A Phase 3 interventional study of BupiZenge 25 mg and Lidocaine viscous 2% in Head & Neck Cancer and Oral Mucositis, sponsored by OncoZenge AB. Recruiting at 11 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by OncoZenge AB · Phase 3, Interventional, and Treatment
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 pain control improves quality of life and reduces the need for strong pain medicines like opioids.
The main goal is to see how much mouth pain decreases after taking BupiZenge compared to lidocaine. This is measured by asking the patients to rate their pain score on a scale from 0 (no pain) to 10 (worst possible pain). This is done at different time-points, from before the dose until three hours after dose on the last day of radiotherapy.
The study will include 150 adults, both women and men, aged 18 to 80 years, who have head and neck cancer and are scheduled to receive radiotherapy, with or without chemotherapy. These patients will be randomly assigned to one of the treatment groups. The first is BupiZenge, which is a lozenge containing bupivacaine, which dissolves slowly in the mouth. The second is lidocaine, which is a liquid solution for use in the mouth that you gurgle or swish around in the mouth.
The study begins with a combined screening and run-in period that can last up to five weeks. During radiotherapy, patients record their mouth pain each day using a number scale from 0 (no pain) to 10 (worst possible pain). If the pain score is at least 4 (moderate pain) and they have developed mucositis in the mouth within 5 weeks, patients are randomly assigned to receive either BupiZenge or Lidocaine.
Treatment continues at least until radiotherapy is completed. If the patient has pain and mouth sores, and the treatment is working well, it may continue after radiotherapy ends, but only until the sores heal or for a maximum of six weeks in total, whichever occurs first. After treatment ends, there is a 30-day follow-up period.
Pharmacokinetic (PK) parameters of bupivacaine in plasma will be evaluated in a sub-trial including participants randomized to the BupiZenge treatment arm.
Approximately 15 participants (no more than 25), across all designated PK sites, will participate in a PK sub-trial. Blood samples will be collected before the dose and at scheduled time points up to three hours after the dose for PK evaluation. Samples will be analyzed by a central laboratory, and results will be reported to the Sponsor or Sponsor's designee during the course of the trial. Overall, the PK sub-group represents a targeted, ethical, and efficient approach to verify systemic safety parameters for BupiZenge in the intended patient population.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 150 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →This is the only study on the registry with OncoZenge AB as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Moderate/severe liver or kidney disease defined as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bupivacaine hydrochloride, 25 mg lozenge
Drug: BupiZenge 25 mg
Lidocaine hydrochloride oral topical solution, 20 mg/mL
Drug: Lidocaine viscous 2%
1 lozenge as needed. Do not chew or swallow. Dosing interval: ≥ 3 h. Max dose/24 h: 8 lozenges.
10-15 mL as needed. Hold the solution in the mouth and distribute evenly, then either spit out or swallow. Dosing interval ≥ 3 h. Max dose/24 h: 120 mL.
Total pain reduction in oral cavity pain over 3 hours after taking study treatment on the last day of radiotherapy
Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Participants will rate their pain before taking the study treatment and at several time points after dosing. These measurements will be combined to assess how pain changes over time after treatment and to compare BupiZenge with lidocaine.
Time frame: From before to 3 hours after dose, on the last day of radiotherapy
Total pain reduction in oral cavity pain over 3 hours after taking study treatment
Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Participants will rate their pain before taking the study treatment and at several time points after dosing. These measurements will be combined to assess how pain changes over time after treatment and to compare BupiZenge with lidocaine.
Time frame: From before dose to 3 hours after dose, on Day 1 and during Weeks 1 to 3
Proportion of patients with meaningful pain reduction over 3 hours after taking study treatment
Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Patients who achieve at least a 30% reduction in their overall pain will be considered responders. Pain scores will be collected before dosing and at several time points after dosing, and combined to assess the overall change in pain over time. The proportion of responders will be compared between BupiZenge and lidocaine.
Time frame: From before dose to 3 hours after dose, on the last day of radiotherapy and during Weeks 1 to 3
Change in oral cavity pain 15 minutes after taking study treatment
Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Weekly pain changes will be compared between BupiZenge and lidocaine.
Time frame: From before dose to 15 minutes after dose during the week before end of radiotherapy and during Weeks 1 to 3 after radiotherapy
Change in oral cavity pain 60 minutes after taking study treatment
Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Weekly pain changes will be compared between BupiZenge and lidocaine.
Time frame: From before dose to 60 minutes after dose during the week before end of radiotherapy and during Weeks 1 to 3 after radiotherapy
Change in oral cavity pain from Day 1 before dose to later pre-dose assessments
Oral pain will be measured using a 0-10 numerical rating scale. Weekly changes in pain before dose will be compared between BupiZenge and lidocaine.
Time frame: From before dose (Day 1) to before dose during the week before end of radiotherapy and during Weeks 1 to 3 after radiotherapy
Safety as measured frequency and severity of adverse events
Adverse events and serious adverse events will be collected and graded using CTCAE v6.
Time frame: From signature of informed consent up to 30 days after treatment discontinuation
Change from baseline in hematology laboratory parameters.
Hematology laboratory parameters (hemoglobin, hematocrit, red blood cell count, white blood cell count with differential count and platelet count) will be summarized by visit using descriptive statistics, including changes from baseline. The frequency of values below, within, or above the reference range will be summarized by visit.
Time frame: From informed consent to 30 days after treatment discontinuation.
Change from baseline in chemistry laboratory parameters.
Chemistry laboratory parameters (CRP, Albumin, ALT, AST, ALP, Bilirubin (total and conjugated), Calcium, Potassium, Sodium, Creatinine, hCG (if applicable)) will be summarized by visit using descriptive statistics, including changes from baseline. The frequency of values below, within, or above the reference range will be summarized by visit.
Time frame: From informed consent to 30 days after treatment discontinuation.
Changes from baseline in body weight
Body weight will be summarized by visit using descriptive statistics, including changes from baseline. Changes in weight will be expressed as both absolute (kg) and relative (%) changes.
Time frame: From signature of informed consent up to 30 days after treatment discontinuation
Changes from baseline in blood pressure.
Blood pressure will be summarized by visit using descriptive statistics, including changes from baseline.
Time frame: From signature of informed consent up to 30 days after treatment discontinuation
Changes from baseline in heart rate.
Heart rate will be summarized by visit using descriptive statistics, including changes from baseline.
Time frame: From signature of informed consent up to 30 days after treatment discontinuation
Changes from baseline in body temperature .
Body temperature will be summarized by visit using descriptive statistics, including changes from baseline.
Time frame: From signature of informed consent up to 30 days after treatment discontinuation
Changes from baseline in respiratory rate.
Respiratory rate will be summarized by visit using descriptive statistics, including changes from baseline.
Time frame: From signature of informed consent up to 30 days after treatment discontinuation
Tolerability as measured by dose modifications due to adverse events
The number of participants who require dose modifications of study treatment due to adverse events will be recorded.
Time frame: From signature of informed consent up to 30 days after treatment discontinuation
Adverse Events related to local tolerability in the oral cavity, as assessed by CTCAE v6.0, will be summarized.
Local tolerability in the oral cavity will be assessed and the result will be summarized by visit using descriptive statistics. The investigator will inspect the oral mucosa or tongue where the lozenge was placed to assess for any visible irritation or other local reaction. Any observed irritation will be documented and reported as an AE.
Time frame: From Week 2 up to Week 5.
Oral intake of opioids during the treatment period with concomitant BupiZenge/lidocaine treatment and radiotherapy comparing BupiZenge with lidocaine.
Use of opioid pain medication will be recorded and converted to oral morphine milligram equivalents (MME) per day. Opioid use will be compared between BupiZenge and lidocaine.
Time frame: From randomization up to Week 5.
Time (days) to start of opioid medication during radiotherapy comparing BupiZenge with lidocaine
The number of days from randomization until the participant first starts opioid pain medication will be recorded and compared between BupiZenge and lidocaine.
Time frame: From randomization up to Week 5.
Change in Modified Oral Mucositis Daily Questionnaire (mOMDQ) Total Score
Participants will complete the mOMDQ. Changes in the total score will be compared between BupiZenge and lidocaine.
Time frame: From randomization up to Week 5.
Quality-of-life measured as change from baseline using RAND SF-36 questionnaire
Participants will complete the Quality-of-life questionnaire RAND SF-36. The Physical Component Summary (PCS) score will be calculated according to the RAND SF-36 scoring algorithm. Change from baseline in PCS score will be summarized using descriptive statistics.
Time frame: From randomization up to Week 5.
Progression of oral mucositis from WHO Grade 2 to Grade 3 or higher
The proportion of participants with worsening of oral mucositis, from WHO Grade 2 to Grade 3 or higher, during radiotherapy will be assessed and compared between BupiZenge and lidocaine.
Time frame: From randomization up to Week 5.
Maximum Plasma Concentration [Cmax] of bupivaccaine in plasma.
Blood samples will be collected from approximately 15 of the participants receiving BupiZenge treatment.
Time frame: Before the dose up to three hours after the dose. Two occasions per participant during the six-week treatment period
Maximum Plasma Concentration [Cmax] of bupivaccaine in plasma.
Blood samples will be collected from approximately 15 of the participants receiving BupiZenge treatment. Plasma concentrations of bupivacaine will be summarized descriptively at each time-point and visit they are assessed.
Time frame: Before the dose up to three hours after the dose. Two occasions per participant during the six-week treatment period
Time to maximum Plasma Concentration [Tmax] of bupivaccaine in plasma.
Blood samples will be collected from approximately 15 of the participants receiving BupiZenge treatment. Plasma concentrations of bupivacaine will be summarized descriptively at each time-point and visit they are assessed. Tmax will be summarized using median and range.
Time frame: Before the dose up to three hours after the dose. Two occasions per participant during the six-week treatment period
Area under the plasma concentration-time curve from time zero to 3 hours after dose (AUC0-3h)
Blood samples will be collected from approximately 15 of the participants receiving BupiZenge treatment. AUC 0-3h will be summarized descriptively at each time-point and visit they are assessed.
Time frame: Before the dose up to three hours after the dose. Two occasions per participant during the six-week treatment period
Health Resource Utilization Questionnaire (HRUQ) Total Score at 30 days after treatment
Participants will complete the HRUQ. The questionnaire is structure for collecting healthcare utilization data in clinical research and health-economic evaluation. The total score will be compared between BupiZenge and lidocaine.
Time frame: Assessed 30 days after end of treatment
Change in Work Productivity and Activity Impairment (WPAI) Total Score from baseline to 30 days after treatment
Participants will complete the WPAI questionnaire. Change from baseline in total score will be summarized using descriptive statistics.
Time frame: From screening to 30 days after end of treatment
Plan to share: No — Individual participant data will not be shared due to company policy and to protect participant privacy and confidential information.
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