BUPIVACAINE HYDROCHLORIDE MONOHYDRATE for Head and neck cancer|Oral mucositis

Inclusion criteria

• {"criterion_text":"- 1. 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.\n- 2. Male or female aged ≥ 18 on the day of consent and ≤ 80 on the first day of dosing\n- 3. Pathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.\n- 4. 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.\n- 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n- 6. 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

• {"criterion_text":"- 1. 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.\n- 10. Known phenylketonuria (PKU).\n- 11. Pregnancy or breastfeeding.\n- 12. 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).\n- 2. Previous radiation therapy to the head and/or neck area.\n- 3. Pre-existing OM, active herpes simplex virus (HSV) infection, or untreated or uncontrolled oral candidiasis.\n- 4. Receiving high-dose (> 15 mg per day prednisolone), corticosteroids (for any indication).\n- 5. Known allergy or intolerance to bupivacaine, lidocaine, or any of the excipients in the products.\n- 6. Significant cardiac disease such as AV block II-III or requiring treatment with antiarrhythmic drugs in class III (e.g., amiodarone).\n- 7. Inability to eat or drink, or dependence on an enteral feeding tube (percutaneous endoscopic gastrostomy [PEG] or nasogastric tube) for any reason.\n- 8. 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\n- 9. Known diagnosis of epilepsy."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Area under the curve (AUC) of patient-reported oral cavity pain intensity using the Numerical Rating Scale (NRS) from pre-dose to 3 hours post-dose, measured at site on the last day of radiotherapy; comparison between BupiZenge and lidocaine."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"AUC of NRS patient-reported oral cavity pain intensity from pre-dose to 3 hours post-dose measured at site at specified timepoints (day 1 and weeks 1–3); comparison between arms."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Responder = ≥30% reduction in NRS AUC0-3h vs baseline; assessed at last day of radiotherapy and weeks 1–3; between-arm comparison."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Change in NRS pain intensity at 15 minutes post-dose (patient-reported at home); weekly means at specified intervals; comparison between BupiZenge and viscous lidocaine."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Change in NRS pain intensity at 60 minutes post-dose (patient-reported at home); weekly means at specified intervals; between-arm comparison."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Change from pre-dose on day 1 to pre-dose at later timepoints using NRS (patient-reported at home); weekly means; between-arm comparison."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Adverse events/serious adverse events frequency and severity graded by CTCAE v6; monitoring of labs, weight, and vital signs."}
• {"endpoint_text":"- Tolerability: Incidence of dose modifications due to AEs/SAEs","definition_or_measurement_approach":"Incidence of dose modifications attributable to AEs/SAEs."}
• {"endpoint_text":"- Local tolerability in the oral cavity as per visual inspection by the investigator","definition_or_measurement_approach":"Investigator visual inspection assessment of local oral cavity tolerability."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Quantify opioid consumption as oral morphine milligram equivalents (MME) per day during treatment; between-arm comparison."}
• {"endpoint_text":"- Time (days) to initiation of opioid medication during concomitant radiotherapy counted from day of randomization, comparing BupiZenge with lidocaine","definition_or_measurement_approach":"Time in days from randomization to initiation of opioid medication during concomitant radiotherapy; between-arm comparison."}
• {"endpoint_text":"- Change from baseline to last day of radiotherapy in mOMDQ Total Score, comparing BupiZenge with lidocaine","definition_or_measurement_approach":"Change in mOMDQ total score from baseline to last day of radiotherapy; between-arm comparison."}
• {"endpoint_text":"- Change from baseline to last day of radiotherapy in RAND SF-36 Physical Component Summary (PCS) score, comparing BupiZenge with lidocaine","definition_or_measurement_approach":"Change in RAND SF-36 PCS score from baseline to last day of radiotherapy; between-arm comparison."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion progressing from WHO OM Grade 2 to Grade 3+ during treatment with concomitant radiotherapy; between-arm comparison."}
• {"endpoint_text":"- PK parameters in plasma including but not limited to; time vs concentration profiles, AUC0-3h, Cmax, and Tmax","definition_or_measurement_approach":"PK assessments: plasma concentration-time profiles and PK parameters (AUC0-3h, Cmax, Tmax, etc.) in a subset of participants."}
• {"endpoint_text":"- HRUQ Total Score assessed at 30 days post-treatment","definition_or_measurement_approach":"Health resource utilization questionnaire total score assessed 30 days post-treatment."}
• {"endpoint_text":"- WPAI Total Score assessed as change from baseline to 30 days post-treatment","definition_or_measurement_approach":"Work Productivity and Activity Impairment (WPAI) total score change from baseline to 30 days post-treatment."}

Denmark

Earliest CTIS Part Ii Submission Date

01-04-2026

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

27

Number Of Sites

4

Number Of Participants

74

Germany

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

29

Number Of Sites

5

Number Of Participants

25

Sweden

Earliest CTIS Part Ii Submission Date

24-03-2026

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

35

Number Of Sites

1

Number Of Participants

25

Norway

Earliest CTIS Part Ii Submission Date

27-03-2026

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

32

Number Of Sites

2

Number Of Participants

26

Primary sponsor

Full Name

OncoZenge AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Link Medical Research AS

Responsibilities

Codes: 1,11,12,13,5,8

Name

Link Medical ApS

Responsibilities

Codes: 1,11,12,13,5,8

Name

Link Medical GmbH

Responsibilities

Codes: 1,11,12,13,5,8

Name

LINK Medical Research AB

Responsibilities

Codes: 1,11,12,13,5,8

Third parties

• {"country":"Sweden","full_name":"Tamro AB","duties_or_roles":"Labeling and packaging, batch release, Distribution, Procurement of comparator","organisation_type":"Pharmaceutical company"}
• {"country":"Norway","full_name":"Link Medical Research AS","duties_or_roles":"Codes: 1,11,12,13,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"Sweden","full_name":"Lablytica Life Science AB","duties_or_roles":"Code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Sweden","full_name":"Viedoc Technologies AB","duties_or_roles":"Code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Denmark","full_name":"Link Medical ApS","duties_or_roles":"Codes: 1,11,12,13,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Link Medical GmbH","duties_or_roles":"Codes: 1,11,12,13,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"Sweden","full_name":"LINK Medical Research AB","duties_or_roles":"Codes: 1,11,12,13,5,8","organisation_type":"Pharmaceutical company"}