the mouth and distribute evenly, then either spit out or swallow. Dosing interval ≥ 3 h. Max dose/24 h: 120 mL.

Lidocaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must provide signed written informed consent prior to trial participation and must be willing and able to comply with all requirements and restrictions of the trial.
• Male or female aged ≥ 18 on the day of consent and ≤ 80 on the first day of dosing.
• Pathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.
• About to start IMRT with curative intent with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative intended dose of at least 60 Gy and a maximum of 72 Gy. Proton therapy given at equivalent biological doses is allowed.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
• Female participants of childbearing potential (WOCBP) must agree to use a highly effective contraceptive measure or practice total sexual abstinence from the time of giving informed consent until at least 24 hours after last dose of IMP.

You may not qualify if:

• Participation in another investigational interventional clinical trial within 3 months prior to first dosing, or for a longer period if required by local regulations, or within 5 half-lives of the investigational agent taken (whichever is longer). An exception is studies where patients are randomized to different radiotherapy settings, e.g. participation in DAHANCA 35 is allowed.
• Previous radiation therapy to the head and/or neck area.
• Pre-existing OM, active herpes simplex virus (HSV) infection, or untreated or uncontrolled oral candidiasis.
• Receiving high-dose (\> 15 mg per day prednisolone), corticosteroids (for any indication).
• Known allergy or intolerance to bupivacaine, lidocaine, or any of the excipients in the products.
• Significant cardiac disease such as AV block II-III or requiring treatment with antiarrhythmic drugs in class III (e.g., amiodarone).
• Inability to eat or drink, or dependence on an enteral feeding tube (percutaneous endoscopic gastrostomy \[PEG\] or nasogastric tube) for any reason.
• Moderate/severe liver or kidney disease defined as:
• AST/ALT \> 3 × upper limit of normal (ULN) or bilirubin \> 1.5 × ULN (unless related to Gilbert's syndrome)
• glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2
• Known diagnosis of epilepsy.
• Known phenylketonuria (PKU).
• Pregnancy or breastfeeding.
• Any condition or circumstance-based on the investigator's assessment-that could increase risk to the participant, confound trial results, or interfere with compliance / participation (including inability or unwillingness to follow trial procedures, or any clinically significant physical or psychiatric condition).

Sponsors & Collaborators

• OncoZenge AB: lead
• LINK Medical Research AB: collaborator

Study Sites (11)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

Herlev Hospital

Herlev, 2730, Denmark

NOT YET RECRUITING

Næstved Hospital

Næstved, 4700, Denmark

RECRUITING

University Hospital Cologne (Universitätsklinikum Köln AöR)

Cologne, 50937, Germany

NOT YET RECRUITING

University Hospital Frankfurt (AöR)

Frankfurt am Main, 60596, Germany

NOT YET RECRUITING

Medical Center - University Of Freiburg

Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

University Hospital Schleswig-Holstein (AöR)

Kiel, 24105, Germany

NOT YET RECRUITING

University Hospital Tübingen (AöR)

Tübingen, 72076, Germany

NOT YET RECRUITING

Helse Bergen HF

Bergen, 5021, Norway

RECRUITING

Oslo University Hospital HF

Oslo, 0379, Norway

RECRUITING

Karolinska University Hospital

Stockholm, SE-17164, Sweden

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Chief Medical Officer (CMO)

  OncoZenge AB

  STUDY DIRECTOR

Central Study Contacts

Chief Executive Officer (CEO)

CONTACT

+468311420; info@oncozenge.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 26, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); NO (2); DK (3); SE (1)