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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
EU CTIS ID: 2025-524386-24-00
What this study is testing
To evaluate the effect of BupiZenge on patient-reported oral cavity pain
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 2. Male or female aged ≥ 18 on the day of consent and ≤ 80 on the first day of dosing
- 3. Pathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.
- 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.
- 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- 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.
You likely can't join if
- 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.
- 10. Known phenylketonuria (PKU).
- 11. Pregnancy or breastfeeding.
- 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).
- 2. Previous radiation therapy to the head and/or neck area.
- 3. Pre-existing OM, active herpes simplex virus (HSV) infection, or untreated or uncontrolled oral candidiasis.
See the full eligibility criteria
Who can join
- 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.
- 2. Male or female aged ≥ 18 on the day of consent and ≤ 80 on the first day of dosing
- 3. Pathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.
- 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.
- 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- 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.
What rules you out
- 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.
- 10. Known phenylketonuria (PKU).
- 11. Pregnancy or breastfeeding.
- 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).
- 2. Previous radiation therapy to the head and/or neck area.
- 3. Pre-existing OM, active herpes simplex virus (HSV) infection, or untreated or uncontrolled oral candidiasis.
- 4. Receiving high-dose (> 15 mg per day prednisolone), corticosteroids (for any indication).
- 5. Known allergy or intolerance to bupivacaine, lidocaine, or any of the excipients in the products.
- 6. Significant cardiac disease such as AV block II-III or requiring treatment with antiarrhythmic drugs in class III (e.g., amiodarone).
- 7. Inability to eat or drink, or dependence on an enteral feeding tube (percutaneous endoscopic gastrostomy [PEG] or nasogastric tube) for any reason.
- 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
- 9. Known diagnosis of epilepsy.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.