2025-524386-24-00
Recruiting
Phase 3
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
OncoZenge AB12 sites in 4 countries150 target enrollmentStarted: May 19, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- OncoZenge AB
- Enrollment
- 150
- Locations
- 12
- Primary Endpoint
- Total pain reduction from baseline expressed as area under the curve (AUC) of patient-reported oral cavity pain intensity from pre-dose to 3 hours post-dose, measured by the NRS (patient-reported at site) at the last day of radiotherapy, comparing BupiZenge with lidocaine.
Overview
Brief Summary
To evaluate the effect of BupiZenge on patient-reported oral cavity pain
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
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-
- •Female participants of childbearing potential (WOCBP) must agree to use at least an acceptable effective method of contraception or practice total 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.
- •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).
- •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.
Arms & Interventions
BupiZenge
Test
Intervention: BupiZenge (Drug)
Lidocaine
Comparator
Intervention: Lidocaine (Drug)
Outcomes
Primary Outcomes
Total pain reduction from baseline expressed as area under the curve (AUC) of patient-reported oral cavity pain intensity from pre-dose to 3 hours post-dose, measured by the NRS (patient-reported at site) at the last day of radiotherapy, comparing BupiZenge with lidocaine.
Total pain reduction from baseline expressed as area under the curve (AUC) of patient-reported oral cavity pain intensity from pre-dose to 3 hours post-dose, measured by the NRS (patient-reported at site) at the last day of radiotherapy, comparing BupiZenge with lidocaine.
Secondary Outcomes
- Total pain reduction from baseline, expressed as AUC of patient-reported oral cavity pain intensity from pre-dose to 3 hours post-dose, measured by the NRS (patient-reported at site) at day 1 and at each of week 1 to 3 of treatment with BupiZenge/lidocaine comparing BupiZenge with lidocaine.
- Proportion of responders defined as a 30% reduction in pain NRS AUC0-3h compared to baseline at the last day of radiotherapy and at each of weeks 1 to 3, comparing BupiZenge with lidocaine.
- Change from pre-dose (on same day) in oral cavity pain intensity at 15 minutes post-dose (NRS; patient-reported at home), comparing BupiZenge with viscous lidocaine at the week preceding end of radiotherapy and at each of week 1 to week 3 after radiotherapy (including only data when participants on concomitant radiotherapy) (weekly means).
- Oral consumption of opioids during the treatment period with concomitant BupiZenge/lidocaine treatment and radiotherapy quantified as oral morphine milligram equivalents (MME) per day comparing BupiZenge with lidocaine.
- Change from pre-dose (on same day) in oral cavity pain intensity at 60 minutes post-dose (NRS; patient-reported at home), comparing BupiZenge with viscous lidocaine at the week preceding end of radiotherapy and at each of week 1 to week 3 after radiotherapy (including only data when participants on concomitant radiotherapy) (weekly means).
- Change from pre-dose (day 1) in oral cavity pain intensity to pre-dose (NRS; patient-reported at home), comparing BupiZenge with viscous lidocaine at the week preceding end of radiotherapy and at each of week 1 to week 3 after radiotherapy (including only data when participants on concomitant radiotherapy) (weekly means)
- Safety: Frequency and severity of AEs and SAEs as per common terminology criteria for AEs (CTCAE) v6, including changes from baseline in safety laboratory values, body weight, and vital signs
- Tolerability: Incidence of dose modifications due to AEs/SAEs
- Local tolerability in the oral cavity as per visual inspection by the investigator
- Time (days) to initiation of opioid medication during concomitant radiotherapy counted from day of randomization, comparing BupiZenge with lidocaine
- Change from baseline to last day of radiotherapy in mOMDQ Total Score, comparing BupiZenge with lidocaine
- Change from baseline to last day of radiotherapy in RAND SF-36 Physical Component Summary (PCS) score, comparing BupiZenge with lidocaine
- Proportion of participants who progress from WHO Grade 2 to Grade 3 or higher during the treatment period with concomitant radiotherapy, comparing BupiZenge with lidocaine
- PK parameters in plasma including but not limited to; time vs concentration profiles, AUC0-3h, Cmax, and Tmax
- HRUQ Total Score assessed at 30 days post-treatment
- WPAI Total Score assessed as change from baseline to 30 days post-treatment
Investigators
Marie-Louise Fjällskog
Scientific
OncoZenge AB
Study Sites (12)
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