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

RecruitingPhase 3Ages 18 Years - 80 YearsAllOncoZenge AB
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In plain words

What the trial is, and whether it could suit you

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 pa

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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).
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What it tests

  • BupiZenge 25 mg
  • Lidocaine viscous 2%
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Where

11 sites
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Næstved Hospital
Næstved, Denmark
University Hospital Cologne (Universitätsklinikum Köln AöR)
Cologne, Germany
University Hospital Frankfurt (AöR)
Frankfurt am Main, Germany
Medical Center - University Of Freiburg
Freiburg im Breisgau, Germany
University Hospital Schleswig-Holstein (AöR)
Kiel, Germany
University Hospital Tübingen (AöR)
Tübingen, Germany

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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