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

NCT ID
NCT07672236
Registry status
Recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
OncoZenge AB
Conditions
Head & Neck Cancer, Oral Mucositis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Randomized, Open-label, Phase III Trial to Assess the Efficacy and Safety of BupiZenge Compared to Lidocaine for Pain Associated With Oral Mucositis in Head and Neck Cancer

Enrollment: 150 participants (Estimated).

What is being studied

  • Drug: BupiZenge 25 mg
  • Drug: Lidocaine viscous 2%

Who may be eligible

Ages
18 Years to 80 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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. Exclusion Criteria: * 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: 1. AST/ALT \> 3 × upper limit of normal (ULN) or bilirubin \> 1.5 × ULN (unless related to Gilbert's syndrome) 2. 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).

Study locations

11 study locations are listed.

Recruiting site status is explicitly provided for 11 locations; 6 are listed as Recruiting.

Countries: Denmark, Germany, Norway, Sweden

Sample of listed locations

  • Rigshospitalet, Copenhagen University Hospital — Copenhagen, 2100, Denmark — Recruiting
  • Næstved Hospital — Næstved, 4700, Denmark — Recruiting
  • University Hospital Frankfurt (AöR) — Frankfurt am Main, 60596, Germany — Recruiting
  • Helse Bergen HF — Bergen, 5021, Norway — Recruiting
  • Oslo University Hospital HF — Oslo, 0379, Norway — Recruiting
  • Karolinska University Hospital — Stockholm, SE-17164, Sweden — Recruiting
  • Herlev Hospital — Herlev, 2730, Denmark — Not yet recruiting
  • University Hospital Cologne (Universitätsklinikum Köln AöR) — Cologne, 50937, 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

Study details

Start date
July 7, 2026
Primary completion date
December 23, 2026
Completion date
January 31, 2027
First posted
June 26, 2026
Collaborators
LINK Medical Research AB

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07672236
Registry last updated
September 9, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07672236 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Neck Pain studies | Clinical trial FAQ